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

NCT02525549 | Completed Phase 3 Results

• 1 other identifier: PRG-817
• Study Type: interventional
• Target: 903
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Test product

EXPERIMENTAL

Adapalene and Benzoyl Peroxide Gel

Drug: Adapalene and Benzoyl Peroxide Gel

Reference product

ACTIVE COMPARATOR

Adapalene and Benzoyl Peroxide Gel (Reference)

Drug: Adapalene and Benzoyl Peroxide Gel (Reference)

Placebo product

PLACEBO COMPARATOR

Placebo gel

Drug: Placebo gel

Interventions

Adapalene and Benzoyl Peroxide Gel DRUG

Test product

Adapalene and Benzoyl Peroxide Gel (Reference) DRUG

Reference product

Placebo gel DRUG

Placebo product

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Padagis LLC: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Jonathan Schwartz
• Organization: Perrigo

jonathan.schwartz@perrigo.com

718-960-9900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 17, 2015
• Study Start: December 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 2, 2021
• Results First Posted: January 20, 2021

Record last verified: 2021-10