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

Anogenital Human Papillomavirus Infection Clinical Trial

— AdAM  

Official title:

Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03289260
• Other study ID #: AdAM_2017
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 15, 2021
• Est. completion date: November 15, 2024

Study information

• Verified date: September 2020
• Source: Medical University Innsbruck
• Contact: Irmgard E Kronberger, MD
• Phone: 0043512504
• Email: irmgard.kronberger[@]i-med.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anogenital Human Papillomavirus Infection
• Condyloma Anal
• Papillomavirus Infections

Intervention

Drug:
• Imiquimod 5% cream
Patients receive topical Imiquimod therapy for 12 weeks.
• Placebo cream
Patients receive topical Doritin therapy for 12 weeks

Procedure:
• Fulguration
Surgical Excision and Fulguration of condyloma

Locations

Country	Name	City	State
Austria	Visceral-, Transplant- and Thoracic Surgery	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in recurrence rates between the two arms	Recurrence is evaluated by clinical examination (proctoscopy)	12 months
Secondary	CD4 (cluster of differentiation 4) cell count	Influence of CD4 cell count in the subgroup of HIV positive patients	12 months