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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |

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 |
- Difference in recurrence rates between the two arms [ Time Frame: 12 months ]Recurrence is evaluated by clinical examination (proctoscopy)
- CD4 (cluster of differentiation 4) cell count [ Time Frame: 12 months ]Influence of CD4 cell count in the subgroup of HIV positive patients

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Austria | |
Visceral-, Transplant- and Thoracic Surgery | |
Innsbruck, Tyrol, Austria, 6020 |
Study Director: | Dietmar Öfner-Velano, MD | University Hospital for Visceral, Transplant and Thoracic Surgery |
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 |
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 |
Condylomata acuminata, Fulguration, Imiquimod |
Papillomavirus Infections DNA Virus Infections Virus Diseases Infections Tumor Virus Infections Imiquimod |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Interferon Inducers |