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

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

Bioequivalence with Clinical Endpoints.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Placebo; Drug: Adapalene/BP gel, 0.3%/2.5%; Drug: EPIDUO® FORTE

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 460
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adapalene/BP gel, 0.3%/2.5%; Topical, once daily, for 84 days.	Drug: Adapalene/BP gel, 0.3%/2.5%; Gel; Other Names: Adapalene, benzoyl peroxide
Active Comparator: EPIDUO® FORTE; Topical, once daily, for 84 days.	Drug: EPIDUO® FORTE; Gel; Other Names: Adapalene, benzoyl peroxide
Placebo Comparator: Placebo; Topical, once daily, for 84 days.	Drug: Placebo; Gel; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammatory lesion counts	Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts	Week 12
Change in non-inflammatory lesion counts	Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response of success	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	Week 12

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Benzoyl Peroxide; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination
• Other Study ID Numbers: ADBG 1519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO