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OpenTrials
Completed

NCT Number: NCT01694810

Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

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).

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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 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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

2% NVN1000 Topical Gel

Drug

2% NVN1000 Topical Gel once daily for 4 weeks

Other names: NVN1000

4% NVN1000 Topical Gel

Drug

4% NVN1000 4% Topical Gel applied once daily 4 weeks

Other names: NVN1000

8% NVN1000 Topical Gel

Drug

8% NVN1000 Topical Gel applied once daily for 4 weeks

Other names: NVN1000

Vehicle Topical Gel

Drug

Vehicle Topical Gel applied once daily

Other names: Vehicle

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novan, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 27, 2012
Registry last updated
Jan 30, 2020

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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