Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Anogenital Warts

Treatments: Drug: Picato

Study type: Interventional

Funder types: Industry

Identifiers

NCT02377999

EXP-1167

Details and patient eligibility

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: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  2. In both sexes: inguinal, perineal, and perianal areas

  3. In men: penis shaft, scrotum, glans penis and foreskin

  4. 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:

  3. Known human immunodeficiency virus (HIV) infection

  4. An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment

  5. Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment

  6. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Treatment of genetial warts with Picato

Experimental group

Treatment:

Drug: Picato