Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT01538732
Brief Summary:
This is a single center, prospective, open label, single arm, investigator initiated pilot study investigating the effect of alitretinoin on severe lichen planus with mucosal manifestations. The target population comprises patients with MLP for at least 3 months, with or without LP lesions on other areas of the skin, who are refractory to topical therapy and standard skin care, and who are otherwise in good health. Patients will be recruited at the outpatient clinic of the dermatology department, University hospital Zurich.The planned duration of the study is 2 years. A total of 20 patients will be included. Patients who meet enrolment criteria will receive 30mg alitretinoin, given orally as gelatin capsules, once daily for 24 weeks. Dose interruptions are permitted in response to adverse effects, consistent with use of retinoids and the product label.
Most clinical evaluations will be performed every 4 weeks. A safety follow-up visit is planned 4 weeks after the end of treatment. Further follow-up visits will be conducted 16 and 24 weeks after end of treatment in those patients meeting the primary endpoint
* Trial with medicinal product
Study:
NCT01538732
Study Brief:
Protocol Section:
NCT01538732