Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris
This study has been completed.
Sponsor:
Novan, Inc.
Information provided by (Responsible Party):
Novan, Inc.
ClinicalTrials.gov Identifier:
NCT01556698
First received: March 14, 2012
Last updated: March 15, 2012
Last verified: March 2012
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Purpose
The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris Acne |
Drug: NVN1000 Topical Gel Drug: Topical Gel Vehicle |
Phase 1 Phase 2 |
| Study Type: | Interventional |
Resource links provided by NLM:
Further study details as provided by Novan, Inc.:
| Study Start Date: | July 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: NVN1000 Topical Gel | Drug: NVN1000 Topical Gel |
| Placebo Comparator: Topical Gel Vehicle |
Drug: Topical Gel Vehicle
Placebo
|
Eligibility| Ages Eligible for Study: | 12 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Baseline IGA score of moderate (3) or severe (4)
- Minimum of 20 but no more than 40 facial inflammatory lesions
- Minimum of 20 but not more than 60 facial non-inflammatory lesions
- No more than 2 facial nodules
Exclusion Criteria:
- Dermatological conditions on the face that could interfere with clinical evaluations
- Underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
- History of experiencing significant burning or stinging when applying any facial treatment
- Female subjects, if they are pregnant,nursing mothers, or planning to become pregnant during the study
- Have used estrogens or oral contraceptives for less than 90 days immediately preceding the Baseline visit, discontinued use of estrogens or oral contraceptives less than 90 days prior to Baseline,or planning to begin or discontinue use of this therapy during the treatment period
- Have used medications and/or vitamins which are reported to exacerbate acne during the 180 days immediately preceding the Baseline visit
- Use concomitantly over-the-counter (OTC) products that contain ingredients such as benzoyl peroxide,salicylic acid,alpha-hydroxy acid,retinol or glycolic acids
- Have not undergone the specified washouts for topical preparations,systemic medications and procedures noted in the protocol
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Novan, Inc. |
| ClinicalTrials.gov Identifier: | NCT01556698 History of Changes |
| Other Study ID Numbers: | NI-AC001 |
| Study First Received: | March 14, 2012 |
| Last Updated: | March 15, 2012 |
| Health Authority: | Dominican Republic: Consejo Nacional de Bioetica en Salud |
Keywords provided by Novan, Inc.:
|
Acne Vulgaris Acne |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |
ClinicalTrials.gov processed this record on June 17, 2013