Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472901
Status:
COMPLETED
Last Update Posted:
2011-10-05
First Post:
2007-05-10
Brief Title:
Phase III Trial of CUV1647 in Polymorphic Light Eruption PLE
Sponsor:
Clinuvel Pharmaceuticals Limited
Organization:
Clinuvel Pharmaceuticals Limited
Study Overview
Official Title:
A Phase III Randomised Double-Blind Placebo Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of CUV1647 in Patients Suffering From Polymorphic Light Eruption PLE
Status:
COMPLETED
Status Verified Date:
2011-10
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 this study is to determine whether the afamelanotide CUV1647 formulation is effective in preventing PLE episodes or reducing the severity of PLE symptoms in patients with a well documented history of the disease The study also aims to determine whether treatment with afamelanotide CUV1647 can reduce the use of rescue medication in this group
Detailed Description:
Polymorphic Light Eruption PLE is a prevalent photosensitivity disorder occurring in up to 20 of the European and US populations and up to 5 of the Australian population The disease is characterised by a rash that is intensely itchy with blisters bumps and patches presenting on areas of the skin that have been exposed to the sun There is a lack of effective treatment available for the condition but the most common available forms of therapy include sun avoidance and the use of the use of steroids andor phototherapy
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