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Completed

NCT Number: NCT04321070

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

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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

Primary location

Catawba Research LLC

Charlotte, North Carolina, 28217, United States

About this study

Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

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.
  • Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent.
  • Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion criteria

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
  • Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.

Treatment and study plan

Clindamycin Phosphate

Drug

A thin film of investigation product will be applied to the affected areas of the face once daily

Other names: Lotion

Clindamycin Phosphate RLD

Drug

A thin film of investigation product will be applied to the affected areas of the face once daily

Other names: Lotion

Placebos

Drug

A thin film of investigation product will be applied to the affected areas of the face once daily

Other names: Vehicle

Primary outcomes

  1. Demonstration of Bioequivalence

    Time frame: Week 12

    Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 25, 2020
Registry last updated
Apr 10, 2025

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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