Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis - Full Text View

Purpose

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	Intervention	Phase
Hand Dermatoses	Drug: alitretinoin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Skin Conditions

Drug Information available for: Alitretinoin

U.S. FDA Resources

Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:

Safety:
Adverse Events
Safety Laboratory
Radiological investigations (bone density, x-ray)

Secondary Outcome Measures:

Physicians Global Assessment
modified Total Lesion Symptom Score
Patients Global Assessment
Patient Defined Outcomes

Estimated Enrollment:	250
Study Start Date:	April 2006
Study Completion Date:	May 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309621

Locations

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
Canada

Quebec, Canada, G1J1X7
Germany

Berlin, Germany, 13439

Berlin, Germany, 12353

Frankfurt, Germany, 60326

Hamburg, Germany, 22143

Hamburg, Germany, 20246

Hamburg, Germany, 20354
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
Poland

Gdansk, Poland

Krakow, Poland, 31-462

Lublin, Poland

Opole, Poland, 45-372

Szcecin, Poland

Wroclaw, Poland

Sponsors and Collaborators

Basilea Pharmaceutica

Investigators

Principal Investigator:

Thomas Diepgen, MD

Univ. Heidelberg

More Information

Publications:

Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Blome C, Maares J, Diepgen T, Jeffrustenbach S, Augustin M. Measurement of patient-relevant benefits in the treatment of chronic hand eczema--a novel approach. Contact Dermatitis. 2009 Jul;61(1):39-45.

ClinicalTrials.gov Identifier:	NCT00309621 History of Changes
Other Study ID Numbers:	BAP00626
Study First Received:	March 30, 2006
Last Updated:	July 16, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Canada: Health Canada Poland: Ministry of Health

Keywords provided by Basilea Pharmaceutica:

Hand Dermatoses,
hand dermatitis
hand eczema
chronic hand dermatitis
retinoid

Additional relevant MeSH terms:

Dermatitis
Hand Dermatoses
Skin Diseases
Alitretinoin

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013