Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts
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An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals.
Condition or disease
The purpose of the present trial is to explore the safety, tolerability and efficacy when treating GW with Picato® 0.05% gel. The primary outcome measures will be related to safety and tolerability and consists of severity of any local reactions in the treated area; treatment-related adverse events (AEs) and serious AEs.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
1. A clinical diagnosis of external anogenital/perianal warts with at least 2 warts and no more than 20 warts located in one or more of the following anatomic locations:
In both sexes: inguinal, perineal, and perianal areas
In men: penis shaft, scrotum, glans penis and foreskin
In women: on the vulva
2. Subjects has a total wart areas of at least 10 mm2, but not more than 500 mm2
3. Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment
1. Subject has received any topical and/or destructive treatments for external anogenital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrolment
2. Subject suffer from any of the following conditions:
Known human immunodeficiency virus (HIV) infection
An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment
Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment
Has a dermatological disease (e.g. psoriasis) or skin condition in the wart areas
3. Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment