Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01815450
Recruitment Status : Completed
First Posted : March 21, 2013
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Tracking Information
First Submitted Date  ICMJE March 18, 2013
First Posted Date  ICMJE March 21, 2013
Last Update Posted Date February 2, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
Change in total lesion count [ Time Frame: Baseline to Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01815450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
  • Percent change in total lesion count [ Time Frame: Baseline to Week 12 ]
  • Investigator's Global Assessment [ Time Frame: 12 weeks ]
    Rating of overall facial acne on a 5 point scale (0=clear, 4 = severe)
  • Local Tolerability Score [ Time Frame: 12 weeks ]
    Rating of facial symptoms on a 4 point scale (0=none, 3=severe)
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 BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: BLI1100
    BLI1100 topical cream
  • Drug: BLI1100 - modified formulation
    BLI1100 topical cream
  • Drug: Placebo
    Placebo topical cream
Study Arms  ICMJE
  • Experimental: BLI1100
    BLI1100 topical cream
    Intervention: Drug: BLI1100
  • Experimental: BLI1100 - modified formulation
    BLI1100 topical cream
    Intervention: Drug: BLI1100 - modified formulation
  • Placebo Comparator: Placebo
    Topical cream
    Intervention: Drug: Placebo
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: January 26, 2015)
369
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2013)
300
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT01815450
Other Study ID Numbers  ICMJE BLI1100-202
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
Study Director: John McGowan, MPH Braintree Laboratories, Inc.
PRS Account Braintree Laboratories
Verification Date January 2015

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