A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel

A Phase 1, Multiple-dose, Evaluator-blind, Randomized, Parallel Group Study Evaluating the Safety and Cutaneous Tolerability of SB204 (NVN1000 Gel) in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: NVN1000 4% Gel; Drug: Vehicle Gel

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • KGL

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NVN1000 4% Gel; NVN1000 4% Gel twice daily to the face for 2 weeks	Drug: NVN1000 4% Gel; Applied topically twice daily; Other Names: SB204
Placebo Comparator: Vehicle Gel; Vehicle Gel twice daily to the face for 2 weeks	Drug: Vehicle Gel; Applied topically twice daily; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability based on the cutaneous tolerability scores	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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety which includes reported adverse events, clinically significant changes in physical exam, and labs	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.	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in P. acnes counts	P. acnes counts will be obtained by culture at Baseline, Week 1 and Week 2/end of treatment. The change in P. acnes counts over time will be analyzed.	2 weeks

Collaborators and Investigators

• Sponsor: Novan, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: April 29, 2013
• First Posted (Estimate): May 1, 2013

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: acne; Propionibacterium acnes
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: NI-AC006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No