Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis

Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00309621

Enrollment

250

Registered

2006-04-03

Start date

2006-04-30

Completion date

2007-05-31

Last updated

2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Dermatoses

Keywords

Hand Dermatoses,, hand dermatitis, hand eczema, chronic hand dermatitis, retinoid

Brief summary

Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.

Detailed description

For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of aggravating factors such as allergens and irritants, no registered systemic treatment is available. Current systemic treatment options consist in the off-label use of systemic immune suppressants, such as cyclosporine, methotrexate. Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life and working ability. A huge proportion of the population suffers for more than a decade, and job losses are a frequent consequence. This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy study BAP00089.

Interventions

DRUGalitretinoin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Chronic hand dermatitis, rated as severe by physicians global assessment, present for at least 6 months, that has not responded to the avoidance of allergens and irritants and the use of topical steroids

Exclusion criteria

* female of childbearing potential, unless participating in a pregnancy prevention program * psoriasis * active major psychiatric condition

Design outcomes

Primary

Measure	Time frame
Radiological investigations (bone density, x-ray)	—
Safety:	—
Adverse Events	—
Safety Laboratory	—

Secondary

Measure	Time frame
Physicians Global Assessment	—
modified Total Lesion Symptom Score	—
Patients Global Assessment	—
Patient Defined Outcomes	—

Countries

Canada, Germany, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026