A Dose-Ranging 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

• Registration Number: NCT01194375
• Lead Sponsor: Dow Pharmaceutical Sciences

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-03
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-06
• Disposition First Submitted: 2012-06-20
• Disposition First Submitted QC: 2012-06-20
• Last Update Submitted: 2012-06-20
• Disposition First Posted: 2012-07-02
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Presence of acne vulgaris on the face and neck/trunk
• Presence of inflammatory and non-inflammatory lesions on the face

Exclusion Criteria

• Presence of any skin condition on the face that could interfere with clinical evaluations
• Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
• Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Strength IDP-107	Low Strength IDP-107	-
High Strength IDP-107	High Strength IDP-107	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the number of inflammatory lesions	Baseline and 22 weeks
Percent of patients who achieve success for the acne global severity score	Baseline and 22 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the number of non-inflammatory lesions	Baseline and 22 weeks

Trial Locations

Locations (20)

Dermatology Specialists, Inc.; 🇺🇸 Oceanside, California, United States

Horizons Clinical Research Center, LLC; 🇺🇸 Denver, Colorado, United States

North Florida Dermatology Associates, PA; 🇺🇸 Jacksonville, Florida, United States

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

Ameriderm Research; 🇺🇸 Ormond Beach, Florida, United States

Dawes Fretzin Clinical Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

The Indiana Clinical Trials Center, PC; 🇺🇸 Plainfield, Indiana, United States

Pedia Research LLC; 🇺🇸 Owensboro, Kentucky, United States

ActivMed Practices and Research, Inc.; 🇺🇸 Haverhill, Massachusetts, United States

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

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