A Trial Examining the Treatment of Common Warts With Combination Liquid Nitrogen (LN2) and Cantharidin - Full Text View

Purpose

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).

Condition	Intervention
Verruca Vulgaris	Drug: Liquid nitrogen and cantharidin Drug: Liquid nitrogen and topical placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized Clinical Trial Examining the Efficacy of Treatment of Cutaneous Verruca Vulgaris in Adult Patients With Combined Liquid Nitrogen Cryotherapy and Topically Applied Cantharidin

Resource links provided by NLM:

MedlinePlus related topics: Warts

U.S. FDA Resources

Further study details as provided by North Idaho Dermatology:

Primary Outcome Measures:

Percentage of common warts cleared [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percentage of treated warts cleared with treatment, as measured with dermatoscopic examination, after 12 weeks.

Enrollment:	70
Study Start Date:	June 2007
Study Completion Date:	September 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Liquid nitrogen and canthardin Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterwards.	Drug: Liquid nitrogen and cantharidin Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterward.
Placebo Comparator: Liquid nitrogen and placebo Liquid nitrogen applied to wart(s) then placebo vehicle afterwards.	Drug: Liquid nitrogen and topical placebo Liquid nitrogen applied to wart(s), then placebo vehicle applied thereafter.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084824

Locations

United States, Idaho
North Idaho Dermatology
Coeur D'Alene, Idaho, United States, 83814

Sponsors and Collaborators

North Idaho Dermatology

Investigators

Principal Investigator:

Richard A Flygare, PhD

TUI University; North Idaho Dermatology

More Information

Publications:

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.

[No authors listed] 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.

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

Responsible Party:	Richard Flygare, Ph.D.; Stephen Craig, M.D., North Idaho Dermatology, TUI University
ClinicalTrials.gov Identifier:	NCT01084824 History of Changes
Other Study ID Numbers:	NID-001
Study First Received:	March 10, 2010
Last Updated:	March 10, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by North Idaho Dermatology:

Warts
Verruca vulgaris
Liquid Nitrogen
Cantharidin
combination treatment

Additional relevant MeSH terms:

Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms

Skin Diseases, Infectious
Skin Diseases
Cantharidin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013