NCT03436615

Brief Summary

This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose study to be conducted in non-immunocompromised subjects with molluscum contagiosum.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

18 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

January 24, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2018

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

February 6, 2018

Results QC Date

January 23, 2023

Last Update Submit

April 10, 2023

Conditions

Molluscum Contagiosum

Outcome Measures

Primary Outcomes (1)

  • Proportion of Subjects Achieving Complete Clearance at Week 12

    Percent (proportion) of subjects with complete clearance of all treatable MC at Week 12. This was measured by dividing the number of subjects who showed complete clearance by the number in that treatment group (this represents our primary outcome variable).

    12 weeks

Secondary Outcomes (5)

  • Proportion of Subjects Achieving Complete Clearance at Each Visit

    Week 1; Week 2; Week 4; Week 8; Week 12

  • Time to First Complete Clearance

    Week 12

  • Proportion of Subjects Achieving 75% Reduction at Each Visit

    Week 1, Week 2, Week 4, Week 8, Week 12

  • Mean Change in Molluscum Contagiosum at Each Visit

    Week 1, Week 2, Week 4, Week 8, Week 12

  • Percent Change in Molluscum Contagiosum at Each Visit

    Week 1, Week 2, Week 4, Week 8, Week 12

Study Arms (4)

SB206 4%

EXPERIMENTAL

SB206 4% topically twice daily

Drug: SB206 4%

SB206 8%

EXPERIMENTAL

SB206 8% topically twice daily

Drug: SB206 8%

SB206 12%

EXPERIMENTAL

SB206 12% topically once or twice daily

Drug: SB206 12%

Placebo (vehicle gel)

PLACEBO COMPARATOR

Vehicle Gel topically once or twice daily

Drug: Placebo

Interventions

SB206 4%DRUG

Twice daily

Also known as: NVN1000
SB206 4%
SB206 8%DRUG

Twice daily

Also known as: NVN1000
SB206 8%
SB206 12%DRUG

Once or twice daily

Also known as: NVN1000
SB206 12%
PlaceboDRUG

Once or twice daily

Also known as: Vehicle Gel
Placebo (vehicle gel)

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be 2 years of age or older, and in good general health;
  • Have signed written informed consent form by a parent or legal guardian (assent form where required);
  • Have between 3 and 70 MC at baseline, excluding periocular (within 2 cm circumference of the eye) and lesions on the labia and penis;
  • Females 10 years of age and older must have a negative urine pregnancy test prior to randomization;
  • Females 10 years of age and older must agree to use an effective method of birth control during the course of the study and for 30 days after their final study visit;
  • Be willing and able to follow study instructions and likely to complete all study requirements.

You may not qualify if:

  • Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive treatment;
  • Have agminated MC that could make it difficult to provide accurate lesion counts;
  • Have active atopic dermatitis with intense erythema and/or excoriations, that impact currently or could impact at any point during the study the ability to count MC lesions;
  • Have significant eczematous reactions or other skin disease surrounding MC that may impact the ability to count lesions;
  • Have received treatment with topical calcineurin inhibitors or steroids on MC or within 2 cm of MC lesions within 14 days prior to baseline;
  • Have received treatment for MC during the 14 days prior to baseline with podophyllotoxin, imiquimod, cantharidin, sinecatechins, topical retinoids, oral or topical zinc, or other homeopathic or OTC products including, but not limited to, Zymaderm and tea tree oil, cimetidine and other histamine H2 receptor antagonists;
  • Have received surgical procedures (cryotherapy, curettage, other) within 28 days prior to baseline;
  • Have MC only in periocular area;
  • Have MC only on the labia or penis;
  • Female subjects who are pregnant, planning a pregnancy or breastfeeding;
  • Have confirmed methemoglobin level of \>3.0% at Baseline using a pulse co-oximeter;
  • Have know hypersensitivity to any ingredients of SB206 or Vehicle Gel including excipients;
  • Have participated in a previous study with NVN1000;
  • Have participated in any other trial of an interventional investigational drug or device within 30 days or concurrent participation in another interventional research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Premier Site# 266

Scottsdale, Arizona, 85255, United States

Location

Premier Site# 260

Santa Ana, California, 92701, United States

Location

Premier Site# 257

Thornton, Colorado, 80233, United States

Location

Premier Site# 264

Doral, Florida, 33172, United States

Location

Premier Site# 116

Newnan, Georgia, 30263, United States

Location

Premier Site# 251

Indianapolis, Indiana, 46256, United States

Location

Premier Site# 253

Lenexa, Kansas, 66215, United States

Location

Premier Site# 117

Louisville, Kentucky, 40241, United States

Location

Premier Site# 182

Las Vegas, Nevada, 89129, United States

Location

Premier Site# 252

Norman, Oklahoma, 73071, United States

Location

Premier Site# 237

Gresham, Oregon, 97030, United States

Location

Premier Site# 259

Charleston, South Carolina, 29414, United States

Location

Premier Site# 255

Mt. Pleasant, South Carolina, 29464, United States

Location

Premier Site# 131

Houston, Texas, 77004, United States

Location

Premier Site# 167

Houston, Texas, 77030, United States

Location

Premier Site# 224

San Antonio, Texas, 78218, United States

Location

Premier Site# 256

Salt Lake City, Utah, 84124, United States

Location

Premier Site# 267

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Molluscum Contagiosum

Interventions

berdazimer sodium

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Cathy White, Vice President, Drug Development Operations
Organization
Novan
clinical@novan.com
9194858080

Study Officials

  • Tomoko Maeda-Chubachi, MD

    Novan, Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 19, 2018

Study Start

January 24, 2018

Primary Completion

November 3, 2018

Study Completion

November 3, 2018

Last Updated

May 6, 2023

Results First Posted

May 6, 2023

Record last verified: 2023-04

Locations

US(18)