Efficacy of oral alitretinoin versus oral cyclosporine in patients with moderate to very severe hand eczema. A randomized prospective open-label trial with blinded outcome assessment.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 78

Inclusion Criteria

- Age >= 18 years and <= 75 years
- Moderate, severe or very severe hand eczema for a minimum duration of 3
months as defined by a validated Photoguide
- Refractory to standard therapy, defined as:
o 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
o Patients had also received standard skin care, including emollients and
barrier protection as appropriate, without significant improvement
o Patients had avoided irritants and contact 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
- Able to provide written Informed Consent
- Able to speak and read the Dutch language

Exclusion Criteria

- Treated with alitretinoin or cyclosporine in the previous 3 months
- Patients with predominantly atopic dermatitis, in which the hands are also
involved. Patients with controlled atopic dermatitis, in which the hands are
mainly affected, are eligible for inclusion.
- Psoriasis of the hands
- 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. For systemic prednisolone; patients with treatment within the previous 2
weeks will be excluded
- Mentally incompetent
- Immunocompromised status
- Uncontrolled arterial hypertension (minimally 3 measurements). Systolic
pressure > 160 mmHg or diastolic pressure > 95 mmHg, despite starting
anti-hypertensive medication (first choice amlodipine 5 mg/day)
- 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
- Evidence of alcohol abuse or drug addiction
- Malabsorption
- Currently active gout
- Recurring convulsions/epilepsy
- 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
- Chronic or recurrent infectious diseases
- Contact sensitizations with clinical relevance to the hands, in which
exposure to allergens is not avoided.
- 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), Cyclosporine specific:
- Impaired renal function as indicated by a clinically relevant abnormal
creatinine value (to be determined by investigator or treating physician)
- Uremia
- Hyperkalemia
- Hyperuricemia in patients with a medical history of gout

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint for efficacy is response to treatment, defined as<br /><br>achieving clear/almost clear in the PGA (Physician Global Assessment)<br /><br>score, based on a validated Photographic Guide developed by Coenraads et al<br /><br>(16) at 24 weeks of treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are: improvement of >=2 steps on the PGA score, based on a<br /><br>validated Photographic Guide developed by Coenraads et al at 24 weeks of<br /><br>treatment; improvement in the Hand Eczema Severity Index (HECSI) score;<br /><br>improvement in the Health related Quality of Life questionnaire for hand eczema<br /><br>(QOLHEQ); and a Patient Global Assessement (PaGA) of improvement after 12 en 24<br /><br>weeks. Adverse events will be registered, as well as time to response.<br /><br>Furthermore, cost-utility, quality adjusted life years (QALYs) and<br /><br>cost-effectiveness will be assessed with the EQ-5D-5L questionnaire while<br /><br>monitoring treatment related costs.</p><br>