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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinuvel Pharmaceuticals Limited
• Treatments: Afamelanotide; alpha-MSH

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.