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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.
ClinicalTrials.gov Identifier:
NCT01755247
First received: December 18, 2012
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: Topical Gel Vehicle
Drug: 8% NVN1000 Topical Gel
Drug: 8% NVN1000 Topical Gel and moisturizer
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novan, Inc.:

Primary Outcome Measures:
  • Cutaneous tolerability [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.


Secondary Outcome Measures:
  • Safety [ Time Frame: 3 Days ] [ Designated as safety issue: Yes ]
    Safety assessments include the change from baseline in percent methemoglobin, adverse events, and physical exams, including vital signs.


Other Outcome Measures:
  • Propionobactium acnes counts [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: November 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Topical Gel Vehicle
Once daily application of topical gel vehicle to forehead for 3 days
Drug: Topical Gel Vehicle
Active Comparator: 8% NVN1000 Topical Gel
Once daily application of 8% NVN1000 Topical Gel to the forehead for 3 days
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
Drug: 8% NVN1000 Topical Gel and moisturizer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755247

Locations
United States, Pennsylvania
KGL, Inc
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
Novan, Inc.
Investigators
Principal Investigator: James J Leyden KGL, Inc.
  More Information

No publications provided

Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT01755247     History of Changes
Other Study ID Numbers: NI-AC004
Study First Received: December 18, 2012
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novan, Inc.:
acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on September 22, 2014