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

NCT03393494 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PRG-NY-17-008
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Mean Percent Change From Baseline in the Papules and Pustules Lesion Count

  Day 1 to week 12

• Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count

  Per protocol population

  Day 1 to week 12

Study Arms (3)

Perrigo active

EXPERIMENTAL

Test product

Drug: Adapalene and Benzoyl Peroxide Topical Gel

Reference active

ACTIVE COMPARATOR

RLD product

Drug: Epiduo Topical Product

Perrigo placebo

PLACEBO COMPARATOR

placebo product

Drug: Placebo

Interventions

Adapalene and Benzoyl Peroxide Topical Gel DRUG

Test product

Perrigo active

Epiduo Topical Product DRUG

RLD product

Reference active

Placebo DRUG

Placebo gel

Perrigo placebo

Eligibility Criteria

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

You may qualify if:

• Signed IRB approved written informed consent/assent
• to 40 years of age, inclusive.
• 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.
• Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.
• 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.

You may not qualify if:

• Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
• Presence of more than 2 facial Nodulocystic lesions.
• Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations
• 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
• Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris.
• History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.
• Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family.
• History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication.
• Use of medications known to exacerbate acne
• Start or change within 3 months (90 days) of Visit 1 and throughout the study
• 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
• Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
• Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.

Sponsors & Collaborators

• Padagis LLC: lead

Study Sites (1)

Dermatology Consultants

High Point, North Carolina, 27262, United States

Location

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: January 3, 2018
• First Posted: January 8, 2018
• Study Start: December 13, 2017
• Primary Completion: September 30, 2018
• Study Completion: January 5, 2019
• Last Updated: November 8, 2021
• Results First Posted: January 5, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)