NCT02665260

Brief Summary

The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids

Trial Health

100
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2012

Typical duration for phase_2

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

July 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2015

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 5, 2017

Completed
Last Updated

May 5, 2017

Status Verified

March 1, 2017

Enrollment Period

3.3 years

First QC Date

December 31, 2015

Results QC Date

December 6, 2016

Last Update Submit

March 23, 2017

Conditions

Molluscum Contagiosum

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Who Achieve Complete Clearance at 6 Weeks

    Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)

    6 weeks

Secondary Outcomes (1)

  • Number of Subjects Who Experienced an Adverse Event

    33 weeks

Study Arms (4)

Cantharidin with occlusion

ACTIVE COMPARATOR

Cantharidin 0.7% topical with occlusion

Drug: CantharidinDevice: Gauze occlusion bandage

Cantharidin without occlusion

EXPERIMENTAL

Cantharidin 0.7% topical without occlusion

Drug: Cantharidin

Placebo with occlusion

PLACEBO COMPARATOR

Placebo topical with occlusion

Drug: PlaceboDevice: Gauze occlusion bandage

Placebo without occlusion

PLACEBO COMPARATOR

Placebo topical without occlusion

Drug: Placebo

Interventions

CantharidinDRUG

cantharidin 0.7% topical liquid

Also known as: 2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione
Cantharidin with occlusionCantharidin without occlusion
PlaceboDRUG

Placebo topical liquid

Also known as: flexible collodion
Placebo with occlusionPlacebo without occlusion
Gauze occlusion bandageDEVICE

Gauze occlusion bandage with adhesive tape

Cantharidin with occlusionPlacebo with occlusion

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years
  • Healthy
  • \<50 molluscum contagiosum lesions

You may not qualify if:

  • Immunosuppressed
  • Oral corticosteroids
  • Sexually active/pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Molluscum Contagiosum

Interventions

Cantharidin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Steven Cohen
Organization
Montefiore Medical center
dermpharmeinstein@gmail.com
718-920-8470

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 31, 2015

First Posted

January 27, 2016

Study Start

July 1, 2012

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

May 5, 2017

Results First Posted

May 5, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share