A Clinical Trial Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris

The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Vehicle; Drug: IDP-110; Drug: Clindamycin; Drug: Benzoyl peroxide

• Study Type: Interventional
• Enrollment (Actual): 1399
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • The Savin Center, PC
  • Delaware
    • Hockessin, Delaware, United States, 19707
      • Webster Dermatology, PA
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Inc.
    • Clermont, Florida, United States, 34711
      • Advanced Dermatology and Cosmetic Surgery
    • Jacksonville, Florida, United States, 32204
      • North Florida Dermatology Associates, PA
    • Ormond Beach, Florida, United States, 32174
      • Advanced Dermatology and Cosmetic Surgery
    • Pinellas Park, Florida, United States, 33781
      • Dermatology Research
    • West Palm Beach, Florida, United States, 33401
      • Florida Dermatology Institute
  • Georgia
    • Augusta, Georgia, United States, 30904
      • Derm Center of Augusta
    • Newnan, Georgia, United States, 30263
      • MedaPhase Inc.
    • Snellville, Georgia, United States, 30078
      • Gwinnett Clinical Research Center, Inc.
  • Illinois
    • Naperville, Illinois, United States, 60563
      • DuPage Medical Group
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Hudson Dermatology
    • South Bend, Indiana, United States, 46617
      • South Bend Clinic
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists Research
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Research Corp.
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
    • Brooklyn, New York, United States, 11234
      • Atlantic Dermatologic Associates, LLP
    • New York, New York, United States, 10021
      • Office of Fran E. Cook-Bolden, MD
    • Rochester, New York, United States, 14623
      • Dermatology Associates of Rochester
    • Rochester, New York, United States, 14609
      • Helendale Dermatology and Medical Spa
    • Stony Brook, New York, United States, 11790
      • DermResearch Center of New York
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Central Sooner Research
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Milton S. Hershey Medical Center
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • Bryan, Texas, United States, 77802
      • J & S Studies, Inc.
    • Carrollton, Texas, United States, 75006
      • Thomas J. Stephens & Associates
    • Dallas, Texas, United States, 75246
      • Dallas Associated Dermatologists
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Education & Research Foundation
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Madison Skin & Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: IDP-110; Topical application for 12 weeks
Active Comparator: 2	Drug: Clindamycin; Topical application for 12 weeks
Placebo Comparator: 4	Drug: Vehicle; Topical application for 12 weeks
Active Comparator: 3	Drug: Benzoyl peroxide; Topical application for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in number of lesions	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in global severity	12 weeks

Collaborators and Investigators

• Sponsor: Dow Pharmaceutical Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: April 15, 2008
• First Submitted That Met QC Criteria: April 18, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Estimate): April 22, 2008
• Last Update Submitted That Met QC Criteria: April 18, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
• Other Study ID Numbers: DPSI-06-22-2006-017