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

This study has been completed.
Sponsor:
Information provided by:
North Idaho Dermatology
ClinicalTrials.gov Identifier:
NCT01084824
First received: March 10, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  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:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 September 14, 2014