Status:
COMPLETED
A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel
Lead Sponsor:
Novan, Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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%...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01844739
Start Date
April 1 2013
End Date
June 1 2013
Last Update
November 19 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
KGL
Broomall, Pennsylvania, United States, 19008