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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 assessed over the course of the study.
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 satisfy the entry criteria at the Baseline visit will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel in a 1:1:1 ratio. Efficacy assessments will include inflammatory and non-inflammatory lesion counts and investigator global assessments (IGA). Tolerability and safety assessments include cutaneous tolerability evaluation, adverse event collection, physical exams, and laboratory studies. Subjects will return for post-baseline evaluation at Weeks 2, 4, 8, and 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVN1000 1% Gel | Experimental | NVN1000 1% Gel twice daily |
|
| NVN1000 4% Gel | Experimental | NVN1000 4% Gel twice daily |
|
| Vehicle Gel | Placebo Comparator | Vehicle Gel twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVN1000 1% Gel | Drug | Twice daily NVN1000 1% Gel for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The absolute change from baseline in non-inflammatory lesion counts at Week 12 | The absolute change from baseline in non-inflammatory lesion counts at Week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The absolute change from baseline in inflammatory lesion counts at Week 12 | The absolute change from baseline in inflammatory lesion counts at Week 12 | 12 weeks |
| Success on the Investigator Global Assessment (IGA) at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joyce Rico, MD | Novan, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dermatologico & Cirugia de Piel | Santo Domingo | Dominican Republic | ||||
| Hospital Y Clinica Bendana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27672413 | Derived | Baldwin H, Blanco D, McKeever C, Paz N, Vasquez YN, Quiring J, Enloe C, De Leon E, Stasko N. Results of a Phase 2 Efficacy and Safety Study with SB204, an Investigational Topical Nitric Oxide-releasing Drug for the Treatment of Acne Vulgaris. J Clin Aesthet Dermatol. 2016 Aug;9(8):12-8. Epub 2016 Aug 1. |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C000709171 | berdazimer sodium |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| NVN1000 4% Gel | Drug | Twice daily NVN1000 4% Gel for 12 weeks |
|
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| Vehicle Gel | Drug | Twice daily Vehicle Gel for 12 weeks |
|
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Analysis of the dichotomized IGA scores (success vs failure) at Week 12. "Success" is defined as a score of "clear" or "almost clear" and a 2 point improvement in the IGA score from Baseline.
| 12 week |
| San Pedro Sula |
| Honduras |
| Hosptal Punta Pacifica | Panama City | Panama |