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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
April 23, 2008
April 25, 2008
February 20, 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 ]
  • Improvement from baseline in global severity [ Time Frame: 12 weeks ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00666900
DPSI-IDP-107-P2-01
No
Not Provided
Not Provided
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