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 : September 23, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Irmgard E Kronberger, MD, Medical University Innsbruck

Study Description

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 :	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

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

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

Contacts and Locations

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:	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

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