Lichen Planus Mucosae at USZ, Efficacy of Oral Alitretinoin

University of Zurich (UZH)

Status and phase

Unknown

Phase 2

Conditions

Lichen Planus (LP)

Treatments

Drug: alitretinoin

Study type

Interventional

Funder types

Other

Identifiers

NCT01538732

LISZT-2012

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Aged 18 to 75 years
MLP for at least 3 months
Disease activity according to Escudier score of 10 points or greater or erosive lesion of any score
Refractory to standard topical therapy
Consensus to a 2 weeks wash-out period of topical steroids before starting study treatment

Exclusion criteria

Unable to comply with the requirements of the study
Pregnant or lactating women
Female patients of childbearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously under supervision of the investigator or a gynecologist
Active hepatitis and/or vaccination against hepatitis A/B during the last 4 weeks
Adequate control of the disease by standard topical therapy and standard topical corticosteroid therapy
Known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component
Patients treated with any of the following treatments 4 weeks before the start of study treatment:
1. systemic drugs: corticosteroids, immunosuppressants, methotrexate
2. phototherapy
Treatment with any systemic or topical retinoids within 1 year or 1 month, respectively, before start of study treatment or treatment with systemic retinoids for treatment for MLP at any time
coexistence of any serious medical condition which, in the opinion of the investigator, may interfere with the safety of the patient, including
1. hepatic insufficiency (alanine aminotransferase and /or aspartate aminotransferase values > 2.5 x ULN)
2. severe renal failure
3. uncontrolled hypertriglyceridemia (triglycerides >150 % of the upper limit of normal),
4. uncontrolled hypercholesterolemia (cholesterol or low density lipoprotein (LDL) cholesterol values > 1.5 x ULN
5. Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin
6. Uncontrolled hypothyroidism
7. Hypervitaminosis A
8. Active major psychiatric disorder including depression and suicidal ideation
Concomitant medications such as systemic tetracyclines, CYP3A4 inhibitors such as ketoconazole, Vitamin A or St. John's Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before start of study treatment
Trial participation within 2 months before start of study treatment (3 months for biologics)