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BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

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. Identifier: NCT01241331
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : October 1, 2012
Information provided by (Responsible Party):
Braintree Laboratories

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: BLI1100
BLI1100 topical cream
Drug: BLI1100
BLI110 topical cream

Placebo Comparator: Vehicle cream
Vehicle topical cream
Drug: Vehicle cream
Vehicle topical cream

Primary Outcome Measures :
  1. percent reduction of total acne lesion counts [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. Change in serum chemistry [ Time Frame: 12 weeks ]

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.

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01241331

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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
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

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Responsible Party: Braintree Laboratories 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:
moderate to severe facial acne vulgaris
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases