A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
This study has been completed.
Sponsor:
Dow Pharmaceutical Sciences
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
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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
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Hide Study LocationsLocations
| United States, Arkansas | |
| Burke Pharmaceutical Research | |
| Hot Springs, Arkansas, United States, 71913 | |
| Dermatology Research of Arkansas, PLLC | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| RADY Children's Hospital - San Diego | |
| San Diego, California, United States, 92123 | |
| Clinical Science Institute | |
| Santa Monica, California, United States, 90404 | |
| Solano Clinical Research | |
| Vallejo, California, United States, 94589 | |
| United States, Colorado | |
| Cherry Creek Research, Inc. | |
| Denver, Colorado, United States, 80209 | |
| United States, Florida | |
| FXM Research Corp. | |
| Miami, Florida, United States, 33175 | |
| United States, Michigan | |
| Michigan Center for Skin Care Research | |
| Clinton Township, Michigan, United States, 48038 | |
| Hamzavi Dermatology | |
| Fort Gratiot, Michigan, United States, 48059 | |
| United States, Minnesota | |
| Minnesota Clinical Study Center | |
| Fridley, Minnesota, United States, 55432 | |
| United States, Nebraska | |
| Skin Specialist, PC | |
| Omaha, Nebraska, United States, 68144 | |
| United States, New Mexico | |
| Academic Dermatology Associates | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Dermatology Associates of Rochester | |
| Rochester, New York, United States, 14623 | |
| DermResearchCenter of New York, Inc. | |
| Stony Brook, New York, United States, 11790 | |
| United States, North Carolina | |
| University of North Carolina Hospitals and School of Medicine | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Oregon Dermatology and Research Center | |
| Portland, Oregon, United States, 97210 | |
| United States, Texas | |
| Arlington Research Center, Inc. | |
| Arlington, Texas, United States, 76011 | |
| DermResearch, Inc. | |
| Austin, Texas, United States, 78759 | |
| J & S Studies, Inc. | |
| Bryan, Texas, United States, 77802 | |
| The Center for Skin Research | |
| Houston, Texas, United States, 77056 | |
| United States, Utah | |
| South Valley Dermatology | |
| West Jordan, Utah, United States, 84088 | |
| United States, Virginia | |
| Virginia Clinical Research, Inc. | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Premier Clinical Research | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Madison Skin & Research, Inc. | |
| Madison, Wisconsin, United States, 53719 | |
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 June 17, 2013