Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124475
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2005-07-26
Brief Title:
Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Sponsor:
Basilea Pharmaceutica
Organization:
Basilea Pharmaceutica
Study Overview
Official Title:
Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine the therapeutic effect of alitretinoin a retinoid on severe therapy refractory chronic hand dermatitis
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None