Status:
COMPLETED
A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne
Lead Sponsor:
Novan, Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-40 years
Phase:
PHASE2
Brief Summary
This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and efficacy will be ass...
Detailed Description
This is a multi-center, evaluator and subject blinded, randomized, vehicle-controlled, parallel group, dose-ranging study to be conducted in approximately 150 subjects with acne vulgaris. Subjects who...
Eligibility Criteria
Inclusion
- Subjects with acne vulgaris and at least 20 but no more than 40 inflammatory lesions, 25-70 non-inflammatory lesions, no more than 2 nodules on the face
- Baseline IGA score of mild, moderate or severe
- Women of child-bearing potential must agree to use an effective method of birth control during the study and for 30 days after their final study visit
Exclusion
- Any dermatologic condition or other medical problem that could interfere with clinical evaluation or requires the use of topical or systemic therapy that make evaluations and lesion count inconclusive
- Female subjects who are pregnant, nursing, or considering becoming pregnant
- Methemoglobin \> 2% at baseline
- Clinically significant anemia at baseline
- Use of topical or systemic medications to treat acne
- Use of medications that make acne worse, associated with methemoglobinemia, or nitric oxide donors
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT01844752
Start Date
April 1 2013
End Date
November 1 2013
Last Update
November 19 2018
Active Locations (3)
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1
Instituto Dermatologico & Cirugia de Piel
Santo Domingo, Dominican Republic
2
Hospital Y Clinica Bendana
San Pedro Sula, Honduras
3
Hosptal Punta Pacifica
Panama City, Panama