Anogenital Human Papillomavirus Infection, Condyloma Anal
Conditions
Keywords
Condylomata acuminata, Fulguration, Imiquimod
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
Interventions
Patients receive topical Imiquimod therapy for 12 weeks.
DRUGPlacebo cream
Patients receive topical Doritin therapy for 12 weeks
PROCEDUREFulguration
Surgical Excision and Fulguration of condyloma
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in recurrence rates between the two arms | 12 months | Recurrence is evaluated by clinical examination (proctoscopy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD4 (cluster of differentiation 4) cell count | 12 months | Influence of CD4 cell count in the subgroup of HIV positive patients |
Countries
Austria
Contacts
Primary ContactIrmgard E Kronberger, MD
Backup ContactSascha Czipin, MD
Outcome results
None listed