Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Dose-Ranging 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:
NCT01194375
First received: September 1, 2010
Last updated: June 20, 2012
Last verified: June 2012

September 1, 2010
June 20, 2012
September 2010
December 2011   (final data collection date for primary outcome measure)
  • Change from baseline in the number of inflammatory lesions [ Time Frame: Baseline and 22 weeks ] [ Designated as safety issue: No ]
  • Percent of patients who achieve success for the acne global severity score [ Time Frame: Baseline and 22 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01194375 on ClinicalTrials.gov Archive Site
Change from baseline in the number of non-inflammatory lesions [ Time Frame: Baseline and 22 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
Not Provided

The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo 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 16 weeks
  • Drug: High Strength IDP-107
    Once a day for 16 weeks
  • Drug: Placebo
    Once a day for 16 weeks
  • Experimental: Low Strength IDP-107
    Intervention: Drug: Low Strength IDP-107
  • Experimental: High Strength IDP-107
    Intervention: Drug: High Strength IDP-107
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presence of acne vulgaris on the face and neck/trunk
  • Presence of inflammatory and non-inflammatory lesions on the face

Exclusion Criteria:

  • Presence of any skin condition on the face that could interfere with clinical evaluations
  • Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
  • Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
  • Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01194375
DPSI-IDP-107-P2-02
Not Provided
Dow Pharmaceutical Sciences
Dow Pharmaceutical Sciences
Not Provided
Not Provided
Dow Pharmaceutical Sciences
June 2012

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