Hand eczema
Conditions
Interventions
Trade Name: Toctino / Alitretinoin / 9-cis-retinoic acid
Product Name: Alitretinoin
Product Code: 9-cis-retinoic acid
Pharmaceutical Form: Capsule
Trade Name: Imuran / Azasan / Azathioprine
Product N
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age = 18 years and = 75 years - Severe chronic non-hyperkeratotic hand eczema for a minimum duration of 3 months as defined by a Physician Global Assessment (PGA) using a validated Photoguide - Refractory to standard therapy, defined as: -> Patients received treatment with topical corticosteroids of class II or higher for at least 8 weeks within 3 months before enrolment, with either no response or a transient response -> Patients had also received standard skin care, including emollients and barrier protection as appropriate, without significant improvement -> Patients had avoided irritants and allergens, if identified, without significant improvement - Women of childbearing potential are required to use at least two forms of contraception for at least 1 month before starting treatment, during treatment, and for at least 1 month after finishing treatment; these women are required to take monthly pregnancy tests - Not previously treated with alitretinoin or azathioprine - Able to provide written informed consent - Able to speak and read the Dutch language Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: General criteria prior to randomization - Hyperkeratotic palmar eczema as defined by the Danish Contact Dermatitis Group - Patients with predominantly atopic dermatitis, in which the hands are also involved. Patients with mild atopic dermatitis, in which the hands are mainly affected are eligible for inclusion. - Psoriasis - Active bacterial, fungal, or viral infection of the hands - Pregnant/lactating or planning to become pregnant during the study period - Treatment with systemic medication or UV radiation within the previous 4 weeks - Use of topical corticosteroids > class II within 1 week before enrolment - Mentally incompetent - Currently active depression - Immunocompromised status - Known or suspected allergy to ingredients in the study medications - Inclusion in a study of an investigational drug within 60 days prior to start of treatment - Current malignancy (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix) - Current active pancreatitis - Living vaccine (including bacillus Calmette-Guérin (BCG), varicella, measles, mumps, rubella, yellow fever, oral polio and oral typhoid) in the last 2 weeks or the planned application of such a vaccine during the study period - Evidence of alcohol abuse or drug addiction - Chronic or recurrent infectious diseases - Contact sensitizations with clinical relevance to the hands, in which avoidance of exposure is unclear - Hypervitaminosis A due to the use of vitamin A supplements containing >2000 IU - Use of drugs with potential to change the effective dosis of study drugs within the previous 2 weeks Laboratory exclusion criteria post randomization - Alanine aminotransferase (ALAT) and /or aspartate aminotransferase (ASAT) values > 200% of the upper limit of normal - Impaired renal function as indicated by a clinically relevant abnormal creatinine value (to be determined by investigator or treating physician) - Anemia as indicated by a clinically relevant lowered hemoglobin value (to be determined by investigator or treating physician) Alitretinoin specific - Triglycerides > 200% of the upper limit of normal, - Cholesterol or low density lipoprotein (LDL) cholesterol values > 200% of the upper limit of normal - Uncontrolled hypothyroidism (to be determined by investigator or treating physician) Azathioprine specific - Patients with low or absent thiopurine methyltransferase (TPMT) activity (defined in our center as <52 nmol/gHb/hour, combined with genotyping showing homozygous of compound heterozygous mutations) and a subsequent risk for life-threatening myelotoxicity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint for efficacy is response to treatment, defined as an improvement of = 2 steps on the Physician Global Assessment (PGA), developed by Ruzicka et al, after 24 weeks of treatment. ;Timepoint(s) of evaluation of this end point: 24 weeks;Main Objective: To compare the efficacy of alitretinoin and azathioprine in the treatment of severe chronic non-hyperkeratotic hand eczema.;Secondary Objective: To compare time to response, to compare health related quality of life, to compare improvement in severity of hand eczema assessed by the patient, to compare safety. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are improvement in: mean PGA after 12 and 24 weeks, the Hand Eczema Severity Index (HECSI) score, the Health related QoL questionnaire for hand eczema (QOLHEQ), and a Patient Global Assessement (PaGA) of improvement. Adverse events will be registered, as well as time to response.;Timepoint(s) of evaluation of this end point: Improvement in: Mean PGA: 12 and 24 weeks. HECSI: 4, 8, 12 and 24 weeks. QOLHEQ: 12 and 24 weeks. PaGA: 12 and 24 weeks. Adverse events and time to response at every visit. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Dermatology
University Medical Center Groningen
Outcome results
None listed