Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE) - Full Text View

Sponsored by:	Clinuvel Pharmaceuticals Limited
Information provided by:	Clinuvel Pharmaceuticals Limited
ClinicalTrials.gov Identifier:	NCT00472901

Purpose

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.

Condition	Intervention	Phase
Polymorphic Light Eruption (PLE)	Drug: Afamelanotide (CUV1647) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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).

Resource links provided by NLM:

MedlinePlus related topics: Rashes

U.S. FDA Resources

Further study details as provided by Clinuvel Pharmaceuticals Limited:

Primary Outcome Measures:

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 effect of afamelanotide (CUV1647) on the use of rescue medications (i.e. corticosteroids, anti-inflammatory drugs) [ Time Frame: 18 months ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	150
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2009

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472901

Locations

Australia
St Vincents Hospital
Melbourne, Australia
Austria
Medical University of Vienna
Vienna, Austria, A1090
United Kingdom
Hope Hospital
Manchester, United Kingdom

Sponsors and Collaborators

Clinuvel Pharmaceuticals Limited

Investigators

Principal Investigator:	Lesley Rhodes, MD	Hope Hospital, Manchester, United Kingdom
Principal Investigator:	Herbert Hoenigsmann, MD	Medical University of Vienna
Principal Investigator:	Chris Baker, MD	St Vincent's Hospital, Melbourne, Australia

More Information

No publications provided

Responsible Party:	Clinuvel Pharmaceuticals Limited ( Dr. Dennis Wright )
Study ID Numbers:	CUV015
Study First Received:	May 10, 2007
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00472901 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Austrian Federal Agency for Safety in Healthcare AGES/PharmMed

Keywords provided by Clinuvel Pharmaceuticals Limited:

Polymorphic Light Eruption (PLE)
Afamelanotide
CUV1647
photoprotection
sun poisoning

Study placed in the following topic categories:

Exanthema
Skin Diseases
Poisoning

Skin Diseases, Eczematous
Dermatitis, Contact
Dermatitis

Additional relevant MeSH terms:

Exanthema
Skin Diseases
Skin Diseases, Eczematous
Dermatitis, Contact
Dermatitis

ClinicalTrials.gov processed this record on July 02, 2009