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

September 9, 2019 updated by: Novan, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Broomall, Pennsylvania, United States, 19008
        • KGL, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Topical Gel Vehicle
Once daily application of topical gel vehicle to forehead for 3 days
Drug: Topical Gel Vehicle
Other Names:
  • 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
Other Names:
  • 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
Other Names:
  • NVN1000 plus moisturizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutaneous tolerability
Time Frame: 3 days
Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety comparison
Time Frame: 3 Days
Assess safety through the comparison of adverse events between groups (lab assessments, physical exams and vital signs).
3 Days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novan, Inc.

Investigators

  • Principal Investigator: James J Leyden, KGL, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (ESTIMATE)

December 24, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI-AC004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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