Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris

The purpose of this study is to compare the safety and bioequivalence of Perrigo's product to an FDA approved product for the treatment acne vulgaris.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: Adapalene and Benzoyl Peroxide Gel; Drug: Adapalene and Benzoyl Peroxide Gel (Reference); Drug: Placebo gel

• Study Type: Interventional
• Enrollment (Actual): 903
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and non-pregnant female subjects, 12 to 40 years of age (inclusive), with a clinical diagnosis of at least moderate facial acne vulgaris
• Inflammatory lesion (papules and pustules) count of 20 to 50 (inclusive)
• Non-inflammatory (open and closed comedones) lesion count of 25 to 100 (inclusive)
• No more than two nodulocystic lesions (i.e., nodules and cysts) on the face including those present on the nose, were enrolled.
• Subjects must also have had a Baseline IGA score of 3 or 4 on a severity scale of 0 to 4 to be enrolled.

Exclusion Criteria:

• Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
• Presence of more than 2 facial Nodulocystic lesions (i.e. nodules and cysts)
• Subjects with active cystic acne or Polycystic Ovarian Syndrome
• Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations (e .g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculiti s).
• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
• Acne conglobata, acne fulminan s, or secondary acne (chloracne, drug-induced acne, etc.)
• Use of antipruritics including antihistamine, within 24 hours prior to all study visits (Visit l/Baseline through Visit 4).
• Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days of study entry and throughout the study (other than study supplied cleanser and lotion).
• Use within 6 months prior to baseline or during the study of oral retinoids (e.g. Accutane"') or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
• Use within 1 month prior to baseline or during the study of therapeutic vitamin D supplement (multivitamins are allowed).
• Use within 1 month prior to baseline or during the study of 1) systemic sterOids', 2) systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout), or 4) systemic anti-inflammatory agents". (' Intranasal and inhaled corticosteroids do not require a washout and may be used throughout the study if at a stable and standard dose. "Subjects may use Acetaminophen for pain relief, as needed, throughout the study)
• Use within 14 days prior to baseline or during the study of 1) topical sterOids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparation (e.g. azelaic acid,etc.) 4)a-hydroxy/glycolic acid, 5) benzoyl peroxide, 6) topical anti-inflammatory agents, or 7) topical antibiotics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test product; Adapalene and Benzoyl Peroxide Gel	Drug: Adapalene and Benzoyl Peroxide Gel
Active Comparator: Reference product; Adapalene and Benzoyl Peroxide Gel (Reference)	Drug: Adapalene and Benzoyl Peroxide Gel (Reference)
Placebo Comparator: Placebo product; Placebo gel	Drug: Placebo gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions	84 days
Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions	84 days

Collaborators and Investigators

• Sponsor: Padagis LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: August 14, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Benzoyl Peroxide; Adapalene
• Other Study ID Numbers: PRG-817