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Trial record 12 of 965 for:    eczema

Alitretinoin vs Azathioprine in Severe Non-hyperkeratotic Hand Eczema (ALIAZ)

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ClinicalTrials.gov Identifier: NCT03026907
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Marie-Louise A Schuttelaar, MD, PhD, University Medical Center Groningen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hand Eczema Drug: Alitretinoin Drug: Azathioprine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Alitretinoin
Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with alitretinoin.
Drug: Alitretinoin
Oral alitretinoin capsule of 30mg once daily for a total of 24 weeks.
Other Names:
  • Toctino
  • 9-cis-retinoic acid
  • ATC code: D11AH04

Active Comparator: Azathioprine
Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with azathioprine.
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.
Other Names:
  • Imuran
  • Azafalk
  • ATC code: L04AX01




Primary Outcome Measures :
  1. Response to treatment/hand eczema severity (Photoguide) [ Time Frame: 24 weeks (end of treatment) ]

Secondary Outcome Measures :
  1. Response to treatment/hand eczema severity (Photoguide) [ Time Frame: 12 weeks ]
  2. Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI) [ Time Frame: Week 4, 8, 12, 24 ]
  3. Time to response [ Time Frame: Week 4, 8, 12, 24 ]
  4. Patient reported improvement (Patient Global Assessment, PaGA) [ Time Frame: Week 12 and 24 ]
  5. Safety and tolerability (adverse events) [ Time Frame: Up to 24 weeks ]
  6. Cost-utility. QALY's: registered direct/indirect costs, combined with EQ-5D outcome [ Time Frame: Week 12 and 24 ]
  7. Cost-effectiveness: registered direct/indirect costs combined with the primary and secondary effectiveness outcomes (Photoguide/HECSI) [ Time Frame: Week 12 and 24 ]
  8. Quality of Life: questionnaire. [ Time Frame: Week 12 and 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026907


Contacts
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Contact: MLA Schuttelaar, MD, PhD +31503612520 m.l.a.schuttelaar@umcg.nl
Contact: JAF Oosterhaven, MD +31503610795 j.a.f.oosterhaven@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700RB
Contact: MLA Schuttelaar, MD, PhD    +31503612520    m.l.a.schuttelaar@umcg.nl   
Contact: JAF Oosterhaven, MD    +31503610795    j.a.f.oosterhaven@umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: MLA Schuttelaar, MD, PhD University Medical Center Groningen

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Responsible Party: Marie-Louise A Schuttelaar, MD, PhD, Principal investigator, dermatologist, MD, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03026907     History of Changes
Other Study ID Numbers: 52232
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published anonymously and will not be possible to trace back to individual participants.

Keywords provided by Marie-Louise A Schuttelaar, MD, PhD, University Medical Center Groningen:
Alitretinoin
Azathioprine
Hand eczema

Additional relevant MeSH terms:
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Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Azathioprine
Alitretinoin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Dermatologic Agents