Alitretinoin vs Cyclosporine in Severe Recurrent Vesicular Hand Eczema

NCT03026946 | Unknown Phase 3

• 1 other identifier: 54659
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Eczema

Keywords

Alitretinoin; Cyclosporine A; 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 recurrent vesicular hand eczema, randomized to treatment with alitretinoin.

Drug: Alitretinoin

Cyclosporin A

ACTIVE COMPARATOR

Patients with severe recurrent vesicular hand eczema, randomized to treatment with cyclosporin A.

Drug: cyclosporin A

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

cyclosporin A DRUG

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.

Also known as: Neoral

Cyclosporin A

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 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

RECRUITING

Related Publications (1)

• Oosterhaven JAF, Schuttelaar MLA. Study protocol: efficacy of oral alitretinoin versus oral cyclosporine A in patients with severe recurrent vesicular hand eczema (ALICsA): a randomised prospective open-label trial with blinded outcome assessment. BMJ Open. 2018 Jul 11;8(7):e020192. doi: 10.1136/bmjopen-2017-020192.

  PMID: 29997136 DERIVED

MeSH Terms

Interventions

Alitretinoin; Cyclosporine

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; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

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: MD, PhD

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: January 20, 2017
• Study Start: May 29, 2017
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)