Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris

NCT02801903 | Completed Phase 1

• 1 other identifier: NI-AC103
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Pharmacokinetics as measured by maximum concentration of nitrate

  Day 21

• Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3

  Day 21

• Safety profile (Reported adverse events)

  Day 21/End of Treatment

• Tolerability (Scores on tolerability assessment)

  Day 21/End of treatment

Study Arms (1)

SB204 4%

EXPERIMENTAL

Topically Once Daily (AM)

Drug: SB204 4%

Interventions

SB204 4% DRUG

Topically Once Daily (AM)

Also known as: NVN1000

SB204 4%

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novan, Inc.: lead
• WCCT Global: collaborator

Study Sites (1)

WCCT #1

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

berdazimer sodium

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• M. Joyce Rico, MD

  Novan, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 16, 2016
• Study Start: June 7, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 25, 2016
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)