Ignite Creation Date:
2024-05-05 @ 9:40 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00936533
Status:
UNKNOWN
Last Update Posted:
2011-03-09
First Post:
2009-07-08
Brief Title:
Botulinumtoxin A Treatment in Epidermolysis Bullosa Simplex and Pachyonychia Congenita
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
Botulinumtoxin A Treatment in Epidermolysis Bullosa Simplex and Pachyonychia Congenita - a Double-blind Placebo-controlled Phase II Proof of Concept Study
Status:
UNKNOWN
Status Verified Date:
2011-03
Last Known Status:
RECRUITING
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:
This study evaluates the clinical effect of foot injection of the bacteria protein Botulinum toxin A on plantar pain in patients with EBS epidermolysis bullosa simplex or PC pachyonychia congenita
Detailed Description:
Epidermolysis bullosa simplex EBS is the most common subtype of epidermolysis bullosa and mutations in keratin genes KRT 514 are responsible for this condition Painful blisters and keratoderma of the feet are common and the blisters in EBS typically get worse in the summer due to sweating and increased environmental heat Since 2010 also the related condition pachyonychia congenita PC is included in the study The primary objective of the study is to evaluate the clinical effect of Botulinum toxin A Dysport injected in the foot on plantar pain in patients with EBS or PC Quality of life pain in feet effect duration plantar sweating and safety of the treatment will also be studied
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT number 2009-010763-17 | None | None | None |