Comparative Safety and Efficacy of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02795117
• Collaborator: (none)
• Enrollment: 486
• Arms: 3
• Actual Duration (Months): 9.1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of inflammatory lesions rosacea

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: Ivermectin; Drug: Ivermectin (reference); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 486 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test product	Drug: Ivermectin
Active Comparator: Reference product	Drug: Ivermectin (reference)
Placebo Comparator: Placebo product	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count [Day 1 to Day 84]

Secondary Outcome Measures

1. Subjects With Clinical Success on the Investigator Global Assessment [Day 1 to Day 84]

   Clinical success is defined as a score of clear or almost clear

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Must sign an Institutional Review Board (IRB) approved written informed consent for this study.

2. Must be at least 18 years of age

3. Must have a definite clinical diagnosis of moderate to severe facial papulopustular rosacea

4. Subjects must be willing and able to understand and comply with the requirements of the study and apply the medication as instructed.

5. Subjects must be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations.

6. Females of childbearing potential (excluding women who are surgically sterilized (verified tubal ligation or bilateral oophorectomy or hysterectomy) or post- menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1 (Baseline), must be willing to use an acceptable form of birth control during the study.

Exclusion Criteria:

1. Subjects, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.

2. Current or past ocular rosacea.

3. Presence of any other facial skin condition that might interfere with rosacea diagnosis and/or assessment.

4. History of hypersensitivity or allergy to the study medication and/or any ingredient in the study medication.

5. Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline).

6. Current use of anticoagulation therapy and use throughout the study.

7. Use of medicated make-up (including anti-aging make-up) throughout the study

8. Use during the study of 1) systemic steroids, 2) topical retinoids to the face 3) antibiotics known to impact rosacea 4) immunosuppressive agents, or immunomodulators).

9. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics.

10. Use of medicated cleansers on the face (throughout the study.

11. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements

12. Use of topical astringents or abrasives, medicated topical preparations (prescription and OTC products) within 2 days prior to Visit 1 and throughout the study.

13. Use of antipruritics (including antihistamines), spa treatments or chlorine exposure (swimming etc.) within 24 hours of all study visits.

14. Participation in any clinical study involving an investigational product, agent or device that might influence the intended effects or mask the side effects of study medication in the 1 month (30 days) prior Visit 1/Day 1 (Baseline) or throughout the study.

15. Previous enrollment in this study or current enrollment in this study at another participating site.

16. Use of tanning booths, sun lamps (excessive UV radiation e.g., phototherapy, daily extended exposure or occupational exposure to the sun), sunbathing or excessive exposure to the sun 1 week prior to baseline and throughout the study.

17. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Padagis LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Apr 27, 2016
• Statistical Analysis Plan - Apr 27, 2016

More Information

Publications

None provided.

• Responsible Party: Padagis LLC
• ClinicalTrials.gov Identifier: NCT02795117
• Other Study ID Numbers: PRG-NY-15-013
• First Posted: Jun 9, 2016
• Last Update Posted: Nov 2, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Rosacea; Ivermectin

Study Results

Participant Flow

Arm/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	Ivermectin cream	Ivermectin (reference) cream	Placebo cream
Period Title: Overall Study
STARTED	193	193	100
COMPLETED	175	166	88
NOT COMPLETED	18	27	12

Baseline Characteristics

Arm/Group Title	Test Product	Reference Product	Placebo	Total
Arm/Group Description	Ivermectin Cream, 1% (Perrigo)	Ivermectin Cream, 1% (reference)	Placebo cream	Total of all reporting groups
Overall Participants	193	193	100	486
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.9 (12.65)	51.3 (13.61)	51.2 (14.25)	51.5 (13.35)
Sex: Female, Male (Count of Participants)
Female	141 73.1%	140 72.5%	67 67%	348 71.6%
Male	52 26.9%	53 27.5%	33 33%	138 28.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	38 19.7%	37 19.2%	19 19%	94 19.3%
Not Hispanic or Latino	155 80.3%	156 80.8%	81 81%	392 80.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	1 1%	1 0.2%
Asian	3 1.6%	2 1%	0 0%	5 1%
Native Hawaiian or Other Pacific Islander	1 0.5%	1 0.5%	0 0%	2 0.4%
Black or African American	0 0%	0 0%	2 2%	2 0.4%
White	188 97.4%	189 97.9%	97 97%	474 97.5%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 0.5%	1 0.5%	0 0%	2 0.4%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count
Time Frame	Day 1 to Day 84

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	Ivermectin cream	Ivermectin (reference) cream	Placebo cream
Measure Participants	156	147	75
Mean (Standard Deviation) [percentage of lesion reduction]	65.47 (30.222)	67.89 (30.244)	55.51 (32.660)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Product, Reference Product
	Comments
	Type of Statistical Test	Equivalence
	Comments	provides 85% power of success
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	equivalence ratio
	Estimated Value	96.4
	Confidence Interval	(2-Sided) 90%; 91.0 to 105.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Subjects With Clinical Success on the Investigator Global Assessment
Description	Clinical success is defined as a score of clear or almost clear
Time Frame	Day 1 to Day 84

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	Ivermectin cream	Ivermectin (reference) cream	Placebo cream
Measure Participants	156	147	75
Count of Participants [Participants]	71 36.8%	79 40.9%	26 26%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Product, Reference Product
	Comments
	Type of Statistical Test	Equivalence
	Comments	provides 85% power of success
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Equivalence difference
	Estimated Value	-6.48
	Confidence Interval	(2-Sided) 90%; -18.31 to 1.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Day 1 to day 84
Arm/Group Title	Test Product		Reference Product		Placebo
Arm/Group Description	Ivermectin cream		Ivermectin (reference) cream		Placebo cream
All Cause Mortality
	Test Product		Reference Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/193 (0%)		0/193 (0%)		0/100 (0%)
Serious Adverse Events
	Test Product		Reference Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/193 (0%)		0/193 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	Test Product		Reference Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/193 (0%)		0/193 (0%)		0/100 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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