Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

A Phase 1 Multiple Dose, Single-Center, Observer-Blind Parallel Group Study Evaluating Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers

The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes).

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: 2% NVN1000 Topical Gel; Drug: 4% NVN1000 Topical Gel; Drug: Vehicle Topical Gel; Drug: 8% NVN1000 Topical Gel

Detailed Description

This is a single center, observer blinded, randomized, multiple dose study with 3 doses of NVN1000 and vehicle applied once daily for 4 weeks. There are 4 arms to the study (3 active and 1 vehicle).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female volunteers
• Age 18 or older
• High degree of fluorescence of facial skin under Wood's lamp

Exclusion Criteria:

• Acute or chronic skin disorders
• Use of topical or systemic antibiotics within 4 weeks of study
• Concomitant use of nitroglycerin or other nitric oxide donor drugs
• Females who are pregnant, planning pregnancy or breast feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2% NVN1000 Topical Gel; 2% NVN1000 Topical Gel once daily for 4 weeks	Drug: 2% NVN1000 Topical Gel; 2% NVN1000 Topical Gel once daily for 4 weeks; Other Names: NVN1000
EXPERIMENTAL: 4% NVN1000 Topical Gel; 4% NVN1000 4% Topical Gel once daily for 4 weeks	Drug: 4% NVN1000 Topical Gel; 4% NVN1000 4% Topical Gel applied once daily 4 weeks; Other Names: NVN1000
PLACEBO_COMPARATOR: Vehicle Topical Gel; Vehicle Topical Gel once daily for 4 weeks	Drug: Vehicle Topical Gel; Vehicle Topical Gel applied once daily; Other Names: Vehicle
EXPERIMENTAL: 8% NVN1000 Topical Gel; 8% NVN1000 8% Topical Gel applied once daily for 4 weeks	Drug: 8% NVN1000 Topical Gel; 8% NVN1000 Topical Gel applied once daily for 4 weeks; Other Names: NVN1000

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cutaneous tolerability Evaluation	Cutaneous tolerability evaluations to include erythema, scaling, dryness, puritus and burning/stinging using a 4-category scale with scores ranging from 0-3 (0=none, 1=mild, 2=moderate, 3 - severe).	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment	Comparison of adverse events between groups.	4 weeks
Safety Assessment	Change from baseline in HCT (L/L)	4 weeks
Safety Assessment	Change from baseline in HGB, MCHC (g/L)	4 weeks
Safety Assessment	Change from baseline in % methemoglobin (%)	4 weeks
Safety Assessment	Change from baseline in % Basophils (%)	4 weeks
Safety Assessment	Change from baseline in % Eosinophils (%)	4 weeks
Safety Assessment	Change from baseline in % Lymphocytes (%)	4 weeks
Safety Assessment	Change from baseline in MCH (pg)	4 weeks
Safety Assessment	Change from baseline in MCV, MPV (fL)	4 weeks
Safety Assessment	Change from baseline in % Monocytes (%)	4 weeks
Safety Assessment	Change from baseline in % Neutrophils (%)	4 weeks
Safety Assessment	Change from baseline in Platelet Count, WBC (10 ^ 9/L)	4 weeks
Safety Assessment	Change from baseline in % RDW (%)	4 weeks
Safety Assessment	Change from baseline in RBC (10 ^ 12/L)	4 weeks
Safety Assessment	Change from baseline in Albumin, Protein, Total (g/L)	4 weeks
Safety Assessment	Change from baseline in Alkaline Phosphatase, ALT, AST, (U/L)	4 weeks
Safety Assessment	Change from baseline in Bicarbonate, Bun, Calcium, Chloride, Glucose, Phosphorus, Potassium, Sodium (mmol/L)	4 weeks
Safety Assessment	Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L)	4 weeks

Collaborators and Investigators

• Sponsor: Novan, Inc.
• Investigators: Principal Investigator: James J Leyden, MD, KGL, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (ESTIMATE): September 27, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: acne vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: NI-AC002