Status:
COMPLETED
Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)
Lead Sponsor:
Clinuvel Pharmaceuticals Limited
Conditions:
Polymorphic Light Eruption (PLE)
Eligibility:
All Genders
18-70 years
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 docum...
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 character...
Eligibility Criteria
Inclusion
- Aged 18 - 70 years at inclusion.
- Well documented history of moderate/severe PLE as diagnosed/confirmed by a photodermatologist or photobiologist. Newly diagnosed patients with moderate/severe PLE can be included if numbers of established patients are limited provided their diagnosis is confirmed by a photodermatologist or photobiologist.
- Recurrent episodes that occur at least once a year, developing in own country (to exclude patients affected only when traveling to sunnier climates).
- Have given written informed consent to participate in the study.
Exclusion
- Personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi.
- Current Bowen's Disease, basal cell carcinoma, squamous cell carcinoma or other malignant skin lesions.
- Documented history of other photosensitive conditions.
- Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating.
- Females of child-bearing potential that are not using adequate contraceptive measures.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00472901
Start Date
May 1 2007
End Date
September 1 2010
Last Update
October 5 2011
Active Locations (3)
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1
St Vincents Hospital
Melbourne, Australia
2
Medical University of Vienna
Vienna, Austria, A1090
3
Hope Hospital
Manchester, United Kingdom