A Phase 1, Single-center, Double-blind, Randomized, Cross-over, Pharmacokinetics, Safety and Tolerability Study of SB204 8% (NVN1000 Gel) and Vehicle Gel
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novan, Inc.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics of nitrate and silicon
Study Overview
Brief Summary
This study will identify how much (if any) drug is absorbed from the skin of subjects with acne vulgaris after topical application of SB204.
Detailed Description
This is a single-center, double-blind, randomized, 2 period cross-over study to be conducted in 18 subjects (18 years of age and above) each of whom will receive SB204 8% and Vehicle Gel. Subjects who satisfy the entry criteria will be randomized to SB204 8% or Vehicle Gel in a 1:1 ratio for the first treatment period. Study drug will be applied to the face, upper chest, upper back and shoulders (approximately 17% BSA) twice daily on Days 1- 4 approximately 12 hours apart. On Day 5, the study drug will be applied to the same areas only once, in the morning. Pharmacokinetic (PK) profiling will be performed on Day 1 and Day 5. After a wash out period, subjects will be treated with the alternate product and undergo similar treatment and assessments. The primary assessment is the pharmacokinetic profile of nitrate and silicon as markers for systemic exposure to nitric oxide (nitrate) and NVN1000 (silicon) after topical application of SB204 8% to approximately 17% of the total body surface area.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female subjects with an acne severity of moderate or severe and a minimum of 20 inflammatory and 20 non-inflammatory lesions on the face, trunk and shoulders
- •18 years of age and older
Exclusion Criteria
- •Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
- •Subjects who smoke or use tobacco products
- •Subjects with methemoglobin level greater than 2% at Screening or Baseline by pulse co-oximeter.
- •Subjects with a previous history of methemoglobinemia
- •Subjects being treated with nitrates or any drug associated with methemoglobinemia
- •Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens.
Arms & Interventions
SB204
SB204 8% topically twice daily for 4 days and once on Day 5
Intervention: SB204 (Drug)
Vehicle Gel
Vehicle Gel topically twice daily for 4 days and once on Day 5
Intervention: Vehicle Gel (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics of nitrate and silicon
Time Frame: After single dose and multiple dose (Day 5) application
Standard PK parameters including area under the curve (AUC) 0-∞, AUC0-t, Cmax, Cmin, and T1/2, for nitrate and silicon. Calculations may be based on actual and/or baseline-subtracted concentrations for nitrate.
Secondary Outcomes
- Safety(Safety will be assessed throughout the study duration (up to 7 weeks).)