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

• Sponsor: Basilea Pharmaceutica (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00124475
• Collaborator: (none)
• Enrollment: 1,035
• Location: 1
• Duration (Months): 33
• Patients Per Site Per Month: 31.4

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.

Condition or Disease	Intervention/Treatment	Phase
Hand Dermatoses	Drug: alitretinoin	Phase 3

Detailed Description

Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment.

Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
• Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: Oct 1, 2006
• Actual Study Completion Date: Sep 1, 2007

Outcome Measures

Primary Outcome Measures

1. Physicians global assessment []

2. at week 12 or 24 []

Secondary Outcome Measures

1. Response rate per treatment group []

2. Modified total lesion symptom score []

3. Patients global assessment []

4. at week 12 or 24 []

5. Time to relapse []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis

• Lasting for 6 months since initial diagnosis

• Rated severe

• Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens

• Refractory to topical steroids

Exclusion Criteria:

• Female patients who are pregnant or want to become pregnant

• Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously

• Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Ruzicka, MD	Düsseldorf		Germany	40225

Sponsors and Collaborators

• Basilea Pharmaceutica

Investigators

• Principal Investigator: Thomas Ruzicka, MD, University of Düsseldorf, Dermatological Hospital, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ruzicka T, Larsen FG, Galewicz D, Horváth 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.

• ClinicalTrials.gov Identifier: NCT00124475
• Other Study ID Numbers: BAP00089
• First Posted: Jul 28, 2005
• Last Update Posted: Jul 19, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Chronic Hand Dermatitis
• Additional relevant MeSH terms: Dermatitis; Skin Diseases; Hand Dermatoses; Alitretinoin

Study Results

No Results Posted as of Jul 19, 2010