Acne Vulgaris
Conditions
Keywords
Propionibacterium acnes, acne
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.
Interventions
DRUGNVN1000 4% Gel
Applied topically twice daily
DRUGVehicle Gel
Applied topically twice daily
Sponsors
Novan, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability based on the cutaneous tolerability scores | 2 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety which includes reported adverse events, clinically significant changes in physical exam, and labs | 2 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in P. acnes counts | 2 weeks | 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. |
Countries
United States
Outcome results
None listed