Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03393494
• Collaborator: (none)
• Enrollment: 825
• Location: 1
• Arms: 3
• Actual Duration (Months): 12.7
• Patients Per Site Per Month: 64.7

Study Details

Study Description

Brief Summary

To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Adapalene and Benzoyl Peroxide Topical Gel; Drug: Epiduo Topical Product; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 825 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Adapalene/BP Gel to Galderma's Epiduo (Adapalene/BP) Gel, and Both Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
• Actual Study Start Date: Dec 13, 2017
• Actual Primary Completion Date: Sep 30, 2018
• Actual Study Completion Date: Jan 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Perrigo active Test product	Drug: Adapalene and Benzoyl Peroxide Topical Gel; Test product
Active Comparator: Reference active RLD product	Drug: Epiduo Topical Product; RLD product
Placebo Comparator: Perrigo placebo placebo product	Drug: Placebo; Placebo gel

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change From Baseline in the Papules and Pustules Lesion Count [Day 1 to week 12]

2. Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count [Day 1 to week 12]

   Per protocol population

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Signed IRB approved written informed consent/assent

2. 12 to 40 years of age, inclusive.

3. Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose.

4. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.

5. Females of child bearing potential (excluding women who are surgically sterilized (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/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.

Exclusion Criteria:

1. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.

2. Presence of more than 2 facial Nodulocystic lesions.

3. Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations

4. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments

5. Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris.

6. History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.

7. Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family.

8. History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication.

9. Use of medications known to exacerbate acne

10. Start or change within 3 months (90 days) of Visit 1 and throughout the study

11. Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study

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

13. 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

	Site	City	State	Country	Postal Code
1	Dermatology Consultants	High Point	North Carolina	United States	27262

Sponsors and Collaborators

• Padagis LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Sep 28, 2017
• Statistical Analysis Plan - Sep 28, 2017

More Information

Publications

None provided.

• Responsible Party: Padagis LLC
• ClinicalTrials.gov Identifier: NCT03393494
• Other Study ID Numbers: PRG-NY-17-008
• First Posted: Jan 8, 2018
• Last Update Posted: Nov 8, 2021
• Last Verified: Nov 1, 2021

• 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.: No
• Additional relevant MeSH terms: Acne Vulgaris; Adapalene; Benzoyl Peroxide

Study Results

Participant Flow

Arm/Group Title	Test Product	Reference Product	Placebo Product
Arm/Group Description	Adapalene and Benzoyl Peroxide Topical Gel	Epiduo Topical Gel	Placebo gel
Period Title: Overall Study
STARTED	329	331	165
COMPLETED	261	256	140
NOT COMPLETED	68	75	25

Baseline Characteristics

Arm/Group Title	Perrigo Active	Reference Active	Perrigo Placebo	Total
Arm/Group Description	Test product Adapalene and Benzoyl Peroxide Topical Gel: Test product	RLD product Epiduo Topical Product: RLD product	placebo product Placebo: Placebo gel	Total of all reporting groups
Overall Participants	329	331	165	825
Age (Count of Participants)
<=18 years	160 48.6%	161 48.6%	76 46.1%	397 48.1%
Between 18 and 65 years	169 51.4%	170 51.4%	89 53.9%	428 51.9%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	117 35.6%	129 39%	69 41.8%	315 38.2%
Male	212 64.4%	202 61%	96 58.2%	510 61.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	126 38.3%	120 36.3%	53 32.1%	299 36.2%
Not Hispanic or Latino	203 61.7%	211 63.7%	112 67.9%	526 63.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.6%	2 0.6%	0 0%	4 0.5%
Asian	13 4%	6 1.8%	4 2.4%	23 2.8%
Native Hawaiian or Other Pacific Islander	1 0.3%	0 0%	0 0%	1 0.1%
Black or African American	51 15.5%	48 14.5%	30 18.2%	129 15.6%
White	241 73.3%	256 77.3%	122 73.9%	619 75%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	21 6.4%	19 5.7%	9 5.5%	49 5.9%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change From Baseline in the Papules and Pustules Lesion Count
Time Frame	Day 1 to week 12

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	Perrigo Active	Reference Active	Perrigo Placebo
Arm/Group Description	Test product Adapalene and Benzoyl Peroxide Topical Gel: Test product	RLD product Epiduo Topical Product: RLD product	placebo product Placebo: Placebo gel
Measure Participants	202	218	120
Mean (Standard Deviation) [percentage of lesion change]	68.18 (28.96)	63.56 (31.57)	50.72 (35.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Perrigo Active, Reference Active
	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	107
	Confidence Interval	(2-Sided) 90%; 97.8 to 112.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count
Description	Per protocol population
Time Frame	Day 1 to week 12

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	Perrigo Active	Reference Active	Perrigo Placebo
Arm/Group Description	Test product Adapalene and Benzoyl Peroxide Topical Gel: Test product	RLD product Epiduo Topical Product: RLD product	placebo product Placebo: Placebo gel
Measure Participants	202	218	120
Mean (Standard Deviation) [percentage of lesion change]	62.75 (28.09)	60.78 (33.73)	43.45 (36.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Perrigo Active, Reference Active
	Comments
	Type of Statistical Test	Equivalence
	Comments	provides 85% power of success
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Fieller's method
	Comments
Method of Estimation	Estimation Parameter	Equivalence ratio
	Estimated Value	104
	Confidence Interval	(2-Sided) 90%; 94.1 to 108.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	12 Weeks
Arm/Group Title	Perrigo Active		Reference Active		Perrigo Placebo
Arm/Group Description	Test product Adapalene and Benzoyl Peroxide Topical Gel: Test product		RLD product Epiduo Topical Product: RLD product		placebo product Placebo: Placebo gel
All Cause Mortality
	Perrigo Active		Reference Active		Perrigo Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/329 (0%)		0/331 (0%)		0/165 (0%)
Serious Adverse Events
	Perrigo Active		Reference Active		Perrigo Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/329 (0%)		0/331 (0%)		2/165 (1.2%)
Nervous system disorders
Cervical Radiculopathy	0/329 (0%)	0	0/331 (0%)	0	1/165 (0.6%)	1
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/329 (0%)	0	0/331 (0%)	0	1/165 (0.6%)	1
Other (Not Including Serious) Adverse Events
	Perrigo Active		Reference Active		Perrigo Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/329 (0%)		0/331 (0%)		0/165 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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