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.
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Full eligibility criteria for NCT03026907
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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.
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
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
All locations for NCT03026907
University Medical Center Groningen
Groningen, Netherlands, 9700RB
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View full eligibility
Tris trial is registered with FDA with number: NCT03026907. The sponsor of the trial is University Medical Center Groningen and it is looking for 116 volunteers for the current phase.
Official trial title: 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
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