Efficacy of alitretinoin versus cyclosporine in patients with moderate to very severe hand eczema.

Phase 1

Active, not recruiting

Conditions: Hand eczema (HE) is a common condition with a 1-year period prevalence up to 10%. Systemic treatment with alitretinoin is registered for all clinical types of HE. However, it is especially effective in the hyperkeratotic subtype. Cyclosporine is often prescribed for HE in daily practice and has shown to be especially effective in patients with vesicular HE. The efficacy of cyclosporine in moderate to very severe HE could prove superior to that of alitretinoin.
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2015-003488-12-NL

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 78

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age = 18 years
- Moderate, severe or very severe hand eczema for a minimum duration of 3 months as defined by a Physician Global Assessment (PGA) using a validated Photoguide16
- 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

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 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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
• 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.
• Patients with known clinically relevant allergic contact dermatitis of the hands unless they had made a reasonable effort to avoid the contact allergen.
• 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. For systemic prednisolone; patients with treatment within the previous 2 weeks will be excluded
• Treated with alitretinoin or cyclosporine in the previous 3 months
• 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
• Evidence of alcohol abuse or drug addiction
• Chronic or recurrent infectious diseases
• Impaired renal function as indicated by a clinically relevant abnormal creatinine value (to be determined by investigator or treating physician)
• Alanine aminotransferase (ALAT) and /or aspartate aminotransferase (ASAT) values > 200% of the upper limit of normal
• 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

Cyclosporine specific:
• Uncontrolled arterial hypertension
• Renal insufficiency prior to start treatment
• Contraindicated co-medication (see SPC text)
• 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

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)
• Contraindicated co-medication of alitretinoin (see SPC text).