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BLI1100-202: 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: NCT01815450
Recruitment Status : Completed
First Posted : March 21, 2013
Last Update Posted : February 2, 2015
Information provided by (Responsible Party):
Braintree Laboratories

Brief Summary:
The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to placebo for the treatment of moderate to severe acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: BLI1100 Drug: BLI1100 - modified formulation Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 369 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2013
Actual Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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

Experimental: BLI1100 - modified formulation
BLI1100 topical cream
Drug: BLI1100 - modified formulation
BLI1100 topical cream

Placebo Comparator: Placebo
Topical cream
Drug: Placebo
Placebo topical cream

Primary Outcome Measures :
  1. Change in total lesion count [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Percent change in total lesion count [ Time Frame: Baseline to Week 12 ]
  2. Investigator's Global Assessment [ Time Frame: 12 weeks ]
    Rating of overall facial acne on a 5 point scale (0=clear, 4 = severe)

  3. Local Tolerability Score [ Time Frame: 12 weeks ]
    Rating of facial symptoms on a 4 point scale (0=none, 3=severe)

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:

  • Males or females 12 to 45 years of age with facial acne vulgaris
  • 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): NCT01815450

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United States, California
Center for Dermatology Clincal Research
Fremont, California, United States, 94538
United States, Florida
North Florida Dermatology Associates
Jacksonville, Florida, United States, 32204
Ameriderm Research
Ormond Beach, Florida, United States, 32174
United States, Georgia
Peachtree Dermatology Associates Research Center
Atlanta, Georgia, United States, 30327
United States, Indiana
The Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Michigan
Great Lakes Research Group, Inc.
Bay City, Michigan, United States, 48706
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
Suzanne Bruce and Associates
Houston, Texas, United States, 77056
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
United States, Washington
Women's Clinical Research Center
Seattle, Washington, United States, 98105
Premier Clinical Research
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Braintree Laboratories
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Study Director: John McGowan, MPH Braintree Laboratories, Inc.
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Responsible Party: Braintree Laboratories Identifier: NCT01815450    
Other Study ID Numbers: BLI1100-202
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases