Status and phase
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Treatments
About
An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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
Exclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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