An observational study in Polymorphic Light Eruption (PLE), sponsored by Clinuvel Pharmaceuticals Limited. Completed at 3 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-10-05.
Sponsored by Clinuvel Pharmaceuticals Limited · Observational
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.
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 and/or phototherapy.
79 studies on the registry are indexed under Exanthema; 12 are open to participants now.
This study's enrollment of 18 is below the median of 84 across 19 observational studies indexed under Exanthema.
Browse Exanthema studies →Clinuvel Pharmaceuticals Limited is the lead sponsor of 17 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with moderate/severe polymorphic light eruption (PLE)
Exclusion Criteria:
16mg implant
To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE
Time frame: 18 months
To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting
Time frame: 18 months
To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance
Time frame: 18 months
To evaluate whether afamelanotide (CUV1647) has a beneficial effect on the quality of life of patients with a documented history of PLE
Time frame: 18 months
To determine if there are other factors that may influence the severity of PLE symptoms eg. sun exposure and use of sun protection methods
Time frame: 18 months
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Clinuvel Pharmaceuticals Limited