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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00666900
First received: April 23, 2008
Last updated: February 16, 2012
Last verified: February 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Improvement from baseline in global severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the number of non-inflammatory lesions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT00666900     History of Changes
Other Study ID Numbers: DPSI-IDP-107-P2-01
Study First Received: April 23, 2008
Last Updated: February 16, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014