A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers

Acne Vulgaris Clinical Trial

Official title:

A Phase One, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN10000 Topical Gel in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755247
• Other study ID #: NI-AC004
• Status: Completed
• Phase: Phase 1
• Start date: November 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2019
• Source: Novan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase I, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers

Description:

This is a 3 day study to assess safety and tolerability of a new topical gel product, NVN1000 with and without the application of a commercially available moisturizer in approximately 15 healthy subjects. The test product will be applied to the forehead of healthy volunteers once daily for 3 days. One group of subjects will have a moisturizer applied to the same area 15 minutes after the test gel was applied and one group of subjects will be treated with the gel vehicle which does not contain the active product. The hypothesis is that the application of moisturizer will not effect safety or local tolerability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 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 Females > 18 years of age

• High degree of fluorescence of facial skin under Wood's lamp

Exclusion Criteria:

• Acute or chronic skin disorders

• Topical or systemic antibiotics within 4 weeks of study enrollment

• Use of medication that increases risk of methemoglobinemia or influences P. acnes counts

• Subjects with medical illnesses, anemia, elevated methemoglobin

• Women who are pregnant, nursing or planning a pregnancy

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Topical Gel Vehicle

• 8% NVN1000 Topical Gel

• 8% NVN1000 Topical Gel and moisturizer

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
Other	Propionibacterium acnes counts	P. acnes counts will be obtained at Baseline, Day 1, and Day 3. The change in P acnes counts over time by treatment group will be assessed.	3 days
Primary	Cutaneous tolerability	Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.	3 days
Secondary	Safety comparison	Assess safety through the comparison of adverse events between groups (lab assessments, physical exams and vital signs).	3 Days