A 2 Period Cross-over Pharmacokinetic Study of SB204 in Acne Vulgaris

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1, Single-center, Double-blind, Randomized, Cross-over, Pharmacokinetics, Safety and Tolerability Study of SB204 8% (NVN1000 Gel) and Vehicle Gel

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: SB204
* Drug: Vehicle Gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB204<br>SB204 8% topically twice daily for 4 days and once on Day 5 | Drug: SB204<br>* SB204 Gel with hydrogel<br>* Other names: NVN1000;|
| Placebo Comparator: Vehicle Gel<br>Vehicle Gel topically twice daily for 4 days and once on Day 5 | Drug: Vehicle Gel<br>* Vehicle Gel with hydrogel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of nitrate and silicon | 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. | After single dose and multiple dose (Day 5) application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Physical examinations including vital signs, EKGs, and laboratory assessments (serum chemistry, hematology and urinalysis) will be performed at Screening and during the study. Adverse events will be collected throughout the study. | Safety will be assessed throughout the study duration (up to 7 weeks). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne