Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris

NCT ID: NCT02801903

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-07
• Study Completion Date: 2016-08-25

Brief Summary

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

Detailed Description

This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day 21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SB204 4%

Topically Once Daily (AM)

Group Type: EXPERIMENTAL

SB204 4%

Intervention Type: DRUG

Topically Once Daily (AM)

Interventions

SB204 4%

Topically Once Daily (AM)

Intervention Type: DRUG

Other Intervention Names

NVN1000

Eligibility 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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

WCCT Global

INDUSTRY

Sponsor Role: collaborator

Novan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Joyce Rico, MD

Role: STUDY_DIRECTOR

Novan, Inc.

Locations

WCCT #1

Austin, Texas, United States

Countries

United States

Other Identifiers

NI-AC103

Identifier Type: -

Identifier Source: org_study_id