NCT02801903

Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Novan, Inc. · Industry
• Sex: All
• Age: 9 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	SB204 4%	Topically Once Daily (AM)

Timeline

• Start date: 2016-06-07
• Primary completion: 2016-08-01
• Completion: 2016-08-25
• First posted: 2016-06-16
• Last updated: 2018-10-12

Locations

1 site across 1 country: United States