A Comparative Study of Occlusive Heat Patch in the Treatment of Warts

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Collaborator:
Ferndale Laboratories, Inc.
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01746056
First received: December 6, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

The goal of this study is to determine the safety and efficacy of the occlusive heat patch for the treatment of verrucae (warts).


Condition Intervention
Verruca (Warts)
Device: Occlusive Heat Patch

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Study of Occlusive Heat Patch Vs. No Treatment in the Treatment of Verruca

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Percent reduction in verrucae diameter [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Efficacy will be determined by the percent reduction in verruca diameter (Lesion Measurement). A severity grade will be given to the target and control warts using the Investigator Global Improvement Score (IGIS). IGIS scale scores are as follows: 4 = Same or worse, 3 = Minimal Improvement, 2 = Marked Improvement, 1 = Almost Clear, 0 = Clear.


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heat Patch Device: Occlusive Heat Patch
The heat patch will be applied for 2 hours every day for a period of 12 weeks.

Detailed Description:

Human papillomavirus (HPV) is a virus that causes verrucae, or warts, on the skin, particularly of the distal extremities, and lesions of the mucous membranes. Warts are highly prevalent, occurring in up to 13% of the general population and in around 25% of otherwise healthy children. About 67% of warts resolve spontaneously within two years; however more than 25% will persist for many years, some resulting in pain or dysfunction and some imparting significant psychosocial problems. Localized hyperthermia (warming) has been reported to be effective in the treatment of HPV-induced warts for nearly two decades. A novel method of treating warts with heat is the use of an occlusive patch that contains a mixture of chemicals (ferric chloride), which in the presence of oxygen reacts to generate reproducible thermal warming of the skin to a temperature of 42-43ºC for at least two hours. The heat is believed to alter the immune response and kill the HPV virus in the wart tissue.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant female 5 years of age or older.
  • Written consent (adults) and written assent (minors).
  • Subjects with a minimum of two clinically diagnosed verrucae 4 cm in diameter or less in a similar treatment area.
  • Subjects must be willing and able to apply the occlusive heat patch(s) as directed, comply with study instructions and return to the clinic for required visits.
  • Women of childbearing potential (WOCBP) must agree to use an effective form of birth control for the duration of the study (abstinence, stabilized on oral contraceptives or contraceptive patches for at least three months, implant, injection, intrauterine device, NuvaRing®, condom and spermicidal or diaphragm and spermicidal). Abstinence is an acceptable form of birth control for subjects who are not sexually active. Subjects that become sexually active during the trial must agree to use an effective, non-prohibited form of birth control for the duration of the study.

Exclusion Criteria:

  • Subjects who are immunocompromised for any reason or are known to be HIV+ based on medical history taken at screening.
  • Subjects taking any of the following systemic therapy with 4 weeks of enrollment; cimetidine, systemic steroids, immunomodulators or immunosuppressants.
  • Subjects who have used any anti-verruca treatments within 4 weeks. These include but are not limited to topical salicylic acid preparations, imiquimod (Aldara), podophyllin containing preparations, surgical procedures, immunotherapy, among others.
  • Subjects who have active localized or systemic medical conditions that in the opinion of the investigator, would preclude their participation in the study or interfere with their assessment of their verrucae.
  • Subjects with any underlying disease(s) or a dermatological condition of the affected area(s) that requires the use of interfering topical or systemic therapy.
  • Subjects with verruca, for treatment, that are located in the periungual, genital, or head regions or have mosaic warts.
  • Subjects with verruca, for treatment, that is associated with significant scarring from prior therapy in the opinion of the investigator.
  • Subjects who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
  • Subjects with any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in a research study.
  • Subjects with a history of allergy or sensitivity to any of the components or the patches (including the adhesives).
  • Subjects who are currently enrolled in a clinical drug or device research study.
  • Subjects who have been treated with another investigational device or drug within 30 days prior to study enrollment.
  • Subject is pregnant, nursing or planning a pregnancy during the study period
  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: NCT01746056

Contacts
Contact: Kristin DeFrancesco, BS 203-785-3852 kristin.defrancesco@yale.edu

Locations
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Contact: Kristin DeFrancesco, BS    203-785-3852    kristin.defrancesco@yale.edu   
Principal Investigator: Richard Antaya, MD         
Sponsors and Collaborators
Yale University
Ferndale Laboratories, Inc.
Investigators
Principal Investigator: Richard Antaya, MD Yale School of Medicine
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01746056     History of Changes
Other Study ID Numbers: 1209010850
Study First Received: December 6, 2012
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Warts
Verruca
Heat patch

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014