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A Clinical Study Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00664248
First Posted: April 22, 2008
Last Update Posted: April 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dow Pharmaceutical Sciences
  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
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: 1414
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664248


  Show 35 Study Locations
Sponsors and Collaborators
Dow Pharmaceutical Sciences
  More Information

Responsible Party: Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs, Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT00664248     History of Changes
Other Study ID Numbers: DPSI-06-22-2006-012
First Submitted: April 15, 2008
First Posted: April 22, 2008
Last Update Posted: April 22, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Clindamycin
Benzoyl Peroxide
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents