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

February 24, 2019 updated by: Marie-Louise A Schuttelaar, MD, PhD, University Medical Center Groningen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Neoral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response to treatment/hand eczema severity (Photoguide)
Time Frame: 24 weeks (end of treatment)
24 weeks (end of treatment)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: MLA Schuttelaar, MD, PhD, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2017

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 24, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54659

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be published anonymously and will not be possible to trace back to individual participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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