Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
Study Details
Study Description
Brief Summary
A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SB204 4% Topically Once Daily (AM) |
Drug: SB204 4%
Topically Once Daily (AM)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | WCCT #1 | Austin | Texas | United States | 78759 |
Sponsors and Collaborators
- Novan, Inc.
- WCCT Global
Investigators
- Study Director: M. Joyce Rico, MD, Novan, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NI-AC103