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

• Status: Not yet recruiting
• Trial end date: 2024-11-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University Innsbruck
• Treatments: Imiquimod

Criteria

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