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Trial record 4 of 1433 for:    ADAM
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Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial (AdAM)

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ClinicalTrials.gov Identifier: NCT03289260
Recruitment Status : Not yet recruiting
First Posted : September 20, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Irmgard E Kronberger, MD, Medical University Innsbruck

Study Description
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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

Study Design
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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 : April 15, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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
More Information
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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: March 22, 2018
Last Verified: March 2018
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