A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel
A Phase 1, Multiple-dose, Evaluator-blind, Randomized, Parallel Group Study Evaluating the Safety and Cutaneous Tolerability of SB204 (NVN1000 Gel) in Healthy Volunteers
1 other identifier
interventional
30
1 country
1
Brief Summary
This is a 2 week Phase 1 study of SB204 (NVN1000 Gel) in healthy adult volunteers with elevated Propionibacterium acnes (P. acnes) counts. Subjects will apply NVN1000 4% Gel or Vehicle Gel twice daily to their face. Assessments will include cutaneous tolerability, safety, and P. acnes counts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2013
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
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 29, 2013
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedNovember 19, 2018
November 1, 2018
2 months
April 29, 2013
November 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tolerability based on the cutaneous tolerability scores
Cutaneous tolerability assessments (erythema, scaling, dryness, pruritus, burning/stinging) will be summarized with frequency counts and percentages at each score category for Week 1 and Week 2.
2 weeks
Secondary Outcomes (1)
Safety which includes reported adverse events, clinically significant changes in physical exam, and labs
2 weeks
Other Outcomes (1)
Change in P. acnes counts
2 weeks
Study Arms (2)
NVN1000 4% Gel
EXPERIMENTALNVN1000 4% Gel twice daily to the face for 2 weeks
Vehicle Gel
PLACEBO COMPARATORVehicle Gel twice daily to the face for 2 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adult male or female volunteers
- If a woman of child-bearing potential, agrees to use effective method of birth control during the study and for 30 days after the final study visit
- Agree to refrain from use of antimicrobial topical products during study
You may not qualify if:
- Any skin disorders of acute or chronic nature including psoriasis, eczema, etc
- Female subjects who are pregnant, nursing, or planning to become pregnant
- Subjects who have used topical or systemic antibiotics, estrogens, drugs associated with methemoglobinemia, nitrate donors
- Subjects with baseline methemoglobin \> 2%
- Subjects with clinically significant anemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novan, Inc.lead
Study Sites (1)
KGL
Broomall, Pennsylvania, 19008, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joyce Rico, MD
Novan, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2013
First Posted
May 1, 2013
Study Start
April 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
November 19, 2018
Record last verified: 2018-11