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

NCT02515305 | Completed Phase 3 Results

• 1 other identifier: PRG-NY-15-003
• Study Type: interventional
• Target: 890
• Locations: 1 country
• Sites: 1

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 acne vulgaris

Conditions

Acne

Outcome Measures

Primary Outcomes (2)

• Mean Percent Change From Baseline in Inflammatory (Papules and Pustules) Lesions

  Baseline to Day 84

• Mean Percent Change From Baseline in Non-inflammatory (Open and Closed Comedones) Lesions

  Baseline to Day 84

Study Arms (3)

Test product

EXPERIMENTAL

Drug: Clindamycin and Benzoyl Peroxide Gel (combination)

Reference product

ACTIVE COMPARATOR

Drug: Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)

Placebo product

PLACEBO COMPARATOR

Drug: Placebo gel (combination)

Interventions

Clindamycin and Benzoyl Peroxide Gel (combination) DRUG

Test product

Clindamycin and Benzoyl Peroxide Gel (Reference) (combination) DRUG

Reference product

Placebo gel (combination) 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:

• Provide written informed consent/assent
• Healthy male or non-pregnant females, 12 to 40 years of age, inclusive
• Definite clinical diagnosis of acne vulgaris with an inflammatory lesion (papules and pustules) count between 20 and 50 and a non-inflammatory (open and closed comedones) lesion count between 25 and 100 and no more than 2 nodulocystic lesions (i.e., nodules and cysts) including those present on the nose.
• Baseline IGA score of 3 or 4 on a scale of 0 to 4.
• Willing and able to understand and comply with the requirements of the study, apply the medication as instructed, refrain from use of all other topical acne medication or topical antibiotics during the 12-week treatment period, return for the required treatment period visits, comply with therapy prohibitions, and are able to complete the study.
• Be in general good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
• Females of childbearing potential willing to use an acceptable form of birth control

You may not qualify if:

• Females who are pregnant, nursing, or planning a pregnancy within the study participation period
• More than 2 facial nodulocystic lesions (i.e. nodules and cysts).
• Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.).
• Active cystic acne or Polycystic Ovarian Syndrome.
• History or presence of Crohn's disease, ulcerative colitis, regional enteritis, inflammatory bowel disease, pseudomembranous colitis, chronic or recurrent diarrhea or antibiotic-associated colitis.
• Use of neuromuscular blocking agents (nondepolarizing agents and depolarizing agents) Subjects who have had general anesthesia for any reason and subjects who have received neuromuscular blocking agents within 14 days prior to study entry will be excluded from study participation.
• Presence of any other facial skin condition that might interfere with acne vulgaris diagnosis and/or assessment (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, sunburn or bacterial folliculitis).
• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
• History of unresponsiveness to topical Clindamycin Phosphate and/or benzoyl peroxide therapy.
• Use of systemic Clindamycin products 4 weeks (30 days) prior to baseline or throughout the study.
• History of hypersensitivity or allergy to Clindamycin Phosphate, benzoyl peroxide and/or any ingredient in the study medication.
• Use within 6 months (180 days) 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 of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline).
• Use within 30 days (1 month) prior to baseline or during the study of therapeutic vitamin D supplement (daily multivitamins with total 800IU Vitamin D are allowed).
• Use of medications known to exacerbate acne (Vitamin B12, lithium, corticosteroids; Vitamin B12, etc. as part of a multivitamin regimen is allowed).

Sponsors & Collaborators

• Padagis LLC: lead

Study Sites (1)

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

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: July 31, 2015
• First Posted: August 4, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 8, 2021
• Results First Posted: November 16, 2020

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)