Clinical trial NCT00472901: Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)
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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polymorphic Light Eruption (PLE)
Keywords: Polymorphic Light Eruption (PLE)
Afamelanotide
CUV1647
photoprotection
sun poisoning
Lead sponsor: Clinuvel Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2007-05-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate/severe polymorphic light eruption (PLE)

Brief 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.

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 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.

Primary outcomes:
measure: To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE
timeFrame: 18 months
Secondary outcomes:
measure: To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting
timeFrame: 18 months
measure: To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance
timeFrame: 18 months
measure: To evaluate whether afamelanotide (CUV1647) has a beneficial effect on the quality of life of patients with a documented history of PLE
timeFrame: 18 months
measure: To determine if there are other factors that may influence the severity of PLE symptoms eg. sun exposure and use of sun protection methods
timeFrame: 18 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St Vincents Hospital
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Manchester
country: United Kingdom
facility: Hope Hospital
Study officials:
affiliation: Hope Hospital, Manchester, United Kingdom
name: Lesley Rhodes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Herbert Hoenigsmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Vincent's Hospital, Melbourne, AUSTRALIA
name: Chris Baker, MD
role: PRINCIPAL_INVESTIGATOR
References: