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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
History of Changes
  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:

MedlinePlus related topics: Acne
U.S. FDA Resources

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
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
Clindamycin
Clindamycin-2-phosphate
 Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 16, 2013