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

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ClinicalTrials.gov Identifier: NCT00472901
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : October 5, 2011
Sponsor:
Information provided by (Responsible Party):
Clinuvel Pharmaceuticals Limited

Study Description
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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.

Condition or disease Intervention/treatment
Polymorphic Light Eruption (PLE) Drug: Afamelanotide (CUV1647)

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.

Study Design
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Study Type : Observational
Actual Enrollment : 18 participants
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).
Study Start Date : May 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Groups and Cohorts
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Intervention Details:
  • Drug: Afamelanotide (CUV1647)
    16mg implant

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting [ Time Frame: 18 months ]
  2. To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance [ Time Frame: 18 months ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Clinuvel Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00472901     History of Changes
Other Study ID Numbers: CUV015
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011

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