NCT01844752

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_2

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

April 29, 2013

Last Update Submit

November 15, 2018

Conditions

Acne Vulgaris

Keywords

acne

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

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

    12 weeks

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

    12 week

Study Arms (3)

NVN1000 1% Gel

EXPERIMENTAL

NVN1000 1% Gel twice daily

Drug: NVN1000 1% Gel

NVN1000 4% Gel

EXPERIMENTAL

NVN1000 4% Gel twice daily

Drug: NVN1000 4% Gel

Vehicle Gel

PLACEBO COMPARATOR

Vehicle Gel twice daily

Drug: Vehicle Gel

Interventions

NVN1000 1% GelDRUG

Twice daily NVN1000 1% Gel for 12 weeks

Also known as: NVN1000
NVN1000 1% Gel
NVN1000 4% GelDRUG

Twice daily NVN1000 4% Gel for 12 weeks

Also known as: NVN1000
NVN1000 4% Gel
Vehicle GelDRUG

Twice daily Vehicle Gel for 12 weeks

Also known as: Comparator Gel
Vehicle Gel

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Instituto Dermatologico & Cirugia de Piel

Santo Domingo, Dominican Republic

Location

Hospital Y Clinica Bendana

San Pedro Sula, Honduras

Location

Hosptal Punta Pacifica

Panama City, Panama

Location

Related Publications (1)

  • 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.

    PMID: 27672413DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

berdazimer sodiumGels

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Joyce Rico, MD

    Novan, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 1, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 19, 2018

Record last verified: 2018-11

Locations

PA(1)HO(1)DO(1)