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

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

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