A Comparative Study of Occlusive Heat Patch in the Treatment of Warts
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ClinicalTrials.gov Identifier: NCT01746056 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 10, 2012
Last Update Posted
: March 15, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Verruca (Warts) | Device: Occlusive Heat Patch | Not Applicable |
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 |

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.
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- 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.

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Ages Eligible for Study: | 5 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746056
United States, Connecticut | |
Yale School of Medicine | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Richard Antaya, MD | Yale School of Medicine |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01746056 History of Changes |
Other Study ID Numbers: |
1209010850 |
First Posted: | December 10, 2012 Key Record Dates |
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 |