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Skin Diseases, Infectious

applied 2 hrs daily 2 weeks on and 2 weeks off for 12 weeks

The heat patch will be applied for 2 hours every day for a period of 12 weeks.

Occlusive Heat Patch

Richard Antaya, MD

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

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.

one arm receiving intervention in daily for 12 week the other receives the intervention 2 weeks on and 2 weeks off for 12 weeks

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

A Comparative Study of Occlusive Heat Patch Vs. No Treatment in the Treatment of Verruca

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.

To assess the efficacy of the heat patch in the confirmation study, the count of subjects (in each arm and combined) achieving an IGIS of 0 (complete clearance) of the target verruca will be assessed. Investigator Global Improvement Score (IGIS) scale scores are as follows: 4 = Same or worse, 3 = Minimal Improvement, 2 = Marked Improvement, 1 = Almost Clear, 0 = Clear.

To assess the efficacy of the heat patch in the confirmation study, the count of subjects greater than one verruca that demonstrate clearance of one or more than one non-target verruca will be assessed. Investigator Global Improvement Score (IGIS) scale scores are as follows: 4 = Same or worse, 3 = Minimal Improvement, 2 = Marked Improvement, 1 = Almost Clear, 0 = Clear.

To assess the efficacy of the heat patch in the confirmation study, the count of subjects (in each arm and combined) achieving an IGIS of \< = 2 of the target verruca will be assessed. Investigator Global Improvement Score (IGIS) scale scores are as follows: 4 = Same or worse, 3 = Minimal Improvement, 2 = Marked Improvement, 1 = Almost Clear, 0 = Clear.

To assess the efficacy of the heat patch in the confirmation study, the count of subjects greater than one verruca that demonstrate an IGS score \< = 2 on one or more non-target verruca will be assessed. Investigator Global Improvement Score (IGIS) scale scores are as follows: 4 = Same or worse, 3 = Minimal Improvement, 2 = Marked Improvement, 1 = Almost Clear, 0 = Clear.

Spots Global Cancer Trial Database for heat patch

Every month we try and update this database with for heat patch cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for heat patch

Every month we try and update this database with for heat patch cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for heat patch cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.