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

NCT02377999 | Completed Phase 2

• 1 other identifier: EXP-1167
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anogenital Warts

Outcome Measures

Primary Outcomes (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

Study Arms (1)

Treatment of genetial warts with Picato

EXPERIMENTAL

Drug: Picato

Interventions

Picato DRUG

Treatment of genetial warts with Picato

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• In both sexes: inguinal, perineal, and perianal areas
• In men: penis shaft, scrotum, glans penis and foreskin
• In women: on the vulva
• \. Subjects has a total wart areas of at least 10 mm2, but not more than 500 mm2
• \. Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment

You may not qualify if:

• \. 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
• \. Subject suffer from any of the following conditions:
• Known human immunodeficiency virus (HIV) infection
• An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment
• Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment
• Has a dermatological disease (e.g. psoriasis) or skin condition in the wart areas
• \. Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment
• \. Prior quadrivalent HPV vaccination

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Merete Hædersdal, Professor MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: March 4, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 24, 2025

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)