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

September 22, 2020 updated by: Irmgard E Kronberger, MD, Medical University Innsbruck

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Visceral-, Transplant- and Thoracic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Interventional Arm
Imiquimod 5% cream therapy Fulguration
Drug: Imiquimod 5% cream
Patients receive topical Imiquimod therapy for 12 weeks.
Other Names:
  • Aldara
Procedure: Fulguration
Surgical Excision and Fulguration of condyloma
PLACEBO_COMPARATOR: Placebo Arm
Placebo cream therapy Fulguration
Procedure: Fulguration
Surgical Excision and Fulguration of condyloma
Drug: Placebo cream
Patients receive topical Doritin therapy for 12 weeks
Other Names:
  • Doritin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in recurrence rates between the two arms
Time Frame: 12 months
Recurrence is evaluated by clinical examination (proctoscopy)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD4 (cluster of differentiation 4) cell count
Time Frame: 12 months
Influence of CD4 cell count in the subgroup of HIV positive patients
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Study Director: Dietmar Öfner-Velano, MD, University Hospital for Visceral, Transplant and Thoracic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 15, 2021

Primary Completion (ANTICIPATED)

November 15, 2024

Study Completion (ANTICIPATED)

November 15, 2024

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (ACTUAL)

September 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AdAM_2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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