Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
1 other identifier
interventional
1,035
1 country
1
Brief Summary
The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2004
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 26, 2005
CompletedFirst Posted
Study publicly available on registry
July 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedMay 10, 2023
May 1, 2023
1.8 years
July 26, 2005
May 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Physicians global assessment
at week 12 or 24
Secondary Outcomes (5)
Response rate per treatment group
Modified total lesion symptom score
Patients global assessment
at week 12 or 24
Time to relapse
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Ruzicka, MD
Düsseldorf, 40225, Germany
Related Publications (1)
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. doi: 10.1001/archderm.140.12.1453.
PMID: 15611422BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Ruzicka, MD
University of Düsseldorf, Dermatological Hospital, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 26, 2005
First Posted
July 28, 2005
Study Start
December 1, 2004
Primary Completion
October 1, 2006
Study Completion
September 1, 2007
Last Updated
May 10, 2023
Record last verified: 2023-05