A Comparative Study of Occlusive Heat Patch in the Treatment of Warts
The goal of this study is to determine the safety and efficacy of the occlusive heat patch for the treatment of verrucae (warts).
|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|
- 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.
|Study Start Date:||December 2012|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Heat Patch||
Device: Occlusive Heat Patch
The heat patch will be applied for 2 hours every day for a period of 12 weeks.
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.
|Contact: Kristin DeFrancesco, BSfirstname.lastname@example.org|
|United States, Connecticut|
|Yale School of Medicine||Recruiting|
|New Haven, Connecticut, United States, 06519|
|Contact: Kristin DeFrancesco, BS 203-785-3852 email@example.com|
|Principal Investigator: Richard Antaya, MD|
|Principal Investigator:||Richard Antaya, MD||Yale School of Medicine|