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

Polymorphic Light Eruption (PLE) Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472901
• Other study ID #: CUV015
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2007
• Last updated: October 4, 2011
• Start date: May 2007
• Est. completion date: September 2010

Study information

• Verified date: October 2011
• Source: Clinuvel Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Austrian Federal Agency for Safety in Healthcare AGES/PharmMed
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 ß-HCG pregnancy test prior to baseline) or lactating.

• Females of child-bearing potential that are not using adequate contraceptive measures.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Dermatitis, Contact
• Exanthema
• Polymorphic Light Eruption (PLE)

Intervention

Drug:
• Afamelanotide (CUV1647)
16mg implant

Locations

Country	Name	City	State
Australia	St Vincents Hospital	Melbourne
Austria	Medical University of Vienna	Vienna
United Kingdom	Hope Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Clinuvel Pharmaceuticals Limited

Countries where clinical trial is conducted

Australia,  Austria,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE		18 months	No
Secondary	To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting		18 months	No
Secondary	To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance		18 months	No
Secondary	To evaluate whether afamelanotide (CUV1647) has a beneficial effect on the quality of life of patients with a documented history of PLE		18 months	No
Secondary	To determine if there are other factors that may influence the severity of PLE symptoms eg. sun exposure and use of sun protection methods		18 months	No