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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

NVN1000 1% Gel

NVN1000 4% Gel

Vehicle Gel

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Instituto Dermatologico & Cirugia de Piel
Hospital Y Clinica Bendana
Hosptal Punta Pacifica

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

NVN1000 1% Gel

NVN1000 4% Gel

Vehicle Gel

Arm Description

NVN1000 1% Gel twice daily

NVN1000 4% Gel twice daily

Vehicle Gel twice daily

Outcomes

Primary Outcome Measures

The absolute change from baseline in non-inflammatory lesion counts at Week 12

Secondary Outcome Measures

The absolute change from baseline in inflammatory lesion counts at Week 12

Success on the Investigator Global Assessment (IGA) at Week 12

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.

Full Information

NCT ID

NCT01844752

First Posted

April 29, 2013

Last Updated

November 15, 2018

Sponsor

Novan, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01844752

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novan, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

Keywords

acne

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

153 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NVN1000 1% Gel

Arm Type

Experimental

Arm Description

NVN1000 1% Gel twice daily

Arm Title

NVN1000 4% Gel

Arm Type

Experimental

Arm Description

NVN1000 4% Gel twice daily

Arm Title

Vehicle Gel

Arm Type

Placebo Comparator

Arm Description

Vehicle Gel twice daily

Intervention Type

Drug

Intervention Name(s)

NVN1000 1% Gel

Other Intervention Name(s)

NVN1000

Intervention Description

Twice daily NVN1000 1% Gel for 12 weeks

Intervention Type

Drug

Intervention Name(s)

NVN1000 4% Gel

Other Intervention Name(s)

NVN1000

Intervention Description

Twice daily NVN1000 4% Gel for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Vehicle Gel

Other Intervention Name(s)

Comparator Gel

Intervention Description

Twice daily Vehicle Gel for 12 weeks

Primary Outcome Measure Information:

Title

The absolute change from baseline in non-inflammatory lesion counts at Week 12

Description

The absolute change from baseline in non-inflammatory lesion counts at Week 12

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

The absolute change from baseline in inflammatory lesion counts at Week 12

Description

The absolute change from baseline in inflammatory lesion counts at Week 12

Time Frame

12 weeks

Title

Success on the Investigator Global Assessment (IGA) at Week 12

Description

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.

Time Frame

12 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joyce Rico, MD

Organizational Affiliation

Novan, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Instituto Dermatologico & Cirugia de Piel

City

Santo Domingo

Country

Dominican Republic

Facility Name

Hospital Y Clinica Bendana

City

San Pedro Sula

Country

Honduras

Facility Name

Hosptal Punta Pacifica

City

Panama City

Country

Panama

12. IPD Sharing Statement

Citations:

PubMed Identifier

27672413

Citation

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.

Results Reference

derived

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

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