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Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
2% NVN1000 Topical Gel
4% NVN1000 Topical Gel
8% NVN1000 Topical Gel
Vehicle Topical Gel
Sponsored by
Novan, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • KGL, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

2% NVN1000 Topical Gel

4% NVN1000 Topical Gel

Vehicle Topical Gel

8% NVN1000 Topical Gel

Arm Description

2% NVN1000 Topical Gel once daily for 4 weeks

4% NVN1000 4% Topical Gel once daily for 4 weeks

Vehicle Topical Gel once daily for 4 weeks

8% NVN1000 8% Topical Gel applied once daily for 4 weeks

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2012
Last Updated
January 28, 2020
Sponsor
Novan, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01694810
Brief Title
Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
Official Title
A Phase 1 Multiple Dose, Single-Center, Observer-Blind Parallel Group Study Evaluating Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novan, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2% NVN1000 Topical Gel
Arm Type
Experimental
Arm Description
2% NVN1000 Topical Gel once daily for 4 weeks
Arm Title
4% NVN1000 Topical Gel
Arm Type
Experimental
Arm Description
4% NVN1000 4% Topical Gel once daily for 4 weeks
Arm Title
Vehicle Topical Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle Topical Gel once daily for 4 weeks
Arm Title
8% NVN1000 Topical Gel
Arm Type
Experimental
Arm Description
8% NVN1000 8% Topical Gel applied once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
2% NVN1000 Topical Gel
Other Intervention Name(s)
NVN1000
Intervention Description
2% NVN1000 Topical Gel once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
4% NVN1000 Topical Gel
Other Intervention Name(s)
NVN1000
Intervention Description
4% NVN1000 4% Topical Gel applied once daily 4 weeks
Intervention Type
Drug
Intervention Name(s)
8% NVN1000 Topical Gel
Other Intervention Name(s)
NVN1000
Intervention Description
8% NVN1000 Topical Gel applied once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle Topical Gel
Other Intervention Name(s)
Vehicle
Intervention Description
Vehicle Topical Gel applied once daily
Primary Outcome Measure Information:
Title
Cutaneous tolerability Evaluation
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Safety Assessment
Description
Comparison of adverse events between groups.
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in HCT (L/L)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in HGB, MCHC (g/L)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in % methemoglobin (%)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in % Basophils (%)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in % Eosinophils (%)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in % Lymphocytes (%)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in MCH (pg)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in MCV, MPV (fL)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in % Monocytes (%)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in % Neutrophils (%)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in Platelet Count, WBC (10 ^ 9/L)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in % RDW (%)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in RBC (10 ^ 12/L)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in Albumin, Protein, Total (g/L)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in Alkaline Phosphatase, ALT, AST, (U/L)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in Bicarbonate, Bun, Calcium, Chloride, Glucose, Phosphorus, Potassium, Sodium (mmol/L)
Time Frame
4 weeks
Title
Safety Assessment
Description
Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James J Leyden, MD
Organizational Affiliation
KGL, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
KGL, Inc
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States

12. IPD Sharing Statement

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Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

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