A Comparative Study of Occlusive Heat Patch in the Treatment of Warts (NCT01746056) | Clinical Trial Compass
CompletedNot Applicable
A Comparative Study of Occlusive Heat Patch in the Treatment of Warts
United States73 participantsStarted 2012-12
Plain-language summary
The goal of this study is to determine the safety and efficacy of the occlusive heat patch for the treatment of verrucae (warts).
Who can participate
Age range5 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
Exclusion Criteria:
Proof of Concept Study:
* Subjects who are immunocompromised for any reason or are known to be HIV+ based on me…
What they're measuring
1
Percent reduction in verrucae diameter - proof of concept study
Timeframe: 12 weeks
2
Count of participants with an IGS score = 0 on target verruca - confirmation study
Timeframe: 24 weeks
3
Count of participants with an IGS score = 0 on at least 1 non-target verruca - confirmation study