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

This study has been completed.
Sponsor:
Information provided by:
Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00663286
First received: April 15, 2008
Last updated: April 18, 2008
Last verified: April 2008

April 15, 2008
April 18, 2008
October 2006
August 2007   (final data collection date for primary outcome measure)
Change from baseline in number of lesions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00663286 on ClinicalTrials.gov Archive Site
Change from baseline in global severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Clinical Trial Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris
Not Provided

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: IDP-110
    Topical application for 12 weeks
  • Drug: Clindamycin
    Topical application for 12 weeks
  • Drug: Benzoyl peroxide
    Topical application for 12 weeks
  • Drug: Vehicle
    Topical application for 12 weeks
  • Experimental: 1
    Intervention: Drug: IDP-110
  • Active Comparator: 2
    Intervention: Drug: Clindamycin
  • Active Comparator: 3
    Intervention: Drug: Benzoyl peroxide
  • Placebo Comparator: 4
    Intervention: Drug: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1399
Not Provided
August 2007   (final data collection date for primary outcome measure)

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
Both
12 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00663286
DPSI-06-22-2006-017
Not Provided
Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs, Dow Pharmaceutical Sciences, Inc.
Dow Pharmaceutical Sciences
Not Provided
Not Provided
Dow Pharmaceutical Sciences
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP