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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Verruca (Warts)	Device: Occlusive Heat Patch	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	31 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Comparative Study of Occlusive Heat Patch Vs. No Treatment in the Treatment of Verruca
Study Start Date :	December 2012
Actual Primary Completion Date :	December 2017
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Heat Patch	Device: Occlusive Heat Patch; The heat patch will be applied for 2 hours every day for a period of 12 weeks.

Outcome Measures

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Primary Outcome Measures :

1. Percent reduction in verrucae diameter [ Time Frame: 12 weeks ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	5 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

Ferndale Laboratories, Inc.

Investigators

Principal Investigator:	Richard Antaya, MD	Yale School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT01746056 History of Changes
Other Study ID Numbers:	1209010850
First Posted:	December 10, 2012
Last Update Posted:	March 15, 2018
Last Verified:	March 2018

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No
Product Manufactured in and Exported from the U.S.:		Yes

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; Skin Diseases, Infectious; Skin Diseases