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Alitretinoin vs Cyclosporine in Severe Recurrent Vesicular Hand Eczema

NCT03026946 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2019-02-26

No results posted yet for this study

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.

Conditions

  • Hand Eczema

Interventions

DRUG

Alitretinoin

Oral alitretinoin capsule of 30mg once daily for a total of 24 weeks.

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.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • MLA Schuttelaar, MD, PhD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-29
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03026946 on ClinicalTrials.gov