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

NCT03289260 | Unknown Phase 3 DMC

• 1 other identifier: AdAM_2017
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Anogenital Human Papillomavirus Infection; Condyloma Anal

Keywords

Condylomata acuminata, Fulguration, Imiquimod

Outcome Measures

Primary Outcomes (1)

• Difference in recurrence rates between the two arms

  Recurrence is evaluated by clinical examination (proctoscopy)

  12 months

Secondary Outcomes (1)

• CD4 (cluster of differentiation 4) cell count

  12 months

Study Arms (2)

Interventional Arm

EXPERIMENTAL

Imiquimod 5% cream therapy Fulguration

Drug: Imiquimod 5% cream; Procedure: Fulguration

Placebo Arm

PLACEBO COMPARATOR

Placebo cream therapy Fulguration

Drug: Placebo cream; Procedure: Fulguration

Interventions

Imiquimod 5% cream DRUG

Patients receive topical Imiquimod therapy for 12 weeks.

Also known as: Aldara

Interventional Arm

Placebo cream DRUG

Patients receive topical Doritin therapy for 12 weeks

Also known as: Doritin

Placebo Arm

Fulguration PROCEDURE

Surgical Excision and Fulguration of condyloma

Interventional Arm; Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Visceral-, Transplant- and Thoracic Surgery

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Imiquimod; Diathermy

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hyperthermia, Induced; Therapeutics

Study Officials

• Dietmar Öfner-Velano, MD

  University Hospital for Visceral, Transplant and Thoracic Surgery

  STUDY DIRECTOR

Central Study Contacts

Irmgard E Kronberger, MD

CONTACT

0043512504; irmgard.kronberger@i-med.ac.at

Sascha Czipin, MD

CONTACT

0043512504; sascha.czipin@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leading Consultent

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 20, 2017
• Study Start: November 15, 2021
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

AU (1)