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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03289260
Recruitment Status : Not yet recruiting
First Posted : September 20, 2017
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Irmgard E Kronberger, MD, 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


Condition or disease Intervention/treatment Phase
Anogenital Human Papillomavirus Infection Condyloma Anal Drug: Imiquimod 5% cream Drug: Placebo cream Procedure: Fulguration Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions
Estimated Study Start Date : November 15, 2021
Estimated Primary Completion Date : November 15, 2024
Estimated Study Completion Date : November 15, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: Interventional Arm
Imiquimod 5% cream therapy Fulguration
Drug: Imiquimod 5% cream
Patients receive topical Imiquimod therapy for 12 weeks.
Other Name: Aldara

Procedure: Fulguration
Surgical Excision and Fulguration of condyloma

Placebo Comparator: Placebo Arm
Placebo cream therapy Fulguration
Drug: Placebo cream
Patients receive topical Doritin therapy for 12 weeks
Other Name: Doritin

Procedure: Fulguration
Surgical Excision and Fulguration of condyloma




Primary Outcome Measures :
  1. Difference in recurrence rates between the two arms [ Time Frame: 12 months ]
    Recurrence is evaluated by clinical examination (proctoscopy)


Secondary Outcome Measures :
  1. CD4 (cluster of differentiation 4) cell count [ Time Frame: 12 months ]
    Influence of CD4 cell count in the subgroup of HIV positive patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289260


Contacts
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Contact: Irmgard E Kronberger, MD 0043512504 ext 80823 irmgard.kronberger@i-med.ac.at
Contact: Sascha Czipin, MD 0043512504 ext 82070 sascha.czipin@i-med.ac.at

Locations
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Austria
Visceral-, Transplant- and Thoracic Surgery
Innsbruck, Tyrol, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Study Director: Dietmar Öfner-Velano, MD University Hospital for Visceral, Transplant and Thoracic Surgery
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Responsible Party: Irmgard E Kronberger, MD, Leading Consultent, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03289260    
Other Study ID Numbers: AdAM_2017
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Irmgard E Kronberger, MD, Medical University Innsbruck:
Condylomata acuminata, Fulguration, Imiquimod
Additional relevant MeSH terms:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers