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OpenTrials
Completed

NCT Number: NCT02709902

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

Bioequivalence with Clinical Endpoints.

Completed

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adapalene/BP gel, 0.3%/2.5%

Drug

Gel

Other names: Adapalene, benzoyl peroxide

EPIDUO® FORTE

Drug

Gel

Other names: Adapalene, benzoyl peroxide

Placebo

Drug

Gel

Other names: Vehicle

Primary outcomes

  1. Change in inflammatory lesion counts

    Time frame: Week 12

    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

  2. Change in non-inflammatory lesion counts

    Time frame: Week 12

    Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

Secondary outcomes

  1. Clinical response of success

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 16, 2016
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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