Clinical trial · Interventional
Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial
Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anogenital Human Papillomavirus Infection | — | UNRESOLVED | — |
| Condyloma Anal | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulguration | Procedure | — | UNRESOLVED |
| Imiquimod 5% cream | Drug | Imiquimod | ALIAS |
| Placebo cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional Arm
- description
- Imiquimod 5% cream therapy Fulguration
- interventionNames
- Drug: Imiquimod 5% cream
- Procedure: Fulguration
- type
- PLACEBO_COMPARATOR
- label
- Placebo Arm
- description
- Placebo cream therapy Fulguration
- interventionNames
- Drug: Placebo cream
- Procedure: Fulguration
Primary outcomes (1)
- measure
- Difference in recurrence rates between the two arms
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available