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

NCT ID: NCT00472901

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-09-30

Brief Summary

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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

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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

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Polymorphic Light Eruption (PLE)

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Afamelanotide (CUV1647)

16mg implant

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinuvel Pharmaceuticals Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lesley Rhodes, MD

Role: PRINCIPAL_INVESTIGATOR

Hope Hospital, Manchester, United Kingdom

Herbert Hoenigsmann, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Chris Baker, MD

Role: PRINCIPAL_INVESTIGATOR

St. Vincent's Hospital, Melbourne, AUSTRALIA

Locations

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St Vincents Hospital

Melbourne, , Australia

Site Status

Medical University of Vienna

Vienna, , Austria

Site Status

Hope Hospital

Manchester, , United Kingdom

Site Status

Countries

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Australia Austria United Kingdom

Other Identifiers

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CUV015

Identifier Type: -

Identifier Source: org_study_id