Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris

NCT02709902 — Phase 1, Completed, 460 participants, Sun Pharmaceutical Industries, Inc.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Multi-center, Double-blind, Randomized, Placebo, Controlled, Parallel-group Study, Comparing Adapalene/BP Gel, 0.3%/2.5% to EPIDUO® FORTE GEL and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Registry	NCT02709902
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	460 (Actual)
Sponsor	Sun Pharmaceutical Industries, Inc. (Industry)
Conditions	Acne Vulgaris
Interventions	Adapalene/BP gel, 0.3%/2.5%, EPIDUO® FORTE, Placebo (Drug)
Dates	start 2015-09-01, primary completion 2016-02-01, completion 2016-03-01, first posted 2016-03-16, last updated 2017-05-04

-Summary

Bioequivalence with Clinical Endpoints.

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+Detailed description

Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.

+Arms and interventions

Arm	Type	Interventions	Description
Adapalene/BP gel, 0.3%/2.5%	Experimental	Drug: Adapalene/BP gel, 0.3%/2.5%	Topical, once daily, for 84 days.
EPIDUO® FORTE	Active comparator	Drug: EPIDUO® FORTE	Topical, once daily, for 84 days.
Placebo	Placebo comparator	Drug: Placebo	Topical, once daily, for 84 days.

Adapalene/BP gel, 0.3%/2.5% (Drug), also known as Adapalene, benzoyl peroxide: Gel
EPIDUO® FORTE (Drug), also known as Adapalene, benzoyl peroxide: Gel
Placebo (Drug), also known as Vehicle: Gel

+Outcome measures

Primary outcomes

Change in inflammatory lesion counts [Week 12]: Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in non-inflammatory lesion counts [Week 12]: Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

Secondary outcomes

Clinical response of success [Week 12]: The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment

+Eligibility

Sex: All, ages: 12 Years to 40 Years

Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation

+Investigators

Catawba Research, Study chair, http://catawbaresearch.com/contact/