Lichen Planus (LP)Phase 2NCT01538732
Lichen Planus Mucosae at USZ, Efficacy of Oral Alitretinoin
A Phase 2 study testing alitretinoin in people with Lichen Planus (LP), run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lichen Planus (LP)
- What is being tested?
- alitretinoin
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- Patients treated with any of the following treatments 4 weeks before the start of study treatment:
- systemic drugs: corticosteroids, immunosuppressants, methotrexate
- 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
- hepatic insufficiency (alanine aminotransferase and /or aspartate aminotransferase values > 2.5 x ULN)
- severe renal failure
- uncontrolled hypertriglyceridemia (triglycerides >150 % of the upper limit of normal),
- uncontrolled hypercholesterolemia (cholesterol or low density lipoprotein (LDL) cholesterol values > 1.5 x ULN
- Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin
- Uncontrolled hypothyroidism
- Hypervitaminosis A
- 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)
Trial locations and contacts
1 site in 1 country.
Johanna Mangana, MD contact
Reinhard Dummer, Professor, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Division of Dermatology
Zurich, Canton of Zurich, 8091
About this study
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
- Conditions
- Lichen Planus (LP)
- Being tested
- alitretinoin
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alitretinoinDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of alitretinoin (Toctino®) based on the Escudier score of oral lesions at baseline and after 24 weeks of treatment.
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.
Measured: 6 months
Secondary outcomes (7)
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
Measured: 6 months
Assess the time to response (time to 50 % reduction in the total Escudier score)
Measured: 6 months
Assess oral mucosal changes regarding inflammation and erosions, at treatment end compared to baseline using Escudier
Measured: 6 months
Assess the number/distribution of extramucosal skin lesions (papules) of LP at treatment end compared to baseline
Measured: 6 months
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.
Measured: 4 weeks
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
Measured: 6 months
Assess safety of alitretinoin in mucosal lichen planus for the body as a whole
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lichen Planus (LP)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reinhard Dummer, Prof. MD, Principal investigator, University Hospital Zurich, Division of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538732
- Sponsor's protocol ID
- LISZT-2012
- Status last verified
- Mar 2012
- First submitted
- 20 Feb 2012
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kunz M, Urosevic-Maiwald M, Goldinger SM, Frauchiger AL, Dreier J, Belloni B, Mangana J, Jenni D, Dippel M, Cozzio A, Guenova E, Kamarachev J, French LE, Dummer R. Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study. J Eur Acad Dermatol Venereol. 2016 Feb;30(2):293-8. doi: 10.1111/jdv.13444. Epub 2015 Oct 27.
PubMed 26507685
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01538732
- Acronym / sponsor ID
- LISZT-2012
- Conditions
- Lichen Planus (LP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alitretinoin30mg 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 | Drug | – |
Primary outcome
Efficacy of alitretinoin (Toctino®) based on the Escudier score of oral lesions at baseline and after 24 weeks of treatment.
Time frame: 6 months
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.
7 secondary outcomes
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
Assess the time to response (time to 50 % reduction in the total Escudier score)
Time frame: 6 months
Assess oral mucosal changes regarding inflammation and erosions, at treatment end compared to baseline using Escudier
Time frame: 6 months
Assess the number/distribution of extramucosal skin lesions (papules) of LP at treatment end compared to baseline
Time frame: 6 months
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
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
Assess safety of alitretinoin in mucosal lichen planus for the body as a whole
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
- Derived from this study: PubMed 26507685Kunz M, Urosevic-Maiwald M, Goldinger SM, Frauchiger AL, Dreier J, Belloni B, Mangana J, Jenni D, Dippel M, Cozzio A, Guenova E, Kamarachev J, French LE, Dummer R. Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study. J Eur Acad Dermatol Venereol. 2016 Feb;30(2):293-8. doi: 10.1111/jdv.13444. Epub 2015 Oct 27.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna Mangana, MD contact
Reinhard Dummer, Professor, MD contact
Reinhard Dummer, Prof. MD principal investigator
University Hospital Zurich, Division of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alitretinoin in people with Lichen Planus (LP), run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanna Mangana, MD (johanna.mangana@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of alitretinoin (Toctino®) based on the Escudier score of oral lesions at baseline and after 24 weeks of treatment. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01538732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.