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

Anogenital Warts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377999
• Other study ID #: EXP-1167
• Status: Completed
• Phase: Phase 2
• First received: February 20, 2015
• Last updated: May 1, 2017
• Start date: February 2015
• Est. completion date: November 2015

Study information

• Verified date: May 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anogenital Warts
• Condylomata Acuminata
• Warts

Intervention

Drug:
• Picato

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incidence and severity of Local Skin Reactions (LSR)		Measured two weeks after every treatment and final measurement 2 weeks after last treatment

External Links

•   Clinical Trials at LEO Pharma