Skip to main content
OpenTrials
Completed

NCT Number: NCT01138514

Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels

The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy men or women, 12 to 65 years of age
  • Willing to participate and sign provide written consent
  • Moderate to severe acne

Exclusion criteria

  • Pregnant or lactating women
  • History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin
  • Use of systemic, topical or facial products which may interfere with the study
  • Participation in any clinical study in the 30 days prior to study entry
  • Prolonged exposure to sunlight or excessive exposure to UV lights
  • Chronic use of NSAIDS

Treatment and study plan

Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)

Drug

Applied to the entire face twice daily for 10 weeks

Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)

Drug

Applied to the entire face twice daily for 10 weeks

Placebo

Drug

Placebo

Primary outcomes

  1. Percent Change From Baseline in Inflammatory Lesions

    Time frame: 10 weeks

  2. Percent Change From Baseline in Non-inflammatory Lesions

    Time frame: 10 weeks

Secondary outcomes

  1. Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)

    Time frame: 10 weeks

    Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.

Sponsors and collaborators

Lead sponsor

Padagis LLC

Industry

Registry information

Official study title

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 7, 2010
Registry last updated
Oct 13, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.