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Verruca (Warts)NCT01746056

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

A study testing Occlusive Heat Patch in people with Verruca (Warts), run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 5 years and older
Conditions the study is for
Verruca (Warts)
What is being tested?
Occlusive Heat Patch
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
Dec 2012to 31 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Proof of Concept Study:
  • 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.
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  • Confirmation Study:
  • Male or female 5 -25 years of age at the baseline visit.
  • Written consent (adults) and written assent (minors).
  • Subjects with one clinically diagnosed verruca, 2-20 mm in largest diameter.
  • Subjects must be willing and able to apply the study patch as directed, comply with study instructions and return for required visits.

Who cannot join

  • Proof of Concept Study:
  • 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.
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  • 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
  • Confirmation Study:
  • 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 within 4 weeks of enrollment; cimetidine, systemic steroids, immunomodulators or immunosuppressants.
  • Subjects who have used any destructive anti-verruca treatments within 4 weeks. These include but are not limited to cryotherapy, topical salicylic acid preparations, podophyllin-containing preparations, intralesional bleomycin, or surgical procedures. No immunotherapy (topical allergens or intralesional antigen injections) or topical sinecatechins ointment, imiquimod cream 6 months before baseline visit.
  • 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 verrucae only located in the genital or head regions or possessing only mosaic, flat or filiform warts.
  • Subjects with verrucae only located in areas 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 of the patches (including the liquid adhesive and adhesive remover).
  • 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.
  • During the study, concomitant use of the following medications or treatments is PROHIBITED:
  • Systemic corticosteroids, immunosuppressants, immunomodulators, cimetidine. Topical treatments to the area containing the target verruca intended to treat warts including, podophyllin, salicylic acid preparations, intralesional bleomycin, surgical procedures or immunotherapy (topical allergens or intralesional antigen injections) or topical sinecatechins ointment and imiquimod cream among others.
  • Medications or treatments that might interfere with the evaluation of the occlusive patch should not be used.
  • Changes in general skin care treatment during the study should also be discouraged.
  • There will be no use of medication which, in the opinion of the investigators, will interfere with the study results.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale School of Medicine

    New Haven, Connecticut, 06519

Other trials in United States

About this study

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

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

Read the 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.

Conditions
Verruca (Warts)
Being tested
Occlusive Heat Patch
Keywords
Warts, Verruca, Heat patch
Medical subject headings
Warts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Occlusive Heat PatchDevice

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

Study groups in NCT01746056
Study groupRoleWhat they receive
Heat Patch ContinuousActive comparatorapplied 2 hrs daily for 12 weeks
Receives: Device: Occlusive Heat Patch
Heat Patch NoncontinuousActive comparatorapplied 2 hrs daily 2 weeks on and 2 weeks off for 12 weeks
Receives: Device: Occlusive Heat Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent reduction in verrucae diameter - proof of concept study

    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.

    Measured: 12 weeks

  2. Count of participants with an IGS score = 0 on target verruca - confirmation study

    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.

    Measured: 24 weeks

  3. Count of participants with an IGS score = 0 on at least 1 non-target verruca - confirmation study

    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.

    Measured: 24 weeks

Secondary outcomes (10)

  1. Count of participants with an IGS score = 0 on target verruca - confirmation study

    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.

    Measured: 12 weeks

  2. Count of participants with an IGS score = 0 on target verruca - confirmation study

    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.

    Measured: 36 weeks

  3. Count of participants with an IGS score = 0 on at least 1 non-target verruca - confirmation study

    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.

    Measured: 12 weeks

  4. Count of participants with an IGS score = 0 on at least 1 non-target verruca - confirmation study

    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.

    Measured: 36 weeks

  5. Count of participants with an IGS score < = 2 on target verruca - confirmation study

    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.

    Measured: 12 weeks

  6. Count of participants with an IGS score < = 2 on target verruca - confirmation study

    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.

    Measured: 24 weeks

  7. Count of participants with an IGS score < = 2 on target verruca - confirmation study

    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.

    Measured: 36 weeks

  8. Count of participants with an IGS score < = 2 on at least 1 non-target verruca - confirmation study

    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.

    Measured: 12 weeks

  9. Count of participants with an IGS score < = 2 on at least 1 non-target verruca - confirmation study

    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.

    Measured: 24 weeks

  10. Count of participants with an IGS score < = 2 on at least 1 non-target verruca - confirmation study

    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.

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completion11 Oct 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
one arm receiving intervention in daily for 12 week the other receives the intervention 2 weeks on and 2 weeks off for 12 weeks
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01746056
Sponsor's protocol ID
1209010850
Status last verified
Nov 2022
First submitted
6 Dec 2012
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Antaya RJ, del Carmen M, Alonso F, Sukumar N, Yong F, Dvoretzky I. An Open Label Study of an Occlusive Heat Patch in the Treatment of Warts. J Drugs Dermatol. 2019 Apr 1;18(4):368-373.

    PubMed 31012566

Questions about this trial

What is this clinical trial studying?

A study testing Occlusive Heat Patch in people with Verruca (Warts), run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent reduction in verrucae diameter - proof of concept study (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01746056, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.

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