Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel

Status Completed

Clinical Trial Summary

This is a multi center open label study intended to provide photo documentation and time to response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to severe non-nodular inflammatory acne vulgarism.

Clinical Trial Description

This was a 12-week, multi-center, open label, two-arm study. Subjects will be assigned to treatment with 1% or 2% BPX-01 gel. 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. Photographs will be taken to document treatment effect. 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, incidence of product related facial staining and collection of adverse events. ;

Study Design

Related Conditions & MeSH terms

Acne Vulgaris

Clinical Trial Details

NCT number	NCT02946788
Study type	Interventional
Source	BioPharmX, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	March 13, 2017
Completion date	June 1, 2018

View Details

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