Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01746056
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2012-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Study of Occlusive Heat Patch in the Treatment of Warts
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
A Comparative Study of Occlusive Heat Patch Vs. No Treatment in the Treatment of Verruca
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
The changes to the title, endpoints, inclusion and exclusion criteria were revised to reflect the second, final phase of this trial. The first portion of the trial, a proof of concept trial, was completed and the results published in an article added to the citations section.
A significant delay occurred in completion of this second phase of the trial due to personnel issues and interruptions secondary to COVID-19 pandemic restrictions.
The changes to the title, endpoints, inclusion and exclusion criteria were revised to reflect the second, final phase of this trial. The first portion of the trial, a proof of concept trial, was completed and the results published in an article added to the citations section.
A significant delay occurred in completion of this second phase of the trial due to personnel issues and interruptions secondary to COVID-19 pandemic restrictions.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: