Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Difference in recurrence rates between the two arms
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Interventional Arm
Imiquimod 5% cream therapy Fulguration
Intervention: Imiquimod 5% cream (Drug)
Interventional Arm
Imiquimod 5% cream therapy Fulguration
Intervention: Fulguration (Procedure)
Placebo Arm
Placebo cream therapy Fulguration
Intervention: Placebo cream (Drug)
Placebo Arm
Placebo cream therapy Fulguration
Intervention: Fulguration (Procedure)
Outcomes
Primary Outcomes
Difference in recurrence rates between the two arms
Time Frame: 12 months
Recurrence is evaluated by clinical examination (proctoscopy)
Secondary Outcomes
- CD4 (cluster of differentiation 4) cell count(12 months)
Investigators
Irmgard E Kronberger, MD
Leading Consultent
Medical University Innsbruck