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

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)	Phase 3


Study Type:	Observational
Study Design:	Time Perspective: Prospective
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting [ Time Frame: 18 months ] [ Designated as safety issue: No ]
To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Enrollment:	18
Study Start Date:	May 2007
Study Completion Date:	September 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

16mg implant

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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with moderate/severe polymorphic light eruption (PLE)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Clinuvel Pharmaceuticals Limited
ClinicalTrials.gov Identifier:	NCT00472901 History of Changes
Other Study ID Numbers:	CUV015
Study First Received:	May 10, 2007
Last Updated:	October 4, 2011
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

Additional relevant MeSH terms:


Exanthema Dermatitis, Contact Skin Diseases Dermatitis Skin Diseases, Eczematous	Alpha-MSH Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016