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
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
Drug: IDP-110
Drug: Clindamycin
Drug: Benzoyl peroxide
Drug: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Dow Pharmaceutical Sciences:

Primary Outcome Measures:
  • Change from baseline in number of lesions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in global severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 1399
Study Start Date: October 2006
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: IDP-110
Topical application for 12 weeks
Active Comparator: 2 Drug: Clindamycin
Topical application for 12 weeks
Active Comparator: 3 Drug: Benzoyl peroxide
Topical application for 12 weeks
Placebo Comparator: 4 Drug: Vehicle
Topical application for 12 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
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 other than acne that could interfere with clinical evaluations
  • Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663286

  Show 33 Study Locations
Sponsors and Collaborators
Dow Pharmaceutical Sciences
  More Information

No publications provided

Responsible Party: Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs, Dow Pharmaceutical Sciences, Inc.
ClinicalTrials.gov Identifier: NCT00663286     History of Changes
Other Study ID Numbers: DPSI-06-22-2006-017
Study First Received: April 15, 2008
Last Updated: April 18, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014