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 III

MedlinePlus related topics:

Skin Conditions

ChemIDplus related topics:

9-cis-Retinoic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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

	Quebec, Canada, G1J1X7

Canada, Alberta

	Edmonton, Alberta, Canada, T6G2G3

Canada, British Columbia

	Vancouver, British Columbia, Canada, V5O3Y1

Canada, Manitoba

	Winnipeg, Manitoba, Canada, R3C1R4

Canada, Ontario

	Markham, Ontario, Canada, L3P1A8

	Oakville, Ontario, Canada, L6J7W5

	London, Ontario, Canada, N6H1S9

	Hawkesbury, Ontario, Canada, K6A1A1

Canada, Quebec

	Montreal, Quebec, Canada, H3X1V6

	Sheerbroke, Quebec, Canada, J1H1Z1

Germany
	Abt. Klinische Sozialmedizin
	Heidelberg, Germany, 69115

	München, Germany, 81375

	Berlin, Germany, 12353

	Köln, Germany, 51143

	Osnabrück, Germany, 49078

	Wuppertal, Germany, 42275

	Berlin, Germany, 13439

	Hamburg, Germany, 20354

	Münster, Germany, 48143

	Mönchengladbach, Germany, 41061

	Hamburg, Germany, 22143

	Potsdam, Germany, 14482

	Lübeck, Germany, 23558

	Viersen, Germany, 41747

	Hamburg, Germany, 20246

	Ibbenbüren, Germany, 49477

	Frankfurt, Germany, 60326

Poland

	Krakow, Poland, 31-462

	Gdansk, Poland

	Opole, Poland, 45-372

	Wroclaw, Poland

	Szcecin, Poland

	Lublin, 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.

Study ID Numbers:	BAP00626
First Received:	March 30, 2006
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00309621
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

Study placed in the following topic categories:

Hand Dermatoses

Alitretinoin

Skin Diseases

Eczema

Dermatitis

Additional relevant MeSH terms:

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Basilea Pharmaceutica
Information provided by:	Basilea Pharmaceutica
ClinicalTrials.gov Identifier:	NCT00309621