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Efficacy of Oral Alitretinoin Versus Oral Azathioprine in Patients With Severe Chronic Non-hyperkeratotic Hand Eczema. A Randomized Prospective Open-label Trial With Blinded Outcome Assessment (NCT03026907)

The purpose of this study is to compare the efficacy of alitretinoin and azathioprine in the treatment of patients with severe chronic non-hyperkeratotic hand eczema.
  • Drug: Alitretinoin
    Oral alitretinoin capsule of 30mg once daily for a total of 24 weeks.
    • Toctino
    • 9-cis-retinoic acid
    • ATC code: D11AH04
  • Drug: Azathioprine
    Oral azathioprine tablets twice daily in a dose of 1.5 or 2.5mg/kg/day, depending on the thiopurine methyltransferase (TPMT) activity.
    • Imuran
    • Azafalk
    • ATC code: L04AX01
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Age ≥ 18 years and ≤ 75 years
  • Severe or very 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
  • Able to provide written Informed Consent
  • Able to speak and read the Dutch language
Exclusion Criteria:
  • General criteria prior to randomization
  • Treatment with alitretinoin or azathioprine in the previous 3 months
  • 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
  • Mentally incompetent
  • 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 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) 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

1 locations

Netherlands (1)
  • University Medical Center Groningen
    recruiting
    Groningen, Netherlands, 9700RB
Status:
recruiting
Type:
Interventional
Phase:
Start:
30 April, 2016
Updated:
17 January, 2017
Participants:
116
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