Trial record 66 of 233 for:
acne AND Percent
BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
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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. |
| ClinicalTrials.gov Identifier: NCT01241331 |
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Recruitment Status :
Completed
First Posted : November 16, 2010
Last Update Posted : October 1, 2012
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Sponsor:
Braintree Laboratories
Information provided by (Responsible Party):
Braintree Laboratories
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Brief Summary:
The purpose of this study is to compare the safety and efficacy of formulation BLI1100 to its vehicle in the treatment of moderate-severe acne vulgaris.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acne Vulgaris | Drug: BLI1100 Drug: Vehicle cream | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 233 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Controlled Evaluation of the Safety and Efficacy of a Topical Treatment for Moderate-Severe Facial Acne Vulgaris |
| Study Start Date : | November 2010 |
| Actual Primary Completion Date : | April 2011 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: BLI1100
BLI1100 topical cream
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Drug: BLI1100
BLI110 topical cream |
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Placebo Comparator: Vehicle cream
Vehicle topical cream
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Drug: Vehicle cream
Vehicle topical cream |
Primary Outcome Measures :
- percent reduction of total acne lesion counts [ Time Frame: 12 weeks ]
Secondary Outcome Measures :
- Investigator's Global Assessment [ Time Frame: 12 ]Rating of overall facial acne on a 4 point scale (0=clear to 4=severe) performed by a blinded investigator.
- Change in serum chemistry [ Time Frame: 12 weeks ]
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| Ages Eligible for Study: | 12 Years to 45 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Qualifying Investigator's Global Assessment severity score
- Qualifying number of non-inflammatory lesions
- Qualifying number of inflammatory lesions
Exclusion Criteria:
- Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
- Using medications that are reported to exacerbate acne
- Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin
- Have a known hypersensitivity or previous allergic reaction to any of the components
- Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
- Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
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): NCT01241331
Locations
| United States, California | |
| Center for Dermatology Clincal Research | |
| Fremont, California, United States, 94538 | |
| Dermatology Research Associates | |
| Los Angeles, California, United States, 90045 | |
| Dermatology Specialists | |
| Oceanside, California, United States, 92056 | |
| United States, Colorado | |
| Horizons Clinical Research Center | |
| Denver, Colorado, United States, 80220 | |
| United States, Florida | |
| North Florida Dermatology Associates | |
| Jacksonville, Florida, United States, 32204 | |
| Ameriderm Research | |
| Ormond Beach, Florida, United States, 32174 | |
| United States, Georgia | |
| Atlanta Dermatology, Vein and Research Center | |
| Alpharetta, Georgia, United States, 30022 | |
| Peachtree Dermatology Associates Research Center | |
| Atlanta, Georgia, United States, 30327 | |
| United States, Idaho | |
| Northwest Clinical Trials | |
| Nampa, Idaho, United States, 83686 | |
| United States, Indiana | |
| The Indiana Clinical Trials Center | |
| Plainfield, Indiana, United States, 46168 | |
| The South Bend Clinic | |
| South Bend, Indiana, United States, 46617 | |
| United States, Minnesota | |
| Minnesota Clinical Study Center | |
| Fridley, Minnesota, United States, 55432 | |
| United States, New Mexico | |
| Academic Dermatology Associates | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, Rhode Island | |
| Clinical Partners | |
| Johnston, Rhode Island, United States, 02919 | |
| United States, Texas | |
| DiscoveResearch | |
| Bryan, Texas, United States, 77802 | |
| Progressive Clinical Research | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Dermatology Research Center | |
| Salt Lake City, Utah, United States, 84124 | |
| United States, Virginia | |
| The Education and Research Foundation | |
| Lynchburg, Virginia, United States, 24501 | |
| Virginia Clinical Research | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Premier Clinical Research | |
| Spokane, Washington, United States, 99204 | |
Sponsors and Collaborators
Braintree Laboratories
| Responsible Party: | Braintree Laboratories |
| ClinicalTrials.gov Identifier: | NCT01241331 History of Changes |
| Other Study ID Numbers: |
BLI1100-201 |
| First Posted: | November 16, 2010 Key Record Dates |
| Last Update Posted: | October 1, 2012 |
| Last Verified: | September 2012 |
Keywords provided by Braintree Laboratories:
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moderate to severe facial acne vulgaris |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases |