BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

Braintree Laboratories

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: BLI1100; Drug: Vehicle cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01241331

BLI1100-201

Details and patient eligibility

About

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.

Enrollment: 233 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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233 participants in 2 patient groups, including a placebo group

BLI1100

Experimental group

Description:

BLI1100 topical cream

Treatment:

Drug: BLI1100

Vehicle cream

Placebo Comparator group

Description:

Vehicle topical cream

Treatment:

Drug: Vehicle cream