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 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 CUV1647 can reduce the use of rescue medication in this group.

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

MedlinePlus related topics: Rashes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, 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).

Further study details as provided by Clinuvel Pharmaceuticals Limited:

Primary Outcome Measures:

To evaluate whether 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 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 CUV1647 in this specific clinical setting [ Time Frame: 18 months ]
To evaluate the effect of CUV1647 on melanin density levels as measured by skin reflectance [ Time Frame: 18 months ]
To evaluate whether 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 red 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.

This study primarily aims to evaluate CUV1647 in the prevention of PLE episodes and reduction of PLE symptoms; in addition looking at the reduction of rescue medication use in this group. The study also aims to evaluate the safety and tolerability of CUV1647 in this specific clinical setting.

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

Contacts

Contact: Rachelle Kirk-Burnnand, BSc

+613 9660 4900

rachelle.kirk-burnnand@clinuvel.com

Locations

United Kingdom
Hope Hospital	Recruiting
Manchester, United Kingdom

Sponsors and Collaborators

Clinuvel Pharmaceuticals Limited

Investigators

Principal Investigator:	Lesley Rhodes, MD	Hope Hospital, Manchester, United Kingdom
Principal Investigator:	Stan Pavel, MD, PhD	Leiden University Medical Centre, Leiden, Netherlands
Principal Investigator:	Errol Prens, MD	Erasmus Medical Centre, Rotterdam, Netherlands
Principal Investigator:	Herbert Hoenigsmann, MD	Medical University of Vienna

More Information

Study ID Numbers:	CUV015
Study First Received:	May 10, 2007
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00472901
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Clinuvel Pharmaceuticals Limited:

Polymorphic Light Eruption (PLE)
CUV1647
photoprotection
sun poisoning

Study placed in the following topic categories:

Exanthema
Skin Diseases
Poisoning

Skin Diseases, Eczematous
Dermatitis, Contact
Dermatitis

ClinicalTrials.gov processed this record on January 14, 2009