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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01755247
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 24, 2012
Last Update Posted Date January 13, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Cutaneous tolerability [ Time Frame: 3 days ]
Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01755247 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Safety [ Time Frame: 3 Days ]
Safety assessments include the change from baseline in percent methemoglobin, adverse events, and physical exams, including vital signs.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 18, 2012)
Propionobactium 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers
Official Title  ICMJE A Phase One, Single-Center, Open-Label, Randomized, Parllel Group, 3 Day Study Evaluating the Safety and Cutaneous Toleraility of NVN10000 Topical Gel in Healthy Volunteers
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Topical Gel Vehicle
  • Drug: 8% NVN1000 Topical Gel
  • Drug: 8% NVN1000 Topical Gel and moisturizer
Study Arms  ICMJE
  • Placebo Comparator: Topical Gel Vehicle
    Once daily application of topical gel vehicle to forehead for 3 days
    Intervention: Drug: Topical Gel Vehicle
  • Active Comparator: 8% NVN1000 Topical Gel
    Once daily application of 8% NVN1000 Topical Gel to the forehead for 3 days
    Intervention: Drug: 8% NVN1000 Topical Gel
  • Active Comparator: 8% NVN1000 Topical Gel and moisturizer
    Once daily application of 8% NVN1000 Topical Gel to the forehead, followed 15 minutes later by application of a commercially available moisturizer
    Intervention: Drug: 8% NVN1000 Topical Gel and moisturizer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2012)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755247
Other Study ID Numbers  ICMJE NI-AC004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novan, Inc.
Study Sponsor  ICMJE Novan, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James J Leyden KGL, Inc.
PRS Account Novan, Inc.
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP