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Completed

NCT Number: NCT00666900

A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Burke Pharmaceutical Research, Hot Springs, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of inflammatory and non-inflammatory lesions

Exclusion criteria

  • Dermatological conditions of the face that could interfere with clinical evaluations
  • Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Treatment and study plan

Low Strength IDP-107

Drug

Once a day for 12 weeks

High Strength IDP-107

Drug

Once a day for 12 weeks

placebo comparator

Drug

Once a day for 12 weeks

Primary outcomes

  1. Change from baseline in the number of inflammatory lesions

    Time frame: 12 weeks

  2. Improvement from baseline in global severity

    Time frame: 12 weeks

Secondary outcomes

  1. Change from baseline in the number of non-inflammatory lesions

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Dow Pharmaceutical Sciences

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Double-Blind, Dose-Ranging Study to Evaluate IDP-107 Versus Placebo in the Treatment of Severe Acne Vulgaris With Nodules

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 25, 2008
Registry last updated
Feb 20, 2012

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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