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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Low Strength IDP-107; Drug: High Strength IDP-107; Drug: Placebo Comparator

• Registration Number: NCT00666900
• Lead Sponsor: Dow Pharmaceutical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-25
• Primary Completion: 2009-03
• Study Completion: 2009-09
• Disposition First Submitted: 2010-09-15
• Disposition First Submitted QC: 2010-09-15
• Disposition First Posted: 2010-09-17
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-16
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Low Strength IDP-107	-
2	High Strength IDP-107	-
3	Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the number of inflammatory lesions	12 weeks
Improvement from baseline in global severity	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the number of non-inflammatory lesions	12 weeks

Trial Locations

Locations (25)

Burke Pharmaceutical Research; 🇺🇸 Hot Springs, Arkansas, United States

Dermatology Research of Arkansas, PLLC; 🇺🇸 Little Rock, Arkansas, United States

RADY Children's Hospital - San Diego; 🇺🇸 San Diego, California, United States

Clinical Science Institute; 🇺🇸 Santa Monica, California, United States

Solano Clinical Research; 🇺🇸 Vallejo, California, United States

Cherry Creek Research, Inc.; 🇺🇸 Denver, Colorado, United States

FXM Research Corp.; 🇺🇸 Miami, Florida, United States

Michigan Center for Skin Care Research; 🇺🇸 Clinton Township, Michigan, United States

Hamzavi Dermatology; 🇺🇸 Fort Gratiot, Michigan, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

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