A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Vehicle Gel; Drug: NVN1000 4% Gel

• Registration Number: NCT01844739
• Lead Sponsor: Novan, Inc.

Brief Summary

This is a 2 week Phase 1 study of SB204 (NVN1000 Gel) in healthy adult volunteers with elevated Propionibacterium acnes (P. acnes) counts. Subjects will apply NVN1000 4% Gel or Vehicle Gel twice daily to their face. Assessments will include cutaneous tolerability, safety, and P. acnes counts.

Detailed Description

In this single-center, vehicle gel-controlled, evaluator and subject blinded study, approximately 30 otherwise healthy adult subjects with elevated P. acnes counts will be randomized 2:1 to NVN1000 4% Gel or Vehicle Gel. The subjects will apply the test material twice daily to their face after washing. Subjects will be seen daily at the skin study center during the week and will apply their evening and weekend dose at home. Cutaneous tolerability will be assessed by the Investigator at Baseline, Week 1, and Week 2. Safety assessments include collection of adverse events, laboratory results, and clinically significant changes in physical examination. P. acnes counts will be obtained at Baseline, Week 1 and Week 2.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-05-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy adult male or female volunteers
• If a woman of child-bearing potential, agrees to use effective method of birth control during the study and for 30 days after the final study visit
• Agree to refrain from use of antimicrobial topical products during study

Exclusion Criteria

• Any skin disorders of acute or chronic nature including psoriasis, eczema, etc
• Female subjects who are pregnant, nursing, or planning to become pregnant
• Subjects who have used topical or systemic antibiotics, estrogens, drugs associated with methemoglobinemia, nitrate donors
• Subjects with baseline methemoglobin > 2%
• Subjects with clinically significant anemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle Gel	Vehicle Gel	Vehicle Gel twice daily to the face for 2 weeks
NVN1000 4% Gel	NVN1000 4% Gel	NVN1000 4% Gel twice daily to the face for 2 weeks

Primary Outcome Measures

Name	Time	Method
Tolerability based on the cutaneous tolerability scores	2 weeks	Cutaneous tolerability assessments (erythema, scaling, dryness, pruritus, burning/stinging) will be summarized with frequency counts and percentages at each score category for Week 1 and Week 2.

Secondary Outcome Measures

Name	Time	Method
Safety which includes reported adverse events, clinically significant changes in physical exam, and labs	2 weeks	Adverse events will be summarized by treatment group. Clinically significant changes in physical examination, including vital signs, over the treatment period will be reported as adverse events. Changes in laboratory results will be analyzed.

Trial Locations

Locations (1)

KGL; 🇺🇸 Broomall, Pennsylvania, United States