Alitretinoin vs Azathioprine in Severe Non-hyperkeratotic Hand Eczema

NCT03026907 | Unknown Phase 3

• 1 other identifier: 52232
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Eczema

Keywords

Alitretinoin; Azathioprine; Hand eczema

Outcome Measures

Primary Outcomes (1)

• Response to treatment/hand eczema severity (Photoguide)

  24 weeks (end of treatment)

Secondary Outcomes (8)

• Response to treatment/hand eczema severity (Photoguide)

  12 weeks

• Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)

  Week 4, 8, 12, 24

• Time to response

  Week 4, 8, 12, 24

• Patient reported improvement (Patient Global Assessment, PaGA)

  Week 12 and 24

• Safety and tolerability (adverse events)

  Up to 24 weeks

Study Arms (2)

Alitretinoin

ACTIVE COMPARATOR

Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with alitretinoin.

Drug: Alitretinoin

Azathioprine

ACTIVE COMPARATOR

Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with azathioprine.

Drug: Azathioprine

Interventions

Alitretinoin DRUG

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

Also known as: Toctino, 9-cis-retinoic acid, ATC code: D11AH04

Alitretinoin

Azathioprine DRUG

Oral azathioprine tablets twice daily in a dose of 1.5 or 2.5mg/kg/day, depending on the thiopurine methyltransferase (TPMT) activity.

Also known as: Imuran, Azafalk, ATC code: L04AX01

Azathioprine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

RECRUITING

MeSH Terms

Interventions

Alitretinoin; Azathioprine

Intervention Hierarchy (Ancestors)

Tretinoin; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• MLA Schuttelaar, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MLA Schuttelaar, MD, PhD

CONTACT

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

JAF Oosterhaven, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, dermatologist, MD, PhD

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: January 20, 2017
• Study Start: May 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)