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

Completed · Phase 1

Conditions studied: Acne Vulgaris

In brief

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

Key facts

Study ID

NCT02164084

Run by

Novan, Inc.

People needed

18

Starts

2014-06-01

Expected to finish

2014-12-01

Last updated by the study team

2015-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Spaulding Clinical Research, LLC — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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