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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164084
• Other study ID #: NI-AC101
• Status: Completed
• Phase: Phase 1
• First received: June 12, 2014
• Last updated: April 2, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Novan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• SB204
SB204 Gel with hydrogel
• Vehicle Gel
Vehicle Gel with hydrogel

Locations

Country	Name	City	State
United States	Spaulding Clinical Research, LLC	West Bend	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Novan, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tolerability	During the study, cutaneous tolerability assessments will be made at Day 1 and at the end of each treatment period (Day 5). Erythema, dryness, scaling, stinging/burning and itching will be assessed on a four point scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.	During both treatment periods, through last day of treatment.	Yes
Primary	Pharmacokinetics of nitrate and silicon	Standard PK parameters including area under the curve (AUC) 0-8, 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	No
Secondary	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).	Yes