A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers
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
1 other identifier
interventional
15
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 18, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedSeptember 10, 2019
May 1, 2019
Same day
December 18, 2012
September 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cutaneous tolerability
Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.
3 days
Secondary Outcomes (1)
Safety comparison
3 Days
Other Outcomes (1)
Propionibacterium acnes counts
3 days
Study Arms (3)
Topical Gel Vehicle
PLACEBO COMPARATOROnce daily application of topical gel vehicle to forehead for 3 days
8% NVN1000 Topical Gel
ACTIVE COMPARATOROnce daily application of 8% NVN1000 Topical Gel to the forehead for 3 days
8% NVN1000 Topical Gel and moisturizer
ACTIVE COMPARATOROnce daily application of 8% NVN1000 Topical Gel to the forehead, followed 15 minutes later by application of a commercially available moisturizer
Interventions
Eligibility Criteria
You may qualify if:
- Healthy Male and Females \> 18 years of age
- High degree of fluorescence of facial skin under Wood's lamp
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novan, Inc.lead
Study Sites (1)
KGL, Inc
Broomall, Pennsylvania, 19008, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James J Leyden
KGL, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2012
First Posted
December 24, 2012
Study Start
November 1, 2012
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
September 10, 2019
Record last verified: 2019-05