NCT01084824

Brief Summary

The purpose of the study was to see if liquid nitrogen, a commonly used treatment for warts, is more effective if it is used alone, or if it is more effective if combined with cantharidin, a topical treatment also commonly used for warts (verruca vulgaris).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

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

June 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
Last Updated

March 11, 2010

Status Verified

March 1, 2010

Enrollment Period

1 year

First QC Date

March 10, 2010

Last Update Submit

March 10, 2010

Conditions

Verruca Vulgaris

Keywords

WartsVerruca vulgarisLiquid NitrogenCantharidincombination treatment

Outcome Measures

Primary Outcomes (1)

  • Percentage of common warts cleared

    Percentage of treated warts cleared with treatment, as measured with dermatoscopic examination, after 12 weeks.

    12 weeks

Study Arms (2)

Liquid nitrogen and canthardin

ACTIVE COMPARATOR

Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterwards.

Drug: Liquid nitrogen and cantharidin

Liquid nitrogen and placebo

PLACEBO COMPARATOR

Liquid nitrogen applied to wart(s) then placebo vehicle afterwards.

Drug: Liquid nitrogen and topical placebo

Interventions

Liquid nitrogen and cantharidinDRUG

Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterward.

Liquid nitrogen and canthardin
Liquid nitrogen and topical placeboDRUG

Liquid nitrogen applied to wart(s), then placebo vehicle applied thereafter.

Liquid nitrogen and placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • common warts on non-genital, non-facial skin
  • otherwise healthy
  • between 18-65 and able to give informed consent
  • capable of tolerating treatment

You may not qualify if:

  • Ill-health
  • Poor tolerance or sensitivity to treatments in study
  • \<18 years old; \>65 years old
  • verruca plana or condyloma acuminata
  • immunosuppression or immune dysfunction
  • significant peripheral vascular disease
  • significant sensitivity to cold
  • epidermodysplasia verruciformis
  • mosaiform warts or periungual warts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Idaho Dermatology

Coeur d'Alene, Idaho, 83814, United States

Location

Related Publications (3)

  • Berth-Jones J, Bourke J, Eglitis H, Harper C, Kirk P, Pavord S, Rajapakse R, Weston P, Wiggins T, Hutchinson PE. Value of a second freeze-thaw cycle in cryotherapy of common warts. Br J Dermatol. 1994 Dec;131(6):883-6. doi: 10.1111/j.1365-2133.1994.tb08594.x.

    PMID: 7857844BACKGROUND

  • Guidelines of care for cryosurgery. American Academy of Dermatology Committee on Guidelines of Care. J Am Acad Dermatol. 1994 Oct;31(4):648-53. No abstract available.

    PMID: 8089292BACKGROUND

  • Moed L, Shwayder TA, Chang MW. Cantharidin revisited: a blistering defense of an ancient medicine. Arch Dermatol. 2001 Oct;137(10):1357-60. doi: 10.1001/archderm.137.10.1357.

    PMID: 11594862BACKGROUND

MeSH Terms

Conditions

Warts

Interventions

Cantharidin

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Richard A Flygare, PhD

    TUI University; North Idaho Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 11, 2010

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

September 1, 2008

Last Updated

March 11, 2010

Record last verified: 2010-03

Locations

US(1)