Acne Vulgaris
Conditions
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
Interventions
DRUGSB204 4%
Topically Once Daily (AM)
Sponsors
WCCT Global
Novan, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration | Day 21 | Maximum plasma concentration of plasma hMAP3 on Day 21 |
| AUC - area under the plasma concentration time curve for hMAP3 | Day 21 | AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma hMAP3 on Day 21 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics as measured by maximum concentration of nitrate | Day 21 | Cmax: maximum plasma concentration of plasma nitrate on Day 21 |
| Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3 | Day 21 | AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma nitrate on Day 21 |
| Safety profile (Reported adverse events) | Day 21/End of Treatment | Reported adverse events |
| Tolerability (Scores on tolerability assessment) | Day 21/End of treatment | Scores on tolerability assessment during treatment |
Countries
United States
Outcome results
None listed