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NCT02250430 Clinical Trial

A Phase 1 Study Assessing Local Cutaneous Effects of SB204

Acne Vulgaris Clinical Trial

Official title:
A Phase 1, Single-Center, Split-Face Study Assessing Local Cutaneous Effects After Application of SB204 2% and SB204 4% in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02250430
Other study ID # NI-AC102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2014
Est. completion date September 2014

Study information
Verified date November 2018
Source Novan, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• SB204
Applied topically twice a day on days 1, 2 and 3 to left and right cheeks

Locations
Country Name City State
United States KGL Broomall Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Novan, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intensity of erythema following application of SB204 2% and SB204 4%. 3 days
Primary Duration of erythema following application of SB204 2% and SB204 4%. 3 days
Secondary pH on the surface of the skin after topical application of 2 concentrations of SB204 3 days
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