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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309621
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : July 19, 2010
Information provided by:
Basilea Pharmaceutica

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.

Condition or disease Intervention/treatment Phase
Hand Dermatoses Drug: alitretinoin Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis
Study Start Date : April 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Safety:
  2. Adverse Events
  3. Safety Laboratory
  4. Radiological investigations (bone density, x-ray)

Secondary Outcome Measures :
  1. Physicians Global Assessment
  2. modified Total Lesion Symptom Score
  3. Patients Global Assessment
  4. Patient Defined Outcomes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00309621

Canada, Alberta
Edmonton, Alberta, Canada, T6G2G3
Canada, British Columbia
Vancouver, British Columbia, Canada, V5O3Y1
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3C1R4
Canada, Ontario
Hawkesbury, Ontario, Canada, K6A1A1
London, Ontario, Canada, N6H1S9
Markham, Ontario, Canada, L3P1A8
Oakville, Ontario, Canada, L6J7W5
Canada, Quebec
Montreal, Quebec, Canada, H3X1V6
Sheerbroke, Quebec, Canada, J1H1Z1
Quebec, Canada, G1J1X7
Berlin, Germany, 12353
Berlin, Germany, 13439
Frankfurt, Germany, 60326
Hamburg, Germany, 20246
Hamburg, Germany, 20354
Hamburg, Germany, 22143
Abt. Klinische Sozialmedizin
Heidelberg, Germany, 69115
Ibbenbüren, Germany, 49477
Köln, Germany, 51143
Lübeck, Germany, 23558
Mönchengladbach, Germany, 41061
München, Germany, 81375
Münster, Germany, 48143
Osnabrück, Germany, 49078
Potsdam, Germany, 14482
Viersen, Germany, 41747
Wuppertal, Germany, 42275
Gdansk, Poland
Krakow, Poland, 31-462
Lublin, Poland
Opole, Poland, 45-372
Szcecin, Poland
Wroclaw, Poland
Sponsors and Collaborators
Basilea Pharmaceutica
Principal Investigator: Thomas Diepgen, MD Univ. Heidelberg

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00309621     History of Changes
Other Study ID Numbers: BAP00626
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: July 19, 2010
Last Verified: July 2010

Keywords provided by Basilea Pharmaceutica:
Hand Dermatoses,
hand dermatitis
hand eczema
chronic hand dermatitis

Additional relevant MeSH terms:
Skin Diseases
Hand Dermatoses
Antineoplastic Agents