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Completed

NCT Number: NCT01755247

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

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

KGL, Inc

Broomall, Pennsylvania, 19008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical Gel Vehicle

Drug

Other names: Vehicle

8% NVN1000 Topical Gel

Drug

Other names: NVN1000 Topical Gel

8% NVN1000 Topical Gel and moisturizer

Drug

Other names: NVN1000 plus moisturizer

Primary outcomes

  1. Cutaneous tolerability

    Time frame: 3 days

    Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.

Secondary outcomes

  1. Safety comparison

    Time frame: 3 Days

    Assess safety through the comparison of adverse events between groups (lab assessments, physical exams and vital signs).

Other outcomes

  1. Propionibacterium acnes counts

    Time frame: 3 days

    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.

Sponsors and collaborators

Lead sponsor

Novan, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 24, 2012
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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