Anogenital warts MedDRA version: 17.1 Level: PT Classification code 10059313 Term: Anogenital warts System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Picato®
Product Name: Picato®
Pharmaceutical Form: Gel
INN or Proposed INN: Ingenol Mebutate
CAS Number: 75567-37-2
Other descriptive name: 3-Angeloyl ingenol, Ingenol-3-angelate, 3-O-ange
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or Female of 18 years or above - Has a clinical diagnosis of external genital/perianal warts with at least 2 warts and no more than 20 warts located in one or more of the following anatomic locations: a. In both sexes: perineal, and perianal areas b. In men: penis shaft, scrotum, glans penis and foreskin c. In women: on the vulva - Subjects have a total wart areas of at least 10 mm2, but no more than 500 mm2 - Female subjects of childbearing potential must be confirmed not pregnant Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subject has received any topical and/or destructive treatments for external genital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrolment - Subject suffer from any of the following conditions: a. Known human immunodeficiency virus (HIV) infection b. An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment c. Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment d. Has a dermatological disease (e.g. psoriasis) or skin condition in the wart areas - Subjects that are organ transplant recipients - Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of single treatment with Picato® 0.05% repeated up to 2 times with two weeks intervals in subjects with anogenital warts.;Secondary Objective: To evaluate the efficacy of a single treatment with Picato® 0.05% repeated up to 2 times with two weeks intervals in subjects with anogenital warts. To evaluate the recurrence rate of anogenital warts after 12 weeks in subjects who were completely clear of anogenital warts during the treatment. ;Primary end point(s): Incidence and severity of Local Skin Reactions (LSR) and treatment related adverse events;Timepoint(s) of evaluation of this end point: From first treatment and until start of Follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence and severity of Adverse Events Complete clearance of the anogenital warts after end of trial and by visits Reduction in anogenital warts count from baseline to end of trial and by visits Recurrence rate ;Timepoint(s) of evaluation of this end point: From first treatment and until Follow up completed | — |
Countries
Denmark
Contacts
Public ContactGlobal Clinical Operations
LEO Pharma A/S
Outcome results
None listed