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Clinical Trial Summary

A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris


Clinical Trial Description

This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day 21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02801903
Study type Interventional
Source Novan, Inc.
Contact
Status Completed
Phase Phase 1
Start date June 7, 2016
Completion date August 25, 2016

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