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

NCT03289260 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-09-23

No results posted yet for this study

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

Conditions

  • Anogenital Human Papillomavirus Infection
  • Condyloma Anal

Interventions

DRUG

Imiquimod 5% cream

Patients receive topical Imiquimod therapy for 12 weeks.

DRUG

Placebo cream

Patients receive topical Doritin therapy for 12 weeks

PROCEDURE

Fulguration

Surgical Excision and Fulguration of condyloma

Sponsors & Collaborators

  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Dietmar Öfner-Velano, MD · University Hospital for Visceral, Transplant and Thoracic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2024-11-15
Completion
2024-11-15

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03289260 on ClinicalTrials.gov