Trials / Unknown
UnknownNCT03289260
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
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Medical University Innsbruck · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Imiquimod 5% cream | Patients receive topical Imiquimod therapy for 12 weeks. |
| DRUG | Placebo cream | Patients receive topical Doritin therapy for 12 weeks |
| PROCEDURE | Fulguration | Surgical Excision and Fulguration of condyloma |
Timeline
- Start date
- 2021-11-15
- Primary completion
- 2024-11-15
- Completion
- 2024-11-15
- First posted
- 2017-09-20
- Last updated
- 2020-09-23
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT03289260. Inclusion in this directory is not an endorsement.