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

Verruca Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084824
• Other study ID #: NID-001
• Status: Completed
• Phase: N/A
• First received: March 10, 2010
• Last updated: March 10, 2010
• Start date: June 2007
• Est. completion date: September 2008

Study information

• Verified date: March 2010
• Source: North Idaho Dermatology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. common warts on non-genital, non-facial skin

2. otherwise healthy

3. between 18-65 and able to give informed consent

4. capable of tolerating treatment

Exclusion Criteria:

1. Ill-health

2. Poor tolerance or sensitivity to treatments in study

3. <18 years old; >65 years old

4. verruca plana or condyloma acuminata

5. immunosuppression or immune dysfunction

6. significant peripheral vascular disease

7. significant sensitivity to cold

8. epidermodysplasia verruciformis

9. mosaiform warts or periungual warts

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Verruca Vulgaris
• Warts

Intervention

Drug:
• Liquid nitrogen and cantharidin
Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterward.
• Liquid nitrogen and topical placebo
Liquid nitrogen applied to wart(s), then placebo vehicle applied thereafter.

Locations

Country	Name	City	State
United States	North Idaho Dermatology	Coeur D'Alene	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
North Idaho Dermatology

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Guidelines of care for cryosurgery. American Academy of Dermatology Committee on Guidelines of Care. J Am Acad Dermatol. 1994 Oct;31(4):648-53. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of common warts cleared	Percentage of treated warts cleared with treatment, as measured with dermatoscopic examination, after 12 weeks.	12 weeks	No