Anogenital Warts
Conditions
Brief summary
An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals.
Detailed 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.
Interventions
DRUGPicato
Sponsors
LEO Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: 1. In both sexes: inguinal, perineal, and perianal areas 2. In men: penis shaft, scrotum, glans penis and foreskin 3. 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
Exclusion criteria
* 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: 1. Known human immunodeficiency virus (HIV) infection 2. An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment 3. Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment 4. 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 * 4\. Prior quadrivalent HPV vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of incidence and severity of Local Skin Reactions (LSR) | Measured two weeks after every treatment and final measurement 2 weeks after last treatment |
Countries
Denmark
Outcome results
None listed