Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial
NCT ID: NCT03289260
Last Updated: 2020-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2021-11-15
2024-11-15
Brief Summary
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Aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical Imiquimod-therapy). It is planned to include 200 patients.
100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive surgical therapy + topical Placebo therapy
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Interventional Arm
Imiquimod 5% cream therapy Fulguration
Imiquimod 5% cream
Patients receive topical Imiquimod therapy for 12 weeks.
Fulguration
Surgical Excision and Fulguration of condyloma
Placebo Arm
Placebo cream therapy Fulguration
Placebo cream
Patients receive topical Doritin therapy for 12 weeks
Fulguration
Surgical Excision and Fulguration of condyloma
Interventions
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Imiquimod 5% cream
Patients receive topical Imiquimod therapy for 12 weeks.
Placebo cream
Patients receive topical Doritin therapy for 12 weeks
Fulguration
Surgical Excision and Fulguration of condyloma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female patients \>= 18 years of age
* Negative urine/serum pregnancy test
* Indication for surgical therapy of anal HPV lesions
Exclusion Criteria
* Diagnosis and therapy of HPV associated lesions in the last 12 months
* Known intolerance of hypersensitivity to Imiquimod
* Women who are pregnant of lactating
18 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Irmgard E Kronberger, MD
Leading Consultent
Principal Investigators
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Dietmar Öfner-Velano, MD
Role: STUDY_DIRECTOR
University Hospital for Visceral, Transplant and Thoracic Surgery
Locations
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Visceral-, Transplant- and Thoracic Surgery
Innsbruck, Tyrol, Austria
Countries
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Central Contacts
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Other Identifiers
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AdAM_2017
Identifier Type: -
Identifier Source: org_study_id
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