BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris | NCT01815450 | Trialant
CompletedInterventionalPhase 2Updated Feb 2, 2015
BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
ClinicalTrials.gov ID
NCT01815450
Lead Sponsor
Braintree LaboratoriesINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
369Actual
Last Update Posted
Feb 2, 2015Estimated
Start Date
Feb 2013
Primary Completion Date
Nov 2013Actual
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.
Acne Vulgaris
BLI1100
BLI1100 - modified formulation
Placebo
Ages Eligible for Study
Child (0-17)Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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