Back to resultsAdjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial (AdAM)
Primary Purpose
Anogenital Human Papillomavirus Infection, Condyloma Anal
Status
Not yet recruiting
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Imiquimod 5% cream
Placebo cream
Fulguration
Sponsored by
About this trial
This is an interventional treatment trial for Anogenital Human Papillomavirus Infection focused on measuring Condylomata acuminata, Fulguration, Imiquimod
Eligibility 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
Sites / Locations
- Visceral-, Transplant- and Thoracic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Interventional Arm
Placebo Arm
Arm Description
Imiquimod 5% cream therapy Fulguration
Placebo cream therapy Fulguration
Outcomes
Primary Outcome Measures
Difference in recurrence rates between the two arms
Recurrence is evaluated by clinical examination (proctoscopy)
Secondary Outcome Measures
CD4 (cluster of differentiation 4) cell count
Influence of CD4 cell count in the subgroup of HIV positive patients
Full Information
NCT ID
NCT03289260
First Posted
September 19, 2017
Last Updated
September 22, 2020
Sponsor
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT03289260
Brief Title
Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial
Acronym
AdAM
Official Title
Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2021 (Anticipated)
Primary Completion Date
November 15, 2024 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University Innsbruck
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anogenital Human Papillomavirus Infection, Condyloma Anal
Keywords
Condylomata acuminata, Fulguration, Imiquimod
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional Arm
Arm Type
Experimental
Arm Description
Imiquimod 5% cream therapy Fulguration
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Placebo cream therapy Fulguration
Intervention Type
Drug
Intervention Name(s)
Imiquimod 5% cream
Other Intervention Name(s)
Aldara
Intervention Description
Patients receive topical Imiquimod therapy for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo cream
Other Intervention Name(s)
Doritin
Intervention Description
Patients receive topical Doritin therapy for 12 weeks
Intervention Type
Procedure
Intervention Name(s)
Fulguration
Intervention Description
Surgical Excision and Fulguration of condyloma
Primary Outcome Measure Information:
Title
Difference in recurrence rates between the two arms
Description
Recurrence is evaluated by clinical examination (proctoscopy)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
CD4 (cluster of differentiation 4) cell count
Description
Influence of CD4 cell count in the subgroup of HIV positive patients
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irmgard E Kronberger, MD
Phone
0043512504
Ext
80823
Email
irmgard.kronberger@i-med.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Sascha Czipin, MD
Phone
0043512504
Ext
82070
Email
sascha.czipin@i-med.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dietmar Öfner-Velano, MD
Organizational Affiliation
University Hospital for Visceral, Transplant and Thoracic Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Visceral-, Transplant- and Thoracic Surgery
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial
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