ANSWER: Oracea Soolantra Association in Participants With Severe Rosacea

Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT03075891
Collaborator
(none)
273
21
2
7.2
13
1.8

Study Details

Study Description

Brief Summary

The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical cream associated with Placebo in the treatment of severe Rosacea.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ivermectin 1% cream
  • Drug: Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules
  • Other: Oral placebo capsules
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
273 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy Comparison of Ivermectin 1% Topical Cream Associated With Doxycycline 40 mg Modified Release (MR) Capsules Versus Ivermectin 1% Topical Cream Associated With Placebo in the Treatment of Severe Rosacea
Actual Study Start Date :
Jul 5, 2017
Actual Primary Completion Date :
Feb 8, 2018
Actual Study Completion Date :
Feb 8, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ivermectin 1% cream + Doxycycline 40 mg MR capsules

Drug: Ivermectin 1% cream
Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks

Drug: Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules
1 Capsule once-daily for 12 weeks

Placebo Comparator: Ivermectin 1% cream + Oral placebo capsules

Drug: Ivermectin 1% cream
Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks

Other: Oral placebo capsules
1 Capsule once-daily for 12 weeks

Outcome Measures

Primary Outcome Measures

  1. Percent Change From Baseline in Inflammatory Lesion Count at Week 12 [Baseline, Week 12]

    Percent change from baseline in inflammatory lesion count at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (that is [i.e.] papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter (cm) in diameter; and Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.

Secondary Outcome Measures

  1. Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8 [Baseline, Weeks 4 and 8]

    Percent change from baseline in inflammatory lesion count at Weeks 4 and 8 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.

  2. Percentage of Participants With Clear Inflammatory Lesions at Week 12 [Week 12]

    Percentage of participants with clear inflammatory lesions at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 cm in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.

  3. Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 [Weeks 4, 8 and 12]

    Percentage of participants with 100% reduction in inflammatory lesions at Weeks 4, 8 and 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.

  4. Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12 [Weeks 4, 8 and 12]

    The evaluator assessed the participant's diffuse persistent facial erythema of rosacea by performing a static ("snap shot") evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome.

  5. Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 [Weeks 4, 8 and 12]

    The evaluator assessed the participant's diffuse persistent facial erythema of rosacea by performing a static ("snap shot") evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome.

  6. Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12 [Weeks 4, 8 and 12]

    The evaluator assessed the participant's rosacea by performing a static ("snap shot") evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema).

  7. Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 [Weeks 4, 8 and 12]

    The evaluator assessed the participant's rosacea by performing a static ("snap shot") evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema).

  8. Stinging/Burning Severity Score at Weeks 4, 8 and 12 [Weeks 4, 8 and 12]

    The evaluator recorded the severity of the participant's facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort).

  9. Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 [Weeks 4, 8 and 12]

    The evaluator recorded the severity of the participant's facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort).

  10. Global Improvement Total Score at Week 12 (Last Visit/Early Termination) [Week 12 (last visit/early termination)]

    Participants were evaluated for his/her improvement in rosacea compared to his/her rosacea condition before study, using global Improvement scale. It is a 7 item scale where, 0=complete improvement (all signs and symptoms of disease have resolved [100% improvement]); 1=excellent improvement (nearly all signs and symptoms cleared [90% improvement]. Only minimal residual signs and symptoms remain); 2=very good improvement (majority of the signs and symptoms have resolved [about 75% improvement]); 3=good improvement (significant improvement, but many signs and symptoms remain [about 50% improvement]); 4=minimal improvement (slight overall improvement, but not clinically significant [about 25% improvement]); 5=no change (overall severity similar to baseline); 6=worse (worse than baseline).

  11. Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination) [Week 12 (last visit/early termination)]

    Participants were to evaluated for his/her improvement in rosacea compared to his/her rosacea condition before study, using global Improvement scale. it is a 7 item scale where, 0=complete improvement (all signs and symptoms of disease have resolved [100% improvement]); 1=excellent improvement (nearly all signs and symptoms cleared [90% improvement]. Only minimal residual signs and symptoms remain); 2=very good improvement (majority of the signs and symptoms have resolved [about 75% improvement]); 3=good improvement (significant improvement, but many signs and symptoms remain [about 50% improvement]); 4=minimal improvement (slight overall improvement, but not clinically significant [about 25% improvement]); 5=no change (overall severity similar to baseline); 6=worse (worse than baseline). .

  12. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [From the signing of the informed consent form (ICF) up to Week 12]

    An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE was any untoward medical occurrence that at any dose: results in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.

  13. Dermatology Life Quality Index (DLQI) Questionnaire Total Score at Week 12 (Last Visit/Early Termination Visit) [Week 12 (last visit/early termination)]

    DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of-life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0- 3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease.

  14. Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category [Baseline, Week 12 (last visit/early termination)]

    Impact of study treatments on subjects' quality of life was measured by using DLQI questionnaire. DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of-life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0- 3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease.

  15. Percent Change From Baseline in Dermatology Life Quality Index Questionnaire Total Score at Week 12 (Last Visit/Early Termination) [Baseline, Week 12 (last visit/early termination)]

    Percent Change from Baseline in Dermatology Life Quality Index questionnaire Total Score at Last Visit. DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0-3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease.

  16. EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire at Week 12 (Last Visit/Early Termination Visit) [Week 12/Last visit or early termination visit]

    EQ-5D-5L is a 5-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprised of 5 levels with corresponding numeric scores, where 1 indicated no problems, and 5 indicated extreme problems. Participant selected answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-5L total score indicates improvement.

  17. Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) [Baseline, Week 12 (last visit/early termination)]

    EQ-5D-5L is a 5-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprised of 5 levels with corresponding numeric scores, where 1 indicated no problems, and 5 indicated extreme problems. Participant selected answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-5L total score indicates improvement.

  18. Percentage of Participants Reported Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire for Currently Employed Question at Week 12 (Last Visit/Early Termination Visit) [Week 12 (Last visit/early termination visit)]

    WPAI:GH questionnaire was an instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. Currently Employed question was assessed in this outcome measure.

  19. Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire - Hours Missed at Work, Impact to Productivity at Work and Daily Activities at Week 12 [Week 12 (Last visit/Early termination visit)]

    WPAI:GH questionnaire is an instrument to measure impairment in both paid and unpaid work during the past week including questions: missed hours from work because of rosacea?, missed hours from work because of other reason?, number of Working hours. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.

  20. Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire (How Much Rosacea Affect Productivity at Work, How Much Rosacea Affect Daily Activity) at Week 12 (Last Visit/Early Termination Visit) [Week 12 (Last visit/Early termination visit)]

    WPAI:GH questionnaire is an instrument to measure impairment in both paid and unpaid work during the past week, on a scale ranging from 0 (health problems had no effect) to 10 (health problems completely prevented them from working) including questions: 5) how much rosacea affect productivity at work?; 6) how much rosacea affect daily activity?. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicated little or no impact of health problems on work and activities, and a negative change in the WPAI score indicated improvement."

  21. Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A [Week 12 (Last visit/early termination visit)]

    Subject's satisfaction questionnaire was used to specifically collect the subjects' feedback on the treatment regimen, the level of satisfaction and future usage. Questionnaire consisted of 4 parts: Part A, B, C and D. where Part A consisted of following 12 questions about study drugs (capsules and cream): 1-Time the study regimen took to work, 2-Improvement of facial lesions, 3-Improvement of facial redness, 4-Improvement of ocular symptoms, 5-Improvement of flushing episodes, 6-How bothered by side effects, 7-Your face looks, 8-You feel, 9-Easy to incorporate in daily routine, 10-Using the study regimen again, 11-Overall satisfaction, 12-Compared to last treatment. Satisfied score of questionnaire meant as participants responded as Very satisfied (Questions-1,2,3,4,5,11), Not bothered at all (Question-6), A lot better (Questions- 7,8,12), yes (Question-10), strongly agree (Question-9).

  22. Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B [Week 12 (Last visit/early termination visit)]

    Part B of Questionnaire consisted of following 10 questions about both provided skin care products cleanser and moisturizer: 1-Easy to incorporate into a daily routine, 2-Recommend to my family or friends, 3-Help my skin look healthier, 4-More confident with rosacea, 5-More confident with skin appearance, 6-Positive difference in the appearance, 7-Keep using both skin care products, 8-Make my skin more hydrated, 9-Improve the texture of my skin, 10-Pleasant to use.

  23. Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part C [Week 12 (Last visit or early termination visit)]

    Part C subject satisfaction questionnaire consisted of following 4 questions about the cosmetic product cleanser: 1-Clean healthy skin feeling, 2-Deep cleansing without stripping moisture, 3-Rinsed off easily, 4-Not make my skin feel tight or dry.

  24. Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part D [Week 12 (Last visit/early termination visit)]

    Part D of subject satisfaction questionnaire consisted of following 4 questions about the cosmetic product moisturizer: 1-Skin feel soft and smooth, 2-Improve my skin moisture, 3-Leave my skin hydrated and protected, 4-Provide comforting sensation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male or female subject age ≥ 18 years or older;

  • Subject with a minimum of 20 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face at Baseline visit;

  • Subject with severe rosacea with papulopustular lesions (according to the Investigator's Global Assessment (IGA) score rated 4);

  • Female subjects of childbearing potential with a negative urine pregnancy test (UPT);

  • Female subjects of childbearing potential must practice a highly effective method of contraception during the study.

Exclusion Criteria:
  • Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;

  • Subjects with more than 2 nodules of rosacea on the face;

  • Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;

  • Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients doxycycline and ivermectin.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Private Practice Fort Smith Arkansas United States 72916
2 Private practice Sacramento California United States 95819
3 Private practice Boca Raton Florida United States 33486
4 Private practice Louisville Kentucky United States 40202
5 Private practice Louisville Kentucky United States 40241
6 Private Practice Metairie Louisiana United States 70001
7 Private practice Omaha Nebraska United States 68144
8 Private practice Las Vegas Nevada United States 89148
9 Private practice Pflugerville Texas United States 78660
10 Private practice Markham Canada
11 Private practice Montréal Canada
12 Private practice Peterborough Canada
13 Private practice Richmond Hill Canada
14 Private practice Waterloo Canada
15 Private practice Budapest Hungary
16 University Debrecen Hungary
17 Hospital Miskolc Hungary
18 Private practice Pécel Hungary
19 University Pécs Hungary
20 University Szeged Hungary
21 Private practice Szolnok Hungary

Sponsors and Collaborators

  • Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT03075891
Other Study ID Numbers:
  • RD.03.SPR.113322
First Posted:
Mar 9, 2017
Last Update Posted:
Mar 16, 2021
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details This study was conducted at 39 sites in Canada, Czech Republic, Germany, Hungary, Poland, and United States of America between 05 July 2017 to 08 February 2018.
Pre-assignment Detail A total of 273 participants were randomized and treated, out of which 251 participants completed the study.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% (percent) cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg (milligram) Modified Release (MR) (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks. Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Period Title: Overall Study
STARTED 135 138
COMPLETED 126 125
NOT COMPLETED 9 13

Baseline Characteristics

Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules Total
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks. Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks. Total of all reporting groups
Overall Participants 135 138 273
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
109
80.7%
110
79.7%
219
80.2%
>=65 years
26
19.3%
28
20.3%
54
19.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
52.4
(13.5)
51.6
(13.3)
52
(13.4)
Sex: Female, Male (Count of Participants)
Female
75
55.6%
80
58%
155
56.8%
Male
60
44.4%
58
42%
118
43.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
2
1.4%
2
0.7%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
1
0.7%
0
0%
1
0.4%
White
133
98.5%
136
98.6%
269
98.5%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
1
0.7%
0
0%
1
0.4%
Skin phototype (Count of Participants)
Skin phototype I
5
3.7%
11
8%
16
5.9%
Skin phototype II
82
60.7%
83
60.1%
165
60.4%
Skin phototype III
37
27.4%
38
27.5%
75
27.5%
Skin phototype IV
8
5.9%
6
4.3%
14
5.1%
Skin phototype V
1
0.7%
0
0%
1
0.4%
Skin phototype VI
2
1.5%
0
0%
2
0.7%

Outcome Measures

1. Primary Outcome
Title Percent Change From Baseline in Inflammatory Lesion Count at Week 12
Description Percent change from baseline in inflammatory lesion count at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (that is [i.e.] papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter (cm) in diameter; and Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
Intent-to-treat (ITT) population consisted of the entire population enrolled and randomized. The last observation carried forward (LOCF) method was used to impute missing values for inflammatory lesion count.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks. Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Measure Participants 135 138
Mean (Standard Deviation) [percent change]
-80.29
(21.65)
-73.56
(30.52)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules, Ivermectin 1% Cream + Oral Placebo Capsules
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.032
Comments
Method Cochran-Mantel-Haenszel
Comments
2. Secondary Outcome
Title Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8
Description Percent change from baseline in inflammatory lesion count at Weeks 4 and 8 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.
Time Frame Baseline, Weeks 4 and 8

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Week 4
-48.15
(26.71)
-39.27
(27.93)
Week 8
-69.14
(24.10)
-61.44
(28.74)
3. Secondary Outcome
Title Percentage of Participants With Clear Inflammatory Lesions at Week 12
Description Percentage of participants with clear inflammatory lesions at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 cm in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Number [percentage of participants]
17.8
13.2%
7.2
5.2%
4. Secondary Outcome
Title Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12
Description Percentage of participants with 100% reduction in inflammatory lesions at Weeks 4, 8 and 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.
Time Frame Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Week 4: Yes
1.5
1.1%
0.0
0%
Week 4: No
98.5
73%
100.0
72.5%
Week 8: Yes
5.2
3.9%
2.9
2.1%
Week 8: No
94.8
70.2%
97.1
70.4%
Week 12: Yes
17.8
13.2%
7.2
5.2%
Week 12: No
82.2
60.9%
92.8
67.2%
5. Secondary Outcome
Title Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12
Description The evaluator assessed the participant's diffuse persistent facial erythema of rosacea by performing a static ("snap shot") evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome.
Time Frame Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Week 4
2.47
(0.94)
2.56
(0.94)
Week 8
1.85
(0.95)
1.97
(0.94)
Week 12
1.51
(1.02)
1.58
(0.95)
6. Secondary Outcome
Title Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12
Description The evaluator assessed the participant's diffuse persistent facial erythema of rosacea by performing a static ("snap shot") evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome.
Time Frame Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Week 4 (0= Clear skin)
0.7
0.5%
0.7
0.5%
Week 4 (1= Almost clear)
16.3
12.1%
12.3
8.9%
Week 4 (2= Mild erythema)
31.9
23.6%
34.1
24.7%
Week 4 (3= Moderate erythema)
37.8
28%
36.2
26.2%
Week 4 (4= Severe erythema)
13.3
9.9%
16.7
12.1%
Week 8 (0= Clear skin)
5.2
3.9%
1.4
1%
Week 8 (1= Almost clear)
31.1
23%
33.3
24.1%
Week 8 (2= Mild erythema)
43.7
32.4%
39.1
28.3%
Week 8 (3= Moderate erythema)
13.3
9.9%
18.8
13.6%
Week 8 (4= Severe erythema)
6.7
5%
7.2
5.2%
Week 12 (0= Clear skin)
14.1
10.4%
7.2
5.2%
Week 12 (1= Almost clear)
41.5
30.7%
47.8
34.6%
Week 12 (2= Mild erythema)
28.1
20.8%
29.7
21.5%
Week 12 (3= Moderate erythema)
11.9
8.8%
10.1
7.3%
Week 12 (4= Severe erythema)
4.4
3.3%
5.1
3.7%
7. Secondary Outcome
Title Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12
Description The evaluator assessed the participant's rosacea by performing a static ("snap shot") evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema).
Time Frame Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Week 4
2.59
(0.88)
2.84
(0.83)
Week 8
1.78
(0.83)
2.04
(0.93)
Week 12
1.34
(0.89)
1.57
(0.95)
8. Secondary Outcome
Title Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12
Description The evaluator assessed the participant's rosacea by performing a static ("snap shot") evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema).
Time Frame Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Week 4 (0 - Clear)
1.5
1.1%
0.7
0.5%
Week 4 (1 - Almost clear)
11.1
8.2%
5.1
3.7%
Week 4 (2- Mild)
25.2
18.7%
23.9
17.3%
Week 4 (3 - Moderate)
51.9
38.4%
50.0
36.2%
Week 4 (4 - Severe)
10.4
7.7%
20.3
14.7%
Week 8 (0 - Clear)
3.0
2.2%
3.6
2.6%
Week 8 (1 - Almost clear)
34.8
25.8%
22.5
16.3%
Week 8 (2 - Mild)
48.1
35.6%
47.8
34.6%
Week 8 (3 - Moderate)
9.6
7.1%
18.1
13.1%
Week 8 (4 - Severe)
4.4
3.3%
8.0
5.8%
Week 12 (0 - Clear)
11.9
8.8%
5.1
3.7%
Week 12 (1 - Almost clear)
54.8
40.6%
54.3
39.3%
Week 12 (2 - Mild)
24.4
18.1%
26.1
18.9%
Week 12 (3 - Moderate)
5.2
3.9%
8.0
5.8%
Week 12 (4 - Severe)
3.7
2.7%
6.5
4.7%
9. Secondary Outcome
Title Stinging/Burning Severity Score at Weeks 4, 8 and 12
Description The evaluator recorded the severity of the participant's facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort).
Time Frame Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Week 4
0.73
(0.79)
0.65
(0.75)
Week 8
0.41
(0.64)
0.44
(0.67)
Week 12
0.31
(0.55)
0.33
(0.63)
10. Secondary Outcome
Title Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12
Description The evaluator recorded the severity of the participant's facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort).
Time Frame Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Week 4 (0 - None)
47.4
35.1%
50.0
36.2%
Week 4 (1 - Mild)
32.6
24.1%
36.2
26.2%
Week 4 (2 - Moderate)
19.3
14.3%
12.3
8.9%
Week 4 (3 - Severe)
0.7
0.5%
1.4
1%
Week 8 (0 - None)
67.4
49.9%
64.5
46.7%
Week 8 (1 - Mild)
24.4
18.1%
28.3
20.5%
Week 8 (2 - Moderate)
8.1
6%
5.8
4.2%
Week 8 (3 - Severe)
0.0
0%
1.4
1%
Week 12 (0 - None)
73.3
54.3%
75.4
54.6%
Week 12 (1 - Mild)
22.2
16.4%
17.4
12.6%
Week 12 (2 - Moderate)
4.4
3.3%
6.5
4.7%
Week 12 (3 - Severe)
0.0
0%
0.0
0%
11. Secondary Outcome
Title Global Improvement Total Score at Week 12 (Last Visit/Early Termination)
Description Participants were evaluated for his/her improvement in rosacea compared to his/her rosacea condition before study, using global Improvement scale. It is a 7 item scale where, 0=complete improvement (all signs and symptoms of disease have resolved [100% improvement]); 1=excellent improvement (nearly all signs and symptoms cleared [90% improvement]. Only minimal residual signs and symptoms remain); 2=very good improvement (majority of the signs and symptoms have resolved [about 75% improvement]); 3=good improvement (significant improvement, but many signs and symptoms remain [about 50% improvement]); 4=minimal improvement (slight overall improvement, but not clinically significant [about 25% improvement]); 5=no change (overall severity similar to baseline); 6=worse (worse than baseline).
Time Frame Week 12 (last visit/early termination)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 126 129
Mean (Standard Deviation) [units on a scale]
1.79
(1.20)
1.81
(1.20)
12. Secondary Outcome
Title Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination)
Description Participants were to evaluated for his/her improvement in rosacea compared to his/her rosacea condition before study, using global Improvement scale. it is a 7 item scale where, 0=complete improvement (all signs and symptoms of disease have resolved [100% improvement]); 1=excellent improvement (nearly all signs and symptoms cleared [90% improvement]. Only minimal residual signs and symptoms remain); 2=very good improvement (majority of the signs and symptoms have resolved [about 75% improvement]); 3=good improvement (significant improvement, but many signs and symptoms remain [about 50% improvement]); 4=minimal improvement (slight overall improvement, but not clinically significant [about 25% improvement]); 5=no change (overall severity similar to baseline); 6=worse (worse than baseline). .
Time Frame Week 12 (last visit/early termination)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 126 129
0 - Complete improvement
7.9
5.9%
6.2
4.5%
1 - Excellent improvement
39.7
29.4%
44.2
32%
2 - Very good improvement
31.7
23.5%
25.6
18.6%
3 - Good improvement
11.9
8.8%
15.5
11.2%
4 - Minimal improvement
4.0
3%
3.9
2.8%
5 - No change
4.0
3%
3.9
2.8%
6 - Worse
0.8
0.6%
0.8
0.6%
13. Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE was any untoward medical occurrence that at any dose: results in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Time Frame From the signing of the informed consent form (ICF) up to Week 12

Outcome Measure Data

Analysis Population Description
Safety population (all participants treated [APT]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Adverse Events
27
20%
50
36.2%
Serious Adverse Events
1
0.7%
1
0.7%
14. Secondary Outcome
Title Dermatology Life Quality Index (DLQI) Questionnaire Total Score at Week 12 (Last Visit/Early Termination Visit)
Description DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of-life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0- 3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease.
Time Frame Week 12 (last visit/early termination)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 125 129
Mean (Standard Deviation) [units on a scale]
1.4
(2.2)
2.2
(4.0)
15. Secondary Outcome
Title Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category
Description Impact of study treatments on subjects' quality of life was measured by using DLQI questionnaire. DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of-life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0- 3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease.
Time Frame Baseline, Week 12 (last visit/early termination)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here, n, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Baseline: 0-1
17.8
13.2%
18.8
13.6%
Baseline: 2-5
37.8
28%
33.3
24.1%
Baseline: 6-10
27.4
20.3%
32.6
23.6%
Baseline: 11-20
14.8
11%
12.3
8.9%
Baseline: 21-30
2.2
1.6%
2.9
2.1%
Week 12: 0-1
68.0
50.4%
65.1
47.2%
Week 12: 2-5
26.4
19.6%
24.0
17.4%
Week 12: 6-10
4.8
3.6%
7.0
5.1%
Week 12: 11-20
0.8
0.6%
3.1
2.2%
Week 12: 21-30
0.0
0%
0.8
0.6%
16. Secondary Outcome
Title Percent Change From Baseline in Dermatology Life Quality Index Questionnaire Total Score at Week 12 (Last Visit/Early Termination)
Description Percent Change from Baseline in Dermatology Life Quality Index questionnaire Total Score at Last Visit. DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0-3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease.
Time Frame Baseline, Week 12 (last visit/early termination)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 120 126
Mean (Standard Deviation) [Percent Change]
-59.5
(66.3)
-59.2
(70.6)
17. Secondary Outcome
Title EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire at Week 12 (Last Visit/Early Termination Visit)
Description EQ-5D-5L is a 5-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprised of 5 levels with corresponding numeric scores, where 1 indicated no problems, and 5 indicated extreme problems. Participant selected answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-5L total score indicates improvement.
Time Frame Week 12/Last visit or early termination visit

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 125 129
Mean (Standard Deviation) [units on a scale]
83.5
(16.2)
83.0
(15.1)
18. Secondary Outcome
Title Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination)
Description EQ-5D-5L is a 5-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprised of 5 levels with corresponding numeric scores, where 1 indicated no problems, and 5 indicated extreme problems. Participant selected answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-5L total score indicates improvement.
Time Frame Baseline, Week 12 (last visit/early termination)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here, n, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 135 138
Baseline: Mobility
80
59.3%
84.1
60.9%
Baseline: Self-care
96.3
71.3%
97.8
70.9%
Baseline: Usual activities
85.9
63.6%
89.1
64.6%
Baseline: Pain/discomfort
55.6
41.2%
57.2
41.4%
Baseline: Anxiety/depression
65.9
48.8%
69.6
50.4%
Week 12: Mobility
80.0
59.3%
83.7
60.7%
Week 12: Self-care
94.4
69.9%
96.9
70.2%
Week 12: Usual activities
89.6
66.4%
90.7
65.7%
Week 12: Pain/discomfort
68.0
50.4%
79.1
57.3%
Week 12: Anxiety/depression
77.6
57.5%
82.2
59.6%
19. Secondary Outcome
Title Percentage of Participants Reported Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire for Currently Employed Question at Week 12 (Last Visit/Early Termination Visit)
Description WPAI:GH questionnaire was an instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. Currently Employed question was assessed in this outcome measure.
Time Frame Week 12 (Last visit/early termination visit)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 125 128
No
34.1
25.3%
34.8
25.2%
Yes
65.9
48.8%
65.2
47.2%
20. Secondary Outcome
Title Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire - Hours Missed at Work, Impact to Productivity at Work and Daily Activities at Week 12
Description WPAI:GH questionnaire is an instrument to measure impairment in both paid and unpaid work during the past week including questions: missed hours from work because of rosacea?, missed hours from work because of other reason?, number of Working hours. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.
Time Frame Week 12 (Last visit/Early termination visit)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 80 82
Missed hours from work because of rosacea
0.1
(0.9)
0.0
(0.0)
Missed hours from work because of other reason
4.2
(10.9)
2.9
(9.6)
Number of Working hours
36.3
(17.7)
38.2
(14.8)
21. Secondary Outcome
Title Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire (How Much Rosacea Affect Productivity at Work, How Much Rosacea Affect Daily Activity) at Week 12 (Last Visit/Early Termination Visit)
Description WPAI:GH questionnaire is an instrument to measure impairment in both paid and unpaid work during the past week, on a scale ranging from 0 (health problems had no effect) to 10 (health problems completely prevented them from working) including questions: 5) how much rosacea affect productivity at work?; 6) how much rosacea affect daily activity?. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicated little or no impact of health problems on work and activities, and a negative change in the WPAI score indicated improvement."
Time Frame Week 12 (Last visit/Early termination visit)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 125 128
How much rosacea affect productivity at work
0.6
(1.5)
0.5
(1.2)
How much rosacea affect daily activity
0.5
(1.3)
0.7
(1.5)
22. Secondary Outcome
Title Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A
Description Subject's satisfaction questionnaire was used to specifically collect the subjects' feedback on the treatment regimen, the level of satisfaction and future usage. Questionnaire consisted of 4 parts: Part A, B, C and D. where Part A consisted of following 12 questions about study drugs (capsules and cream): 1-Time the study regimen took to work, 2-Improvement of facial lesions, 3-Improvement of facial redness, 4-Improvement of ocular symptoms, 5-Improvement of flushing episodes, 6-How bothered by side effects, 7-Your face looks, 8-You feel, 9-Easy to incorporate in daily routine, 10-Using the study regimen again, 11-Overall satisfaction, 12-Compared to last treatment. Satisfied score of questionnaire meant as participants responded as Very satisfied (Questions-1,2,3,4,5,11), Not bothered at all (Question-6), A lot better (Questions- 7,8,12), yes (Question-10), strongly agree (Question-9).
Time Frame Week 12 (Last visit/early termination visit)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 125 129
1.Time the study regimen took to work
48.0
35.6%
45.0
32.6%
2.Improvement of facial lesions
48.0
35.6%
46.5
33.7%
3.Improvement of facial redness
45.6
33.8%
41.1
29.8%
4.Improvement of ocular symptoms
25.6
19%
26.4
19.1%
5.Improvement of flushing episodes
41.6
30.8%
38.0
27.5%
6.How bothered by side effects
84.0
62.2%
76.7
55.6%
7.Your face looks
70.4
52.1%
65.9
47.8%
8.You feel
61.6
45.6%
55.0
39.9%
9.Easy to incorporate in daily routine
62.4
46.2%
58.9
42.7%
10.Using the study regimen again
86.4
64%
82.9
60.1%
11.Overall satisfaction
54.4
40.3%
52.7
38.2%
12.Compared to last treatment
42.4
31.4%
41.1
29.8%
23. Secondary Outcome
Title Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B
Description Part B of Questionnaire consisted of following 10 questions about both provided skin care products cleanser and moisturizer: 1-Easy to incorporate into a daily routine, 2-Recommend to my family or friends, 3-Help my skin look healthier, 4-More confident with rosacea, 5-More confident with skin appearance, 6-Positive difference in the appearance, 7-Keep using both skin care products, 8-Make my skin more hydrated, 9-Improve the texture of my skin, 10-Pleasant to use.
Time Frame Week 12 (Last visit/early termination visit)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 124 129
1.Easy to incorporate into a daily routine
68.5
50.7%
70.5
51.1%
2.Recommend to my family or friends
60.5
44.8%
52.7
38.2%
3.Help my skin look healthier
58.1
43%
50.4
36.5%
4.More confident with rosacea
33.1
24.5%
32.6
23.6%
5.More confident with skin appearance
37.9
28.1%
36.4
26.4%
6.Positive difference in the appearance
47.6
35.3%
44.2
32%
7.Keep using both skin care products
52.4
38.8%
48.8
35.4%
8.Make my skin more hydrated
42.7
31.6%
38.8
28.1%
9.Improve the texture of my skin
35.5
26.3%
34.9
25.3%
10.Pleasant to use
54.0
40%
50.4
36.5%
24. Secondary Outcome
Title Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part C
Description Part C subject satisfaction questionnaire consisted of following 4 questions about the cosmetic product cleanser: 1-Clean healthy skin feeling, 2-Deep cleansing without stripping moisture, 3-Rinsed off easily, 4-Not make my skin feel tight or dry.
Time Frame Week 12 (Last visit or early termination visit)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 124 129
1.Clean healthy skin feeling
49.2
36.4%
46.5
33.7%
2.Deep cleansing without stripping moisture
41.1
30.4%
40.3
29.2%
3.Rinsed off easily
54.0
40%
48.8
35.4%
4.Not make my skin feel tight or dry
59.7
44.2%
50.4
36.5%
25. Secondary Outcome
Title Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part D
Description Part D of subject satisfaction questionnaire consisted of following 4 questions about the cosmetic product moisturizer: 1-Skin feel soft and smooth, 2-Improve my skin moisture, 3-Leave my skin hydrated and protected, 4-Provide comforting sensation.
Time Frame Week 12 (Last visit/early termination visit)

Outcome Measure Data

Analysis Population Description
ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Measure Participants 123 129
1.Skin feel soft and smooth
48.0
35.6%
35.7
25.9%
2.Improve my skin moisture
38.2
28.3%
34.1
24.7%
3.Leave my skin hydrated and protected
42.3
31.3%
38.0
27.5%
4.Provide comforting sensation
43.9
32.5%
37.2
27%

Adverse Events

Time Frame From the signing of the informed consent form (ICF) up to week 12
Adverse Event Reporting Description Safety population (all participants treated [APT]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Arm/Group Title Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Arm/Group Description Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
All Cause Mortality
Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/135 (0%) 0/138 (0%)
Serious Adverse Events
Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/135 (0.7%) 1/138 (0.7%)
Hepatobiliary disorders
Cholezystolithiasis 0/135 (0%) 0 1/138 (0.7%) 1
Musculoskeletal and connective tissue disorders
Multilevel discopathy in the cervical spine 1/135 (0.7%) 1 0/138 (0%) 0
Other (Not Including Serious) Adverse Events
Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 17/135 (12.6%) 33/138 (23.9%)
Gastrointestinal disorders
Diarrhoea 1/135 (0.7%) 1 6/138 (4.3%) 6
Nausea 0/135 (0%) 0 2/138 (1.4%) 2
Infections and infestations
Gastroenteritis 0/135 (0%) 0 3/138 (2.2%) 3
Nasopharyngitis 6/135 (4.4%) 6 10/138 (7.2%) 10
Rhinitis 0/135 (0%) 0 2/138 (1.4%) 2
Upper respiratory tract infection 2/135 (1.5%) 2 2/138 (1.4%) 2
Musculoskeletal and connective tissue disorders
Spinal pain 2/135 (1.5%) 2 0/138 (0%) 0
Nervous system disorders
Headache 3/135 (2.2%) 3 3/138 (2.2%) 4
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea 2/135 (1.5%) 2 1/138 (0.7%) 1
Skin and subcutaneous tissue disorders
Rosacea 1/135 (0.7%) 1 2/138 (1.4%) 2
Skin irritation 0/135 (0%) 0 2/138 (1.4%) 2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Rajeev Chavda
Organization Galderma
Phone 0033492382928
Email rajeev.chavda@galderma.com
Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT03075891
Other Study ID Numbers:
  • RD.03.SPR.113322
First Posted:
Mar 9, 2017
Last Update Posted:
Mar 16, 2021
Last Verified:
Nov 1, 2019