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

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.

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