A Phase 1 Study Assessing Local Cutaneous Effects of SB204

Novan

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: SB204

Study type: Interventional

Funder types: Industry

Identifiers

NCT02250430

NI-AC102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Topical SB204

Experimental group

Description:

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

Treatment:

Drug: SB204