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

NCT01746056 | Completed

• 1 other identifier: 1209010850
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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).

Conditions

Verruca (Warts)

Keywords

Warts; Verruca; Heat patch

Outcome Measures

Primary Outcomes (3)

• 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.

  12 weeks

• 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.

  24 weeks

• 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.

  24 weeks

Secondary Outcomes (10)

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

  12 weeks

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

  36 weeks

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

  12 weeks

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

  36 weeks

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

  12 weeks

Study Arms (2)

Heat Patch Continuous

ACTIVE COMPARATOR

applied 2 hrs daily for 12 weeks

Device: Occlusive Heat Patch

Heat Patch Noncontinuous

ACTIVE COMPARATOR

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

Device: Occlusive Heat Patch

Interventions

Occlusive Heat Patch DEVICE

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

Heat Patch Continuous; Heat Patch Noncontinuous

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Yale University: lead
• Ferndale Laboratories, Inc.: collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• 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.

  PMID: 31012566 RESULT

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Richard Antaya, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: December 1, 2012
• Primary Completion: October 11, 2019
• Study Completion: October 31, 2019
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

US (1)