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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377999
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377999


Locations
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Denmark
Bispebjerg Hospital
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Merete Hædersdal, Professor MD Bispebjerg Hospital
Additional Information:
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02377999    
Other Study ID Numbers: EXP-1167
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases