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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.
Information provided by:
Dow Pharmaceutical Sciences Identifier:
First received: April 15, 2008
Last updated: April 18, 2008
Last verified: April 2008
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Change from baseline in global severity [ Time Frame: 12 weeks ]

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


Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00663286

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

Responsible Party: Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs, Dow Pharmaceutical Sciences, Inc. 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

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents processed this record on September 19, 2017