Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801903
• Other study ID #: NI-AC103
• Status: Completed
• Phase: Phase 1
• Start date: June 7, 2016
• Est. completion date: August 25, 2016

Study information

• Verified date: October 2018
• Source: Novan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 25, 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• SB204 4%
Topically Once Daily (AM)

Locations

Country	Name	City	State
United States	WCCT #1	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Novan, Inc.	WCCT Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration	Maximum plasma concentration of plasma hMAP3 on Day 21	Day 21
Primary	AUC - area under the plasma concentration time curve for hMAP3	AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma hMAP3 on Day 21	Day 21
Secondary	Pharmacokinetics as measured by maximum concentration of nitrate	Cmax: maximum plasma concentration of plasma nitrate on Day 21	Day 21
Secondary	Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3	AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma nitrate on Day 21	Day 21
Secondary	Safety profile (Reported adverse events)	Reported adverse events	Day 21/End of Treatment
Secondary	Tolerability (Scores on tolerability assessment)	Scores on tolerability assessment during treatment	Day 21/End of treatment