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Alitretinoin vs Azathioprine in Severe Non-hyperkeratotic Hand Eczema | Clinical Trials | Clareo Health

UNKNOWNPHASE3

Alitretinoin vs Azathioprine in Severe Non-hyperkeratotic Hand Eczema

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

NCT03026907•University Medical Center Groningen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+19 more criteria

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

Key Dates

Start Date

May 1, 2016

Primary Completion Date

December 1, 2019

Completion Date

December 1, 2019

Last Updated

May 4, 2018

Enrollment

116

ESTIMATED participants

Conditions

Hand Eczema

Interventions

Alitretinoin

DRUG

Azathioprine

DRUG

Contacts

MLA Schuttelaar, MD, PhD

CONTACT

+31503612520 m.l.a.schuttelaar@umcg.nl

JAF Oosterhaven, MD

CONTACT

+31503610795 j.a.f.oosterhaven@umcg.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Alitretinoin vs Azathioprine in Severe Non-hyperkeratotic Hand Eczema

Inclusion Criteria

Exclusion Criteria

Immune Signature of Chronic Hand Eczema Unveiled by Spatial Transcriptomics and Single-Cell Proteomics

Prevention of Hand Eczema Among Workers in the Fishing Industry in Greenland

Topical Ruxolitinib Evaluation in Chronic Hand Eczema

Satisfaction Survey - Cicaplast Mains

Hand Eczema in the Health Care Sector

Chronic Hand Eczema - Self-management and Prognosis