Condition: Acne Vulgaris · Sponsor: BioPharmX, Inc.
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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Study site | Santa Monica, California, United States | — |
| Study site | Coral Gables, Florida, United States | — |
| Study site | Lake Mary, Florida, United States | — |
| Study site | Newnan, Georgia, United States | — |
| Study site | Louisville, Kentucky, United States | — |
| Study site | Las Vegas, Nevada, United States | — |
| Study site | Montclair, New Jersey, United States | — |
| Study site | New York, New York, United States | — |
| Study site | Highpoint, North Carolina, United States | — |
| Study site | Murfreesboro, Tennessee, United States | — |
| Study site | Nashville, Tennessee, United States | — |
| Study site | Pflugerville, Texas, United States | — |
+ 3 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT02815332