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

Tracking Information
First Submitted Date  ICMJE November 11, 2010
First Posted Date  ICMJE November 16, 2010
Last Update Posted Date October 1, 2012
Study Start Date  ICMJE November 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
percent reduction of total acne lesion counts [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
Official Title  ICMJE A Randomized, Controlled Evaluation of the Safety and Efficacy of a Topical Treatment for Moderate-Severe Facial Acne Vulgaris
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: BLI1100
    BLI110 topical cream
  • Drug: Vehicle cream
    Vehicle topical cream
Study Arms  ICMJE
  • Experimental: BLI1100
    BLI1100 topical cream
    Intervention: Drug: BLI1100
  • Placebo Comparator: Vehicle cream
    Vehicle topical cream
    Intervention: Drug: Vehicle cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2012)
233
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2010)
200
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01241331
Other Study ID Numbers  ICMJE BLI1100-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Braintree Laboratories
Study Sponsor  ICMJE Braintree Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Braintree Laboratories
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP