A Pilot Study on the Use of Seysara for Rosacea

• Sponsor: Derm Research, PLLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT04555525
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.6
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

This is a prospective, parallel group, randomized, investigator-blinded pilot study. Approximately 100 subjects will be randomized at a 3:1 ratio to Seysara (sarecycline) at a weight-based dose per label or Centrum Adult Multivitamin to take by mouth daily. The study is comprised of 5 visits: screening, baseline, week 4, week 8, and week 12. Investigators will perform rosacea IGA (Investigator Global Assessment,) inflammatory lesion count, record adverse events and con meds, and ask each subject to complete a DLQI (Dermatology Life Quality Index.)

Condition or Disease	Intervention/Treatment	Phase
Acne Rosacea	Drug: sarecycline; Dietary Supplement: Centrum Adult Multivitamin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Pilot Study on the Use of Seysara for Rosacea
• Actual Study Start Date: Apr 15, 2019
• Actual Primary Completion Date: Sep 23, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sarecycline weight-based dose per label by mouth once daily for 12 weeks	Drug: sarecycline; sarecycline tablet; Other Names: Seysara sarecycline hydrochloride
Other: Centrum Adult Multivitamin one tablet by mouth daily for 12 weeks	Dietary Supplement: Centrum Adult Multivitamin; Centrum Adult Mulltivitamin tablet

Outcome Measures

Primary Outcome Measures

1. IGA (Investigator Global Assessment) [12 weeks]

   Percent of subjects achieving clear or almost clear on IGA. The Investigator will score rosacea at each visit as per the following IGA: 0 = Clear (No inflammatory lesions present, no erythema); 1 = Almost Clear (Very few small papules/pustules, very mild erythema present); 2 Mild (Few small or large papules/pustules, moderate erythema); 3= Moderate (Several small or large papules/pustules, moderate erythema); 4 = Severe (Numerous small and/or large papules/pustules, severe erythema)

2. Inflammatory Lesion Count [Baseline and 12 weeks]

   Change in inflammatory lesion count

Secondary Outcome Measures

1. IGA [week 4]

   Percent of subjects achieving clear or almost clear on IGA. The Investigator will score rosacea at each visit as per the following IGA: 0 = Clear (No inflammatory lesions present, no erythema); 1 = Almost Clear (Very few small papules/pustules, very mild erythema present); 2 Mild (Few small or large papules/pustules, moderate erythema); 3= Moderate (Several small or large papules/pustules, moderate erythema); 4 = Severe (Numerous small and/or large papules/pustules, severe erythema)

2. IGA [week 8]

   Percent of subjects achieving clear or almost clear on IGA. The Investigator will score rosacea at each visit as per the following IGA: 0 = Clear (No inflammatory lesions present, no erythema); 1 = Almost Clear (Very few small papules/pustules, very mild erythema present); 2 Mild (Few small or large papules/pustules, moderate erythema); 3= Moderate (Several small or large papules/pustules, moderate erythema); 4 = Severe (Numerous small and/or large papules/pustules, severe erythema)

3. Inflammatory Lesion Count [Baseline and Week 4]

   Change in inflammatory lesion count

4. Inflammatory Lesion Count [Baseline and Week 8]

   Change in inflammatory lesion count

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Male or female ≥18 years of age

2. Moderate to severe rosacea (IGA score 3 or 4) on the proposed facial treatment area consisting of:

3. At least 15 and not more than 50 facial papules and pustules, excluding lesions involving the eyes and scalp

4. No more than 2 nodules on the face

5. Presence or history of erythema and/or flushing of the face

6. If a female of child-bearing potential, have a negative urine pregnancy test and agree to use an effective method of contraception. A sterile sexual partner is NOT considered an adequate form of birth control

7. Willing to minimize external factors that might trigger rosacea flare-ups (eg, spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds, and alcoholic beverages

8. Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to use the same make-up, brand/type, or frequency of use throughout the study

9. Completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures -

Exclusion Criteria:

1. Woman who is pregnant, lactating, or planning to become pregnant during the study period

2. presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea

3. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe;) or plaque-like facial edema

4. Excessive facial hair (eg, beards, sideburns, moustaches, etc) that would interfere with diagnosis or assessment of rosacea

5. History of hypersensitivity or allergy to all tetracyclines, or to any other component of the formulation

6. Patients with history of C-diff associated colitis, intracranial hypertension will be excluded

7. Severe erythema, dryness, scaling, pruritis, stinging/burning, or edema

8. Use within 6 months prior to Day 0/Baseline of oral retinoids (eg, Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed)

9. Initiation of use of estrogens or oral contraceptives less than 3 months prior to Day 0/Baseline

10. Use within 1 month prior to Day 0/Baseline of:

11. Systemic antibiotics known to have an impact on the severity of facial rosacea (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim.) Subjects requiring systemic antibiotics not known to affect rosacea will be considered on a case-by-case basis

12. Systemic corticosteroids (Note: intranasal and inhalational corticosteroids do not require a washout and maybe used throughout the trial if the subject is on a stable dose.)

13. Use within 2 weeks prior to Day 0/Baseline of:

14. Topical corticosteroids

15. Topical antibiotics

16. Topical medications for rosacea (eg, metronidazole)

17. Use of sauna during the 2 weeks prior to Day 0/Baseline and during the study

18. Had wax epilation of the face within 2 weeks prior to Day 0/Baseline

19. Active bacterial folliculitis

20. Consumption of excessive alcohol, abuse of licit or illicit drugs, or a condition that, in the opinion of the Investigator, could compromise the subject's ability to comply with study requirements

21. Participation in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold

22. Presence of any clinically significant condition or situation, other than the condition being studied, that in the opinion of the Investigator would interfere with the study evaluations or optimal participation in the study

23. Participation in an investigational drug study (ie, subject has been treated with an investigational drug) within 30 days prior to Day 0/Baseline. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion

24. Prior laser therapy (for telangiectasia or other conditions), electrodessication, or phototherapy (eg, ClearLight ®) to the facial area within 180 days prior to Day 0/Baseline

25. Prior cosmetic procedures (eg, facials) that may affect the efficacy and safety profile of the investigational product within 14 days prior to Day 0/Baseline

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skin Sciences, PLLC	Louisville	Kentucky	United States	40217

Sponsors and Collaborators

• Derm Research, PLLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 19, 2019

More Information

Publications

None provided.

• Responsible Party: L.H. Kircik, M.D., Medical Director, Derm Research, PLLC
• ClinicalTrials.gov Identifier: NCT04555525
• Other Study ID Numbers: SEY1901
• First Posted: Sep 18, 2020
• Last Update Posted: Jan 7, 2021
• Last Verified: Dec 1, 2020

• 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
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Rosacea; Sarecycline

Study Results

Participant Flow

Arm/Group Title	Sarecycline	Centrum Adult Multivitamin
Arm/Group Description	weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Period Title: Overall Study
STARTED	75	25
COMPLETED	72	25
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Sarecycline	Centrum Adult Multivitamin	Total
Arm/Group Description	weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet	Total of all reporting groups
Overall Participants	72	25	97
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.42 (14.96)	52.36 (13.47)	52.41 (14.52)
Sex: Female, Male (Count of Participants)
Female	58 80.6%	22 88%	80 82.5%
Male	14 19.4%	3 12%	17 17.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.4%	0 0%	1 1%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 2.8%	0 0%	2 2.1%
White	69 95.8%	25 100%	94 96.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	72 100%	25 100%	97 100%

Outcome Measures

1. Primary Outcome

Title	IGA (Investigator Global Assessment)
Description	Percent of subjects achieving clear or almost clear on IGA. The Investigator will score rosacea at each visit as per the following IGA: 0 = Clear (No inflammatory lesions present, no erythema); 1 = Almost Clear (Very few small papules/pustules, very mild erythema present); 2 Mild (Few small or large papules/pustules, moderate erythema); 3= Moderate (Several small or large papules/pustules, moderate erythema); 4 = Severe (Numerous small and/or large papules/pustules, severe erythema)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sarecycline	Centrum Adult Multivitamin
Arm/Group Description	weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Measure Participants	72	25
Count of Participants [Participants]	54 75%	4 16%

2. Primary Outcome

Title	Inflammatory Lesion Count
Description	Change in inflammatory lesion count
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sarecycline	Centrum Adult Multivitamin
Arm/Group Description	weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Measure Participants	72	25
Mean (Standard Deviation) [Percent Change]	-80 (24)	-60 (32)

3. Secondary Outcome

Title	IGA
Description	Percent of subjects achieving clear or almost clear on IGA. The Investigator will score rosacea at each visit as per the following IGA: 0 = Clear (No inflammatory lesions present, no erythema); 1 = Almost Clear (Very few small papules/pustules, very mild erythema present); 2 Mild (Few small or large papules/pustules, moderate erythema); 3= Moderate (Several small or large papules/pustules, moderate erythema); 4 = Severe (Numerous small and/or large papules/pustules, severe erythema)
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sarecycline	Centrum Adult Multivitamin
Arm/Group Description	weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Measure Participants	72	25
Count of Participants [Participants]	15 20.8%	2 8%

4. Secondary Outcome

Title	IGA
Description	Percent of subjects achieving clear or almost clear on IGA. The Investigator will score rosacea at each visit as per the following IGA: 0 = Clear (No inflammatory lesions present, no erythema); 1 = Almost Clear (Very few small papules/pustules, very mild erythema present); 2 Mild (Few small or large papules/pustules, moderate erythema); 3= Moderate (Several small or large papules/pustules, moderate erythema); 4 = Severe (Numerous small and/or large papules/pustules, severe erythema)
Time Frame	week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sarecycline	Centrum Adult Multivitamin
Arm/Group Description	weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Measure Participants	72	25
Count of Participants [Participants]	32 44.4%	3 12%

5. Secondary Outcome

Title	Inflammatory Lesion Count
Description	Change in inflammatory lesion count
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sarecycline	Centrum Adult Multivitamin
Arm/Group Description	weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Measure Participants	72	25
Mean (Standard Deviation) [Percent Change]	-56 (29)	-31 (30)

6. Secondary Outcome

Title	Inflammatory Lesion Count
Description	Change in inflammatory lesion count
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sarecycline	Centrum Adult Multivitamin
Arm/Group Description	weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet	one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
Measure Participants	72	25
Mean (Standard Deviation) [Percent Change]	-71 (27)	-44 (42)

Adverse Events

Time Frame	12 weeks average, from signing of Informed Consent until end of study participation.
Arm/Group Title	Sarecycline		Centrum Adult Multivitamin
Arm/Group Description	weight-based dose per label by mouth once daily for 12 weeks sarecycline: sarecycline tablet		one tablet by mouth daily for 12 weeks Centrum Adult Multivitamin: Centrum Adult Mulltivitamin tablet
All Cause Mortality
	Sarecycline		Centrum Adult Multivitamin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/25 (0%)
Serious Adverse Events
	Sarecycline		Centrum Adult Multivitamin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Sarecycline		Centrum Adult Multivitamin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/72 (22.2%)		0/25 (0%)
Ear and labyrinth disorders
r ear infection	1/72 (1.4%)	1	0/25 (0%)	1
Gastrointestinal disorders
gastroenteritis	1/72 (1.4%)	1	0/25 (0%)	1
metallic taste	1/72 (1.4%)	1	0/25 (0%)	1
nausea	1/72 (1.4%)	1	0/25 (0%)	1
stomach bloating	1/72 (1.4%)	1	0/25 (0%)	1
Hepatobiliary disorders
cholelithiasis worsening	1/72 (1.4%)	1	0/25 (0%)	1
Infections and infestations
herpes simplex l lower lip	1/72 (1.4%)	1	0/25 (0%)	1
influenza	1/72 (1.4%)	1	0/25 (0%)	1
respiratory syncytial virus	1/72 (1.4%)	1	0/25 (0%)	1
sinus infection	1/72 (1.4%)	1	0/25 (0%)	1
tinea versicolor	1/72 (1.4%)	1	0/25 (0%)	1
Musculoskeletal and connective tissue disorders
bone spur	1/72 (1.4%)	1	0/25 (0%)	1
generalized muscle soreness	1/72 (1.4%)	1	0/25 (0%)	1
intermittent pain under r rib cage	1/72 (1.4%)	1	0/25 (0%)	1
Nervous system disorders
headache	2/72 (2.8%)	2	0/25 (0%)	2
sleep apnea	1/72 (1.4%)	1	0/25 (0%)	1
Skin and subcutaneous tissue disorders
Boil	1/72 (1.4%)	1	0/25 (0%)	1
dry lips	1/72 (1.4%)	1	0/25 (0%)	1
facial sunburn	1/72 (1.4%)	1	0/25 (0%)	1
dog bite r arm	1/72 (1.4%)	1	0/25 (0%)	1
ingrown eyebrow hair	1/72 (1.4%)	1	0/25 (0%)	1
rash of unknown origin	1/72 (1.4%)	1	0/25 (0%)	1
sunburn on face	1/72 (1.4%)	1	0/25 (0%)	1
Surgical and medical procedures
cholecystectomy	1/72 (1.4%)	1	0/25 (0%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.