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Trial record 2 of 161 for:    Recruiting, Not yet recruiting, Available Studies | "Eczema"

Alitretinoin vs Cyclosporine in Severe Recurrent Vesicular Hand Eczema (ALICsA)

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ClinicalTrials.gov Identifier: NCT03026946
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
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 cyclosporine in the treatment of patients with severe recurrent vesicular hand eczema.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Oral Alitretinoin Versus Oral Cyclosporine in Patients With Severe Recurrent Vesicular Hand Eczema. A Randomized Prospective Open-label Trial With Blinded Outcome Assessment
Actual Study Start Date : May 29, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Alitretinoin
Patients with severe recurrent vesicular 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: Cyclosporin A
Patients with severe recurrent vesicular hand eczema, randomized to treatment with cyclosporin A.
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.
Other Name: Neoral




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 ]


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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 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
  • 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)

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

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): NCT03026946


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

Locations
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
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: MLA Schuttelaar, MD, PhD University Medical Center Groningen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marie-Louise A Schuttelaar, MD, PhD, MD, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03026946     History of Changes
Other Study ID Numbers: 54659
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Cyclosporins
Cyclosporine
Tretinoin
Alitretinoin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antineoplastic Agents
Keratolytic Agents