Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT01694810
• Recruitment Status: Completed
• First Posted: September 27, 2012
• Last Update Posted: January 30, 2020
• Sponsor: Novan, Inc.
• Information provided by (Responsible Party): Novan, Inc.

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).

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: 2% NVN1000 Topical Gel; Drug: 4% NVN1000 Topical Gel; Drug: 8% NVN1000 Topical Gel; Drug: Vehicle Topical Gel	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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 Start Date: September 2012
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: November 2012

Arms and Interventions

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 Name: 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 Name: 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 Name: 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 Name: NVN1000

Outcome Measures

Primary Outcome Measures :

1. Cutaneous tolerability Evaluation [ Time Frame: 4 weeks ]
   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 :

1. Safety Assessment [ Time Frame: 4 weeks ]
   Comparison of adverse events between groups.
2. Safety Assessment [ Time Frame: 4 weeks ]
   Change from baseline in HCT (L/L)
3. Safety Assessment [ Time Frame: 4 weeks ]
   Change from baseline in HGB, MCHC (g/L)
4. Safety Assessment [ Time Frame: 4 weeks ]
   Change from baseline in % methemoglobin (%)
5. Safety Assessment [ Time Frame: 4 weeks ]
   Change from baseline in % Basophils (%)
6. Safety Assessment [ Time Frame: 4 weeks ]
   Change from baseline in % Eosinophils (%)
7. Safety Assessment [ Time Frame: 4 weeks ]
   Change from baseline in % Lymphocytes (%)
8. Safety Assessment [ Time Frame: 4 weeks ]
   Change from baseline in MCH (pg)
9. Safety Assessment [ Time Frame: 4 weeks ]
   Change from baseline in MCV, MPV (fL)
10. Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in % Monocytes (%)
11. Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in % Neutrophils (%)
12. Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in Platelet Count, WBC (10 ^ 9/L)
13. Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in % RDW (%)
14. Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in RBC (10 ^ 12/L)
15. Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in Albumin, Protein, Total (g/L)
16. Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in Alkaline Phosphatase, ALT, AST, (U/L)
17. Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in Bicarbonate, Bun, Calcium, Chloride, Glucose, Phosphorus, Potassium, Sodium (mmol/L)
18. Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Pennsylvania

KGL, Inc

Broomall, Pennsylvania, United States, 19008

Sponsors and Collaborators

Novan, Inc.

Investigators

• Principal Investigator: James J Leyden, MD; KGL, Inc.

More Information

• Responsible Party: Novan, Inc.
• ClinicalTrials.gov Identifier: NCT01694810
• Other Study ID Numbers: NI-AC002
• First Posted: September 27, 2012
• Last Update Posted: January 30, 2020
• Last Verified: January 2020

Keywords provided by Novan, Inc.:

acne vulgaris

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases