Back to resultsA Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NVN1000 4% Gel
Vehicle Gel
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Propionibacterium acnes, acne
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- KGL
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NVN1000 4% Gel
Vehicle Gel
Arm Description
NVN1000 4% Gel twice daily to the face for 2 weeks
Vehicle Gel twice daily to the face for 2 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety which includes reported adverse events, clinically significant changes in physical exam, and labs
Adverse events will be summarized by treatment group. Clinically significant changes in physical examination, including vital signs, over the treatment period will be reported as adverse events. Changes in laboratory results will be analyzed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01844739
Brief Title
A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel
Official Title
A Phase 1, Multiple-dose, Evaluator-blind, Randomized, Parallel Group Study Evaluating the Safety and Cutaneous Tolerability of SB204 (NVN1000 Gel) in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novan, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
In this single-center, vehicle gel-controlled, evaluator and subject blinded study, approximately 30 otherwise healthy adult subjects with elevated P. acnes counts will be randomized 2:1 to NVN1000 4% Gel or Vehicle Gel. The subjects will apply the test material twice daily to their face after washing. Subjects will be seen daily at the skin study center during the week and will apply their evening and weekend dose at home. Cutaneous tolerability will be assessed by the Investigator at Baseline, Week 1, and Week 2. Safety assessments include collection of adverse events, laboratory results, and clinically significant changes in physical examination. P. acnes counts will be obtained at Baseline, Week 1 and Week 2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Propionibacterium acnes, acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NVN1000 4% Gel
Arm Type
Experimental
Arm Description
NVN1000 4% Gel twice daily to the face for 2 weeks
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle Gel twice daily to the face for 2 weeks
Intervention Type
Drug
Intervention Name(s)
NVN1000 4% Gel
Other Intervention Name(s)
SB204
Intervention Description
Applied topically twice daily
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Other Intervention Name(s)
Placebo
Intervention Description
Applied topically twice daily
Primary Outcome Measure Information:
Title
Tolerability based on the cutaneous tolerability scores
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Safety which includes reported adverse events, clinically significant changes in physical exam, and labs
Description
Adverse events will be summarized by treatment group. Clinically significant changes in physical examination, including vital signs, over the treatment period will be reported as adverse events. Changes in laboratory results will be analyzed.
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Change in P. acnes counts
Description
P. acnes counts will be obtained by culture at Baseline, Week 1 and Week 2/end of treatment. The change in P. acnes counts over time will be analyzed.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce Rico, MD
Organizational Affiliation
Novan, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
KGL
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel
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