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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00666900
First Posted: April 25, 2008
Last Update Posted: February 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dow Pharmaceutical Sciences
  Purpose
The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with acne vulgaris.

Condition Intervention Phase
Acne Vulgaris Drug: Low Strength IDP-107 Drug: High Strength IDP-107 Drug: Placebo Comparator Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Dow Pharmaceutical Sciences:

Primary Outcome Measures:
  • Change from baseline in the number of inflammatory lesions [ Time Frame: 12 weeks ]
  • Improvement from baseline in global severity [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Change from baseline in the number of non-inflammatory lesions [ Time Frame: 12 weeks ]

Enrollment: 366
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Low Strength IDP-107
Once a day for 12 weeks
Experimental: 2 Drug: High Strength IDP-107
Once a day for 12 weeks
Placebo Comparator: 3 Drug: Placebo Comparator
Once a day for 12 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666900


  Hide Study Locations
Locations
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
Dermatology Research of Arkansas, PLLC
Little Rock, Arkansas, United States, 72205
United States, California
RADY Children's Hospital - San Diego
San Diego, California, United States, 92123
Clinical Science Institute
Santa Monica, California, United States, 90404
Solano Clinical Research
Vallejo, California, United States, 94589
United States, Colorado
Cherry Creek Research, Inc.
Denver, Colorado, United States, 80209
United States, Florida
FXM Research Corp.
Miami, Florida, United States, 33175
United States, Michigan
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States, 48038
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Nebraska
Skin Specialist, PC
Omaha, Nebraska, United States, 68144
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
DermResearchCenter of New York, Inc.
Stony Brook, New York, United States, 11790
United States, North Carolina
University of North Carolina Hospitals and School of Medicine
Chapel Hill, North Carolina, United States, 27599
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, Texas
Arlington Research Center, Inc.
Arlington, Texas, United States, 76011
DermResearch, Inc.
Austin, Texas, United States, 78759
J & S Studies, Inc.
Bryan, Texas, United States, 77802
The Center for Skin Research
Houston, Texas, United States, 77056
United States, Utah
South Valley Dermatology
West Jordan, Utah, United States, 84088
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99204
United States, Wisconsin
Madison Skin & Research, Inc.
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
Dow Pharmaceutical Sciences
  More Information

Responsible Party: Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT00666900     History of Changes
Other Study ID Numbers: DPSI-IDP-107-P2-01
First Submitted: April 23, 2008
First Posted: April 25, 2008
Last Update Posted: February 20, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases