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

Novan

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: 8% NVN1000 Topical Gel and moisturizer; Drug: 8% NVN1000 Topical Gel; Drug: Topical Gel Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01755247

NI-AC004

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups, including a placebo group

Topical Gel Vehicle

Placebo Comparator group

Description:

Once daily application of topical gel vehicle to forehead for 3 days

Treatment:

Drug: Topical Gel Vehicle

8% NVN1000 Topical Gel

Active Comparator group

Description:

Once daily application of 8% NVN1000 Topical Gel to the forehead for 3 days

Treatment:

Drug: 8% NVN1000 Topical Gel

8% NVN1000 Topical Gel and moisturizer

Active Comparator group

Description:

Once daily application of 8% NVN1000 Topical Gel to the forehead, followed 15 minutes later by application of a commercially available moisturizer

Treatment:

Drug: 8% NVN1000 Topical Gel and moisturizer