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Lichen Planus Mucosae at USZ, Efficacy of Oral Alitretinoin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01538732
First received: February 20, 2012
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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

Condition Intervention Phase
Lichen Planus (LP)
Drug: alitretinoin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Efficacy of alitretinoin (Toctino®) based on the Escudier score of oral lesions at baseline and after 24 weeks of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary objective is to determine the efficacy of alitretinoin (Toctino®) in reducing signs and symptoms of severe mucosal lichen planus with respect to the proportion of responders based on the, Escudier score of oral lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF). Response is defined as a 50 % reduction in the total Escudier score compared to the baseline values.


Secondary Outcome Measures:
  • Assess the efficacy of alitretinoin over time in reduction of signs (e.g. ulcerations) or symptoms (e.g. pruritus), using VAS for pruritus and pain and OHIP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Assess the time to response (time to 50 % reduction in the total Escudier score) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Assess oral mucosal changes regarding inflammation and erosions, at treatment end compared to baseline using Escudier [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Assess the number/distribution of extramucosal skin lesions (papules) of LP at treatment end compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Assess, if applicable, the inflammatory infiltrate in mucosa and skin before and during alitretinoin therapy determined by histopathology taken before and 4 weeks after initiation of study treatment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Determine the relapse rate (relapse is defined as Escudier score or number of extramucosal papules increasing back to > 75% of baseline) within 24 week follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Assess safety of alitretinoin in mucosal lichen planus for the body as a whole [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: alitretinoin
    30mg capsules (Alitretinoin)will be taken peroral once daily with a meal. Study treatment will be given for a total duration of up to 24 weeks
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538732

Contacts
Contact: Johanna Mangana, MD johanna.mangana@usz.ch
Contact: Reinhard Dummer, Professor, MD reinhard.dummer@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Dermatology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Reinhard Dummer, Prof. MD University Hospital Zurich, Division of Dermatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01538732     History of Changes
Other Study ID Numbers: LISZT-2012
Study First Received: February 20, 2012
Last Updated: March 19, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Lichen Planus
Lichenoid Eruptions
Skin Diseases
Skin Diseases, Papulosquamous
Alitretinoin
Tretinoin
Antineoplastic Agents
Dermatologic Agents
Keratolytic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014