Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris

• Status: Completed
• Trial end date: 2016-08-25
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris

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

Details

• Lead Sponsor: Novan, Inc.
• Collaborator: WCCT Global

Criteria

Inclusion Criteria:

• Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale

• At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders

• Age 9-16 years, 11 months inclusive

• Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter

Exclusion Criteria:

• Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis;

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

• Subjects who reside in a dwelling that relies on well water for a primary drinking source

• Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application

• Transgender subjects receiving hormone supplement (male to female or female to male)

• Subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia

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

• Females who are pregnant, planning a pregnancy or breastfeeding

• Subjects previously treated with NVN1000 Gel / SB204