Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris

Study Overview
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Brief Summary
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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.

Detailed Description
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The objective of this study is to evaluate the tolerability, safety and efficacy of once daily application of NVN1000 Topical Gel for 8 weeks in comparison with its vehicle in subjects with moderate to severe acne.

Official Title
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Single-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison, Proof of Concept Study Comparing the Tolerability, Safety and Efficacy of NVN1000 Topical Gel Gel Vehicle in the Treatment of Moderate to Severe Acne

Conditions
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Acne Vulgaris, Acne

Intervention / Treatment
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* Drug: NVN1000
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVN1000 Gel<br>NVN1000 Gel topically applied one daily at bedtime for 8 weeks | Drug: NVN1000<br> <br> * Other names: Nitric Oxide 0.3%;|
| Placebo Comparator: Vehicle Gel<br>Vehicle Gel topically applied once daily at bedtime for 8 weeks | Drug: Vehicle<br>* Placebo<br>* Other names: Vehicle Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne Vulgaris, Acne