UnknownPhase 3

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

Austria200 participantsStarted 2021-11-15

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Difference in recurrence rates between the two arms

Timeframe: 12 months

Trial details

NCT IDNCT03289260

SponsorMedical University Innsbruck

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-15

Contact for this trial

Irmgard E Kronberger, MD

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

View on ClinicalTrials.gov More Anogenital Human Papillomavirus Infection trials