A Study to Compare Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% to Acanya® Topical Gel in the Treatment of Acne Vulgaris

NCT01796665 | Completed Phase 3 Results

• 1 other identifier: PRG-NY-12-005
• Study Type: interventional
• Target: 1,180
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study was to evaluate the efficacy and safety of Perrigo's test formulation of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% compared to the already marketed formulation, Acanya gel in patients with acne vulgaris.

Conditions

Acne

Outcome Measures

Primary Outcomes (2)

• Mean Percent Change in the Inflammatory (Papules and Pustules) Lesion Count

  Per protocol population

  Baseline to week 12

• Mean Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Count

  Baseline to week 12

Secondary Outcomes (1)

• Clinical Success on Investigator's Global Evaluation

  Baseline to week 12

Study Arms (3)

Test product

EXPERIMENTAL

Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.

Drug: Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%

Reference product

ACTIVE COMPARATOR

Acanya Gel applied to the affected areas of the face once daily.

Drug: Acanya Gel

Placebo product

PLACEBO COMPARATOR

Placebo of the Test product applied to the affected areas of the face once daily.

Drug: Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product

Interventions

Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% DRUG

Also known as: Test product

Test product

Acanya Gel DRUG

Also known as: Reference product

Reference product

Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product DRUG

Also known as: Placebo product

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:

• Subject and/or parent or legally authorized representative must sign an Institutional Review Board (IRB) approved written informed consent/assent.
• Male or female, 12 to 40 years of age, inclusive.
• Definite clinical diagnosis of facial 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 Investigator's Global Assessment Score of 3 (moderate severity) or 4 (severe) on a severity 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.
• 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 (excluding women who are surgically sterilized or post menopausal for at least 2 years), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: Oral Contraceptives, Contraceptive patches, Contraceptive Injection (Depo-Provera), Contraceptive Implant (Implanon), Vaginal Contraceptive (Nuva-Ring), IUD, hormonal IUD (Mirena); double-barrier methods (e.g. condom and spermicide) and abstinence with a documented second acceptable method of birth control should subject become sexually active. A sterile sexual partner is not considered an adequate form of birth control. Subjects entering the trial that are on hormonal contraceptives must have been on this method for at least 3 months (90 days) prior to the trial and continue the method for the duration of the trial. Subjects who had used hormonal contraception and stopped must have stopped no less than 3 months (90 days) prior to baseline.

You may not qualify if:

• Pregnant, breast feeding, 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, or antibiotic-associated colitis.
• Use of neuromuscular blocking agents (nondepolarizing agents and depolarizing agents)
• 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, 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 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 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 30 days 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).
• Start or change of dose of hormonal treatment (oral, implanted, topical contraceptives and androgens) 3 months prior to base-line or throughout the study. Use of such therapy must remain constant during the study.

Sponsors & Collaborators

• Padagis LLC: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate; Acanya Gel; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

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

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: February 18, 2013
• First Posted: February 22, 2013
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 22, 2021
• Results First Posted: January 20, 2021

Record last verified: 2021-10