BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT01241331
First received: November 11, 2010
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Acne Vulgaris
Drug: BLI1100
Drug: Vehicle cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • percent reduction of total acne lesion counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator's Global Assessment [ Time Frame: 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Enrollment: 233
Study Start Date: November 2010
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BLI1100
BLI1100 topical cream
Drug: BLI1100
BLI110 topical cream
Placebo Comparator: Vehicle cream
Vehicle topical cream
Drug: Vehicle cream
Vehicle topical cream

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT01241331     History of Changes
Other Study ID Numbers: BLI1100-201
Study First Received: November 11, 2010
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
moderate to severe facial acne vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on April 22, 2014