Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694810
• Other study ID #: NI-AC002
• Status: Completed
• Phase: Phase 1
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2020
• Source: Novan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• 2% NVN1000 Topical Gel
2% NVN1000 Topical Gel once daily for 4 weeks
• 4% NVN1000 Topical Gel
4% NVN1000 4% Topical Gel applied once daily 4 weeks
• 8% NVN1000 Topical Gel
8% NVN1000 Topical Gel applied once daily for 4 weeks
• Vehicle Topical Gel
Vehicle Topical Gel applied once daily

Locations

Country	Name	City	State
United States	KGL, Inc	Broomall	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novan, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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