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

April 23, 2008
February 16, 2012
January 2008
March 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00666900 on ClinicalTrials.gov Archive Site
Change from baseline in the number of non-inflammatory lesions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
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

The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with acne vulgaris.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: Low Strength IDP-107
    Once a day for 12 weeks
  • Drug: High Strength IDP-107
    Once a day for 12 weeks
  • Drug: Placebo Comparator
    Once a day for 12 weeks
  • Experimental: 1
    Intervention: Drug: Low Strength IDP-107
  • Experimental: 2
    Intervention: Drug: High Strength IDP-107
  • Placebo Comparator: 3
    Intervention: Drug: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
366
September 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00666900
DPSI-IDP-107-P2-01
No
Dow Pharmaceutical Sciences
Dow Pharmaceutical Sciences
Not Provided
Not Provided
Dow Pharmaceutical Sciences
February 2012

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