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Completed

NCT Number: NCT00309621

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

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.

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Key information

Conditions

Hand Dermatoses Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alitretinoin

Drug

Primary outcomes

  1. Safety:

  2. Adverse Events

  3. Safety Laboratory

  4. Radiological investigations (bone density, x-ray)

Secondary outcomes

  1. Physicians Global Assessment

  2. modified Total Lesion Symptom Score

  3. Patients Global Assessment

  4. Patient Defined Outcomes

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 3, 2006
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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