title: Evaluation of topically applied trans-retinoic acid in the treatment of cervical intraepithelial lesions.
abstract: The prevention and/or suppression of preneoplastic foci in animals has been convincingly demonstrated with the use of a variety of compounds, including retinoids. We report here a phase I/II trial of beta-trans-retinoic acid delivered via a collagen sponge/diaphragm insert for neoplasia of the cervix. Eighteen patients with biopsy-proved grades 2 and 3 cervical intraepithelial neoplasia underwent four consecutive daily applications of trans-retinoic aicd to the cervix. Conization of the cervix was performed 4 weeks later. Significant vaginal toxicity in 10 of 18 (55%) patients was unrelated to the concentration or carrying media of the drug. A reduction in size of the intraepithelial lesion was noted by colposcopy in six of 18 (33%) patients with complete resolution of disease at conization in two patients. A new delivery system designed to avoid vaginal toxicity while defining the optimal concentration and dosing schedule for these patients is currently under investigation.
mesh_terms: D000287:Administration, Topical; D002584:Cervix Uteri / Q000601:surgery; D002986:Clinical Trials as Topic; D003094:Collagen; D003127:Colposcopy; D003273:Contraceptive Devices; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D014212:Tretinoin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000601:surgery; D014621:Vagina / Q000187:drug effects
chemical_list: D014212:Tretinoin; D003094:Collagen