Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema (HANDEL)

Stiefel

Status and phase: Completed; Phase 3

Conditions: Eczema

Treatments: Drug: alitretinoin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00817063

BAP01346 (Other Identifier)

NCT00817063 (Registry Identifier)

117183

Details and patient eligibility

About

The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids.

Full description

Chronic hand eczema (CHE)is a distressing disease that poses difficult problems for dermatologists. CHE leads to considerable work-absenteeism, disability and exclusion from labour market. Conventional treatments, including highly potent topical steroids, yield often unsatisfactory results. This study investigates the efficacy and safety of oral alitretinoin, a retinoid, in patients who have not responded to avoidance of causative factors, such as contact allergens and skin irritants, non-medicated skin care and highly potent topical steroids. Eligible patients are randomly assigned to receive alitretinoin or a placebo.

Enrollment: 599 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis
• rated as severe by the physician
• unresponsive to highly potent topical corticosteroids, such as clobetasol

Exclusion criteria

• patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants
• patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances
• patients with psoriasis lesions
• active fungal, bacterial or viral infections of the hands
• female patients who are pregnant or breastfeeding
• female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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599 participants in 2 patient groups

Alitretinoin

Experimental group

Description:

Patients will receive alitretinoin 30mg capsule for up to 24 weeks

Treatment:

Drug: alitretinoin

Placebo

Experimental group

Description:

Patients will receive placebo 30mg capsule for up to 24 weeks

Treatment:

Drug: Placebo