Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment

A total of 42 subjects received standardized cryotherapy to all lesions, using two cycles of
five seconds each, separated by a five second interval rest (Week 0/Baseline). One week
following cryotherapy, subjects were randomized 1:1 to either additional treatment with
sinecatechins 15% ointment twice daily or no additional treatment. Those subjects randomized
to additional treatment received sinecatechins 15% ointment BID for up to sixteen weeks, or
until complete clearance of all EGW, whichever occurred first. Additionally, subjects were
advised to maintain safe sexual practices and have all recent sexual partners examined for
EGW. Subjects were followed every 8 weeks for a total of 16 weeks (Table 1). EGW lesion
counts were conducted at all study visits by the same qualified blinded evaluator.
Additionally, at each visit local skin reactions, change in concomitant medications, and
adverse events were assessed. Any subjects who received sinecatechins 15% ointment and
discontinued prematurely were asked to return for an End of Study Visit. Females of
childbearing potential underwent a urine pregnant test at all visits during study treatment
period. Subjects that met complete responder criteria as above, were additionally followed
and assessed at Visit5/Week 41 and Visit 6/Week 65 to assess for wart recurrence.

Inclusion Criteria:

- Adults at least 18 years old with at least two visible EGWs.

- Subject must be in good general health as confirmed by the medical history.

- Subject must be able to read, sign, and understand the informed consent.

- Subject must be willing to forego any other treatments for his/her EGW lesions.

- Subject is willing and able to participate in the study as an outpatient, making
frequent visits to the study center during the treatment and follow-up periods and to
comply with all study requirements including concomitant medication and other
treatment restrictions.

- If subject is a female of childbearing potential she must have a negative urine
pregnancy test result prior to study treatment initiation and must agree to use an
approved method of birth control while enrolled in the study.

Exclusion Criteria:

- Subject with any evidence of herpes genitalis or any other current and/or recurrent
genital or uncontrolled infection, including Human Immunodeficiency Virus, Hepatitis B
or Hepatitis C.

- Subject with an unstable medical condition as deemed by the clinical investigator.

- Subject with any dermatologic disease in the treatment area that may be exacerbated by
the treatment proposed or that might impair the evaluation of EGW lesions.

- Subject who has previously been treated in an EGW clinical trial, had treatment of
anogenital warts or had systemic intake of virostatics or immunosuppressive medication
within 30 days prior to Baseline Visit.

- Women who are pregnant, lactating, or planning to become pregnant during the study
period.

- Subject who have experienced a clinically important medical event within 90 days of
the visit (e.g., stroke, myocardial infarction, etc).

- Subject who have active chemical dependency or alcoholism as assessed by the
investigator.

- Subject who have known allergies to any component of the study ointment.

- Subject who have organ allograft, skin conditions that may interfere with study
ointment, or having internal (vaginal or rectal) warts that have required treatment.

- Subject who has received any of the following within 90 days prior to study treatment
initiation:

- interferon or interferon inducers

- cytotoxic drugs

- immunomodulators or immunosuppressive therapies (inhaled/ intranasal
corticosteroids are permitted)

- oral or parenteral corticosteroids

- topical corticosteroids if greater than 2 gm/day

- any dermatologic procedures or surgeries on the study area (including any EGW
treatments)

- Subject who have used any topical prescription medications on the study area within 30
days prior to study treatment initiation.