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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666900

  Show 25 Study Locations
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
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on April 15, 2014