Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT01538732
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01538732
Study Brief:
Protocol Section:
NCT01538732