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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

Study Description
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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

Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01241331


Locations
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Sponsors and Collaborators
Braintree Laboratories
More Information
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Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT01241331    
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