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

Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions

NCT03289260•Medical University Innsbruck

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

November 15, 2021

Primary Completion Date

November 15, 2024

Completion Date

November 15, 2024

Last Updated

September 23, 2020

Enrollment

200

ESTIMATED participants

Conditions

Anogenital Human Papillomavirus InfectionCondyloma Anal

Interventions

Imiquimod 5% cream

DRUG

Placebo cream

DRUG

Fulguration

PROCEDURE

Contacts

Irmgard E Kronberger, MD

CONTACT

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

Sascha Czipin, MD

CONTACT

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