Clinical trial NCT02801903: Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
Official title: A Phase 1, Single-center, Open-label Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents With Moderate to Severe Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: WCCT Global
First posted: 2016-06-16
Enrollment: 18
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration
timeFrame: Day 21
measure: AUC - area under the plasma concentration time curve for hMAP3
timeFrame: Day 21
Secondary outcomes:
measure: Pharmacokinetics as measured by maximum concentration of nitrate
timeFrame: Day 21
measure: Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3
timeFrame: Day 21
measure: Safety profile (Reported adverse events)
timeFrame: Day 21/End of Treatment
measure: Tolerability (Scores on tolerability assessment)
timeFrame: Day 21/End of treatment
Other outcomes:
Locations:
city: Austin
country: United States
facility: WCCT #1
state: Texas
Study officials:
affiliation: Novan, Inc.
name: M. Joyce Rico, MD
role: STUDY_DIRECTOR
References: