NCT00472901

Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)

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
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Clinuvel Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 and/or phototherapy.

Conditions

• Polymorphic Light Eruption (PLE)

Interventions

Type	Name	Description
DRUG	Afamelanotide (CUV1647)	16mg implant

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-12-01
• Completion: 2010-09-01
• First posted: 2007-05-14
• Last updated: 2011-10-05

Locations

3 sites across 3 countries: Australia, Austria, United Kingdom