A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NVN1000 1% Gel

NVN1000 1% Gel twice daily

Group Type EXPERIMENTAL

NVN1000 1% Gel

Intervention Type DRUG

Twice daily NVN1000 1% Gel for 12 weeks

NVN1000 4% Gel

NVN1000 4% Gel twice daily

Group Type EXPERIMENTAL

NVN1000 4% Gel

Intervention Type DRUG

Twice daily NVN1000 4% Gel for 12 weeks

Vehicle Gel

Vehicle Gel twice daily

Group Type PLACEBO_COMPARATOR

Vehicle Gel

Intervention Type DRUG

Twice daily Vehicle Gel for 12 weeks

Interventions

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NVN1000 1% Gel

Twice daily NVN1000 1% Gel for 12 weeks

Intervention Type DRUG

NVN1000 4% Gel

Twice daily NVN1000 4% Gel for 12 weeks

Intervention Type DRUG

Vehicle Gel

Twice daily Vehicle Gel for 12 weeks

Intervention Type DRUG

Other Intervention Names

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NVN1000 NVN1000 Comparator Gel

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No