Cervical Intraepithelial Neoplasia-II Clinical Trial
Official title:
The Effect of Medical Grade Honey (L-Mesitran) for Cervical Intraepithelial Neoplasia-II
The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus and an increase inthe normalization of CIN II lesions compared to expectant management.
In this pilot study, we will include 60 patients with newly diagnosed CIN II. Patients will be counseled according to standard guidelines between a LLETZ, imiquimod or expectant management. 1 Patients choosing for expectant management will be asked to participate in the study and treatment with medical grade honey. Patients choosing imiquimod or LLETZ will be asked for the control arm. Follow-up assessment takes place in accordance with the national guideline (first check-up is after 6 months). 1 In addition, swabs for vaginal microbiota analysis will be taken at 0 and 6 months. Immunohistochemical stainings for the local immune infiltrate will be performed on biopsies taken during regular colposcopy at t=0. This exploratory study assesses the potential effect of honey, the optimal dosage and provides insight into its mechanisms of action. ;