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

Phase 3

Not yet recruiting

• Conditions: Anogenital Human Papillomavirus Infection; Condyloma Anal
• Interventions: Drug: Imiquimod 5% cream; Drug: Placebo cream; Procedure: Fulguration

• Registration Number: NCT03289260
• Lead Sponsor: Medical University Innsbruck

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-23
• Study Start: 2021-11-15
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Arm	Imiquimod 5% cream	Imiquimod 5% cream therapy Fulguration
Interventional Arm	Fulguration	Imiquimod 5% cream therapy Fulguration
Placebo Arm	Placebo cream	Placebo cream therapy Fulguration
Placebo Arm	Fulguration	Placebo cream therapy Fulguration

Primary Outcome Measures

Name	Time	Method
Difference in recurrence rates between the two arms	12 months	Recurrence is evaluated by clinical examination (proctoscopy)

Secondary Outcome Measures

Name	Time	Method
CD4 (cluster of differentiation 4) cell count	12 months	Influence of CD4 cell count in the subgroup of HIV positive patients

Trial Locations

Locations (1)

Visceral-, Transplant- and Thoracic Surgery; 🇦🇹 Innsbruck, Tyrol, Austria