A Phase 1 Study Assessing Local Cutaneous Effects of SB204

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: SB204

• Registration Number: NCT02250430
• Lead Sponsor: Novan, Inc.

Brief Summary

In this study, color (erythema) and pH will be measured on 3 consecutive days after application of 2 doses of SB204 to the cheeks of healthy volunteers.

Detailed Description

This study is to evaluate local cutaneous effects, including intensity and duration of erythema and changes in pH following 5 applications (twice daily for two days and once daily on the third day) of SB204 2% and SB204 4% twice daily to the face for 3 days.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-26
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• Women who are pregnant or nursing
• Subject with known sensitivity to a component of the test materials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical SB204	SB204	Topical application of SB204 2% and 4% twice daily for 2 days and once on Day 3

Primary Outcome Measures

Name	Time	Method
Duration of erythema following application of SB204 2% and SB204 4%.	3 days
Intensity of erythema following application of SB204 2% and SB204 4%.	3 days

Secondary Outcome Measures

Name	Time	Method
pH on the surface of the skin after topical application of 2 concentrations of SB204	3 days

Trial Locations

Locations (1)

KGL; 🇺🇸 Broomall, Pennsylvania, United States