Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial

Medical University Innsbruck200 enrolled

Overview

AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients receiving surgical therapy due to anal HPV infection. 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Anogenital Human Papillomavirus Infection Condyloma Anal

Interventions

Imiquimod 5% creamDRUG

Patients receive topical Imiquimod therapy for 12 weeks.

Placebo creamDRUG

Patients receive topical Doritin therapy for 12 weeks

FulgurationPROCEDURE

Surgical Excision and Fulguration of condyloma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ability to understand and willingness to sign and date a written consent document * Male and female patients \>= 18 years of age * Negative urine/serum pregnancy test * Indication for surgical therapy of anal HPV lesions Exclusion Criteria: * Participation in another clinical study with experimental therapy * Diagnosis and therapy of HPV associated lesions in the last 12 months * Known intolerance of hypersensitivity to Imiquimod * Women who are pregnant of lactating

Locations (1)

Visceral-, Transplant- and Thoracic Surgery

Innsbruck, Tyrol, Austria

Outcomes

Primary Outcomes

Difference in recurrence rates between the two arms

Recurrence is evaluated by clinical examination (proctoscopy)

Time frame: 12 months

Secondary Outcomes

CD4 (cluster of differentiation 4) cell count

Influence of CD4 cell count in the subgroup of HIV positive patients

Time frame: 12 months

Central Contacts

Irmgard E Kronberger, MD

CONTACT

0043512504 irmgard.kronberger@i-med.ac.at

Sascha Czipin, MD

CONTACT

0043512504 sascha.czipin@i-med.ac.at

Data from ClinicalTrials.gov

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