A Phase 1 Study Assessing Local Cutaneous Effects of SB204

Novan, Inc.8 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acne Vulgaris

Interventions

SB204DRUG

Applied topically twice a day on days 1, 2 and 3 to left and right cheeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers Exclusion Criteria: * Women who are pregnant or nursing * Subject with known sensitivity to a component of the test materials

Locations (1)

KGL

Broomall, Pennsylvania, United States

Outcomes

Primary Outcomes

Intensity of erythema following application of SB204 2% and SB204 4%.

Time frame: 3 days

Duration of erythema following application of SB204 2% and SB204 4%.

Time frame: 3 days

Secondary Outcomes

pH on the surface of the skin after topical application of 2 concentrations of SB204

Time frame: 3 days

Data from ClinicalTrials.gov

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