Acne Vulgaris
Conditions
Keywords
moderate to severe facial acne vulgaris
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.
Interventions
DRUGBLI1100
BLI110 topical cream
DRUGVehicle cream
Vehicle topical cream
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percent reduction of total acne lesion counts | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment | 12 | Rating of overall facial acne on a 4 point scale (0=clear to 4=severe) performed by a blinded investigator. |
| Change in serum chemistry | 12 weeks | — |
Countries
United States
Outcome results
None listed