BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

Braintree Laboratories

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Placebo; Drug: BLI1100 - modified formulation; Drug: BLI1100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01815450

BLI1100-202

Details and patient eligibility

About

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.

Enrollment: 369 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

369 participants in 3 patient groups, including a placebo group

BLI1100

Experimental group

Description:

BLI1100 topical cream

Treatment:

Drug: BLI1100

BLI1100 - modified formulation

Experimental group

Description:

BLI1100 topical cream

Treatment:

Drug: BLI1100 - modified formulation

Placebo

Placebo Comparator group

Description:

Topical cream

Treatment:

Drug: Placebo