Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris

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

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: SB204 4%

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78759
      • WCCT #1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SB204 4%; Topically Once Daily (AM)	Drug: SB204 4%; Topically Once Daily (AM); Other Names: NVN1000

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration	Maximum plasma concentration of plasma hMAP3 on Day 21	Day 21
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics as measured by maximum concentration of nitrate	Cmax: maximum plasma concentration of plasma nitrate on Day 21	Day 21
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
Safety profile (Reported adverse events)	Reported adverse events	Day 21/End of Treatment
Tolerability (Scores on tolerability assessment)	Scores on tolerability assessment during treatment	Day 21/End of treatment

Collaborators and Investigators

• Sponsor: Novan, Inc.
• Collaborators: WCCT Global
• Investigators: Study Director: M. Joyce Rico, MD, Novan, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 25, 2016

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: NI-AC103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO