Follow-up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis

• Sponsor: Basilea Pharmaceutica (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00124436
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Duration (Months): 23.1
• Patients Per Site Per Month: 13

Study Details

Study Description

Brief Summary

Patients who have been treated in study protocol BAP089 may have responded to treatment, and subsequently relapsed to >75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. Also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.

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

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Official Title: Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Feb 1, 2007

Outcome Measures

Primary Outcome Measures

1. Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24 []

Secondary Outcome Measures

1. Patient's global assessment []

2. Extent of disease []

3. Time to respond []

4. Modified total lesion symptom score []

5. at week 12 or 24 []

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Previous participation in protocol BAP089

• Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease

Exclusion Criteria:

• Female patients who are pregnant or who want to become pregnant

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Ruzicka	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: NCT00124436
• Other Study ID Numbers: BAP00091
• First Posted: Jul 28, 2005
• Last Update Posted: Jul 19, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Patients who have been enrolled in study protocol BAP089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed
• Additional relevant MeSH terms: Dermatitis; Skin Diseases; Hand Dermatoses; Alitretinoin

Study Results

No Results Posted as of Jul 19, 2010