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

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

This study will identify how much (if any) drug is absorbed from the skin of subjects with acne vulgaris after topical application of SB204.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: SB204; Drug: Vehicle Gel

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • West Bend, Wisconsin, United States, 53095
      • Spaulding Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Novan, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimate): June 16, 2014

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: NI-AC101