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

A Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled, Parallel Group, 3-arm Study Comparing the Efficacy, Tolerability and Safety of 2 Concentrations of NVN1000 Gel and Vehicle Gel Twice Daily in the Treatment of Acne Vulgaris.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01844752

Enrollment

153

Registered

2013-05-01

Start date

2013-04-30

Completion date

2013-11-30

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

acne

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 assessed over the course of the study.

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 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.

Interventions

DRUGNVN1000 1% Gel

Twice daily NVN1000 1% Gel for 12 weeks

DRUGNVN1000 4% Gel

Twice daily NVN1000 4% Gel for 12 weeks

DRUGVehicle Gel

Twice daily Vehicle Gel for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The absolute change from baseline in non-inflammatory lesion counts at Week 12	12 weeks	The absolute change from baseline in non-inflammatory lesion counts at Week 12

Secondary

Measure	Time frame	Description
The absolute change from baseline in inflammatory lesion counts at Week 12	12 weeks	The absolute change from baseline in inflammatory lesion counts at Week 12
Success on the Investigator Global Assessment (IGA) at Week 12	12 week	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.

Countries

Dominican Republic, Honduras, Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026