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

• Sponsor: LEO Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02377999
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 9
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anogenital Warts	Drug: Picato	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment of genetial warts with Picato	Drug: Picato

Outcome Measures

Primary Outcome Measures

1. Number of incidence and severity of Local Skin Reactions (LSR) [Measured two weeks after every treatment and final measurement 2 weeks after last treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

• 1. Subjects has a total wart areas of at least 10 mm2, but not more than 500 mm2
• 1. 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
• 1. 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

• 1. Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment
• 1. Prior quadrivalent HPV vaccination

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bispebjerg Hospital	Copenhagen NV		Denmark	2400

Sponsors and Collaborators

• LEO Pharma

Investigators

• Principal Investigator: Merete Hædersdal, Professor MD, Bispebjerg Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT02377999
• Other Study ID Numbers: EXP-1167
• First Posted: Mar 4, 2015
• Last Update Posted: May 3, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Warts; Condylomata Acuminata

Study Results

No Results Posted as of May 3, 2017