BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris
Status:
Completed
Trial end date:
2017-03-24
Target enrollment:
Participant gender:
Summary
This is a 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled
study.
Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. Subjects will apply
1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night
for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be
performed to assess efficacy.
Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the
level of minocycline in plasma. Safety will be assessed with the vital signs, brief physical
examination, clinical laboratory tests, cutaneous tolerance score, incidence of
minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches
suggestive of pseudotumor cerebri, and collection of adverse events.