A 2 Period Cross-over Pharmacokinetic Study of SB204 in Acne Vulgaris

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will identify how much (if any) drug is absorbed from the skin of subjects with acne vulgaris after topical application of SB204.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novan, Inc.

Criteria

Inclusion Criteria:

• Male and female subjects with an acne severity of moderate or severe and a minimum of 20 inflammatory and 20 non-inflammatory lesions on the face, trunk and shoulders

• 18 years of age and older

Exclusion Criteria:

• Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.

• Subjects who smoke or use tobacco products

• Subjects with methemoglobin level greater than 2% at Screening or Baseline by pulse co-oximeter.

• Subjects with a previous history of methemoglobinemia

• Subjects being treated with nitrates or any drug associated with methemoglobinemia

• Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens.