Alitretinoin vs Cyclosporine in Severe Recurrent Vesicular Hand Eczema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-29

Study Completion Date

2022-07-31

Brief Summary

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The purpose of this study is to compare the efficacy of alitretinoin and cyclosporine in the treatment of patients with severe recurrent vesicular hand eczema.

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Detailed Description

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Conditions

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Hand Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Alitretinoin

Patients with severe recurrent vesicular hand eczema, randomized to treatment with alitretinoin.

Group Type ACTIVE_COMPARATOR

Alitretinoin

Intervention Type DRUG

Oral alitretinoin capsule of 30mg once daily for a total of 24 weeks.

Cyclosporin A

Patients with severe recurrent vesicular hand eczema, randomized to treatment with cyclosporin A.

Group Type ACTIVE_COMPARATOR

cyclosporin A

Intervention Type DRUG

Oral cyclosporine A start dose 5 mg/kg/day (split in 2 doses), decreasing the dose after 8 weeks to 3 - 3.5 mg/kg/day (split in 2 doses). The treatment period is 24 weeks.

Interventions

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Alitretinoin

Oral alitretinoin capsule of 30mg once daily for a total of 24 weeks.

Intervention Type DRUG

cyclosporin A

Oral cyclosporine A start dose 5 mg/kg/day (split in 2 doses), decreasing the dose after 8 weeks to 3 - 3.5 mg/kg/day (split in 2 doses). The treatment period is 24 weeks.

Intervention Type DRUG

Other Intervention Names

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Toctino 9-cis-retinoic acid ATC code: D11AH04 Neoral

Eligibility Criteria

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Inclusion Criteria

Age ≥ 18 years and ≤ 75 years

* Severe or very severe recurrent vesicular 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 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

General criteria prior to randomization

* Treated with alitretinoin or cyclosporine in the previous 3 months
* Other morphologic types of hand eczema as defined by the Danish Contact Dermatitis Group
* 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
* 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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No