A Dose-Ranging 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:
NCT01194375
First received: September 1, 2010
Last updated: June 20, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Low Strength IDP-107 Drug: High Strength IDP-107 Drug: Placebo |
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 |
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: Baseline and 22 weeks ] [ Designated as safety issue: No ]
- Percent of patients who achieve success for the acne global severity score [ Time Frame: Baseline and 22 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in the number of non-inflammatory lesions [ Time Frame: Baseline and 22 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 180 |
| Study Start Date: | September 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Low Strength IDP-107 |
Drug: Low Strength IDP-107
Once a day for 16 weeks
|
| Experimental: High Strength IDP-107 |
Drug: High Strength IDP-107
Once a day for 16 weeks
|
| Placebo Comparator: Placebo |
Drug: Placebo
Once a day for 16 weeks
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Presence of acne vulgaris on the face and neck/trunk
- Presence of inflammatory and non-inflammatory lesions on the face
Exclusion Criteria:
- Presence of any skin condition on the face that could interfere with clinical evaluations
- Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
- Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194375
Locations
| United States, California | |
| Dermatology Specialists, Inc. | |
| Oceanside, California, United States, 92056 | |
| United States, Colorado | |
| Horizons Clinical Research Center, LLC | |
| Denver, Colorado, United States, 80220 | |
| United States, Florida | |
| North Florida Dermatology Associates, PA | |
| Jacksonville, Florida, United States, 32204 | |
| FXM Research Corp. | |
| Miami, Florida, United States, 33175 | |
| Ameriderm Research | |
| Ormond Beach, Florida, United States, 32174 | |
| United States, Indiana | |
| Dawes Fretzin Clinical Research Group, LLC | |
| Indianapolis, Indiana, United States, 46256 | |
| The Indiana Clinical Trials Center, PC | |
| Plainfield, Indiana, United States, 46168 | |
| United States, Kentucky | |
| Pedia Research LLC | |
| Owensboro, Kentucky, United States, 42301 | |
| United States, Massachusetts | |
| ActivMed Practices and Research, Inc. | |
| Haverhill, Massachusetts, United States, 01830 | |
| United States, Michigan | |
| Hamzavi Dermatology | |
| Fort Gratiot, Michigan, United States, 48059 | |
| United States, Minnesota | |
| Minnesota Clinical Study Center | |
| Fridley, Minnesota, United States, 55432 | |
| United States, New Jersey | |
| Comprehensive Clinical Research | |
| Berlin, New Jersey, United States, 08009 | |
| United States, Oregon | |
| Oregon Dermatology and Research Center | |
| Portland, Oregon, United States, 97210 | |
| United States, Texas | |
| DermResearch, Inc. | |
| Austin, Texas, United States, 78759 | |
| United States, Utah | |
| Dermatology Research Center, Inc. | |
| Salt Lake City, Utah, United States, 84124 | |
| South Valley Dermatology | |
| West Jordan, Utah, United States, 84088 | |
| United States, Washington | |
| Premier Clinical Research | |
| Spokane, Washington, United States, 99204 | |
| Canada, Ontario | |
| Ultranova Skincare | |
| Barrie, Ontario, Canada, L4M 6L2 | |
| The Centre for Dermatology and Cosmetic Surgery | |
| Richmond Hill, Ontario, Canada, L4B 1A5 | |
| K. Papp Clinical Research | |
| Waterloo, Ontario, Canada, N2J 1C4 | |
Sponsors and Collaborators
Dow Pharmaceutical Sciences
More Information
No publications provided
| Responsible Party: | Dow Pharmaceutical Sciences |
| ClinicalTrials.gov Identifier: | NCT01194375 History of Changes |
| Other Study ID Numbers: | DPSI-IDP-107-P2-02 |
| Study First Received: | September 1, 2010 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |
ClinicalTrials.gov processed this record on May 16, 2013