Lichen Planus (LP) Clinical Trial
Official title:
Single-Center, Prospective, Open Label, Single-arm Pilot Study Investigating the Efficacy and Safety of Alitretinoin in Patients Suffering From Severe Mucosal Lichen Planus.
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
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment