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Completed

NCT Number: NCT00667173

A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea

The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Affiliated Research Center, Inc., Huntsville, Alabama, 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 facial rosacea
  • Presence of inflammatory lesions

Exclusion criteria

  • Dermatological conditions of the face that could interfere with clinical evaluations
  • Known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption)
  • Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Treatment and study plan

IDP-115

Drug

Topical application for 12 weeks

Vehicle

Drug

Topical application 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 erythema

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Dow Pharmaceutical Sciences

Industry

Registry information

Official study title

A Phase 2, Multi-Center, Evaluator-Blind, Randomized, Vehicle-Controlled Clinical Study to Assess the Safety and Efficacy of IDP-115 in the Treatment of Rosacea

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
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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