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

NCT00472901 | Completed

• 1 other identifier: CUV015
• Study Type: observational
• Target: 18
• Locations: 2 countries
• Sites: 2

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.

Conditions

Polymorphic Light Eruption (PLE)

Keywords

Polymorphic Light Eruption (PLE); Afamelanotide; CUV1647; photoprotection; sun poisoning

Outcome Measures

Primary Outcomes (1)

• To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE

  18 months

Secondary Outcomes (4)

• To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting

  18 months

• To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance

  18 months

• To evaluate whether afamelanotide (CUV1647) has a beneficial effect on the quality of life of patients with a documented history of PLE

  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

  18 months

Interventions

Afamelanotide (CUV1647) DRUG

16mg implant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate/severe polymorphic light eruption (PLE)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinuvel Pharmaceuticals Limited: lead

Study Sites (3)

St Vincents Hospital

Melbourne, Australia

Location

Medical University of Vienna

Vienna, A1090, Austria

Location

Hope Hospital

Manchester, United Kingdom

Location

MeSH Terms

Interventions

afamelanotide

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 14, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2010
• Last Updated: October 5, 2011

Record last verified: 2011-10

Locations

AU (1); GB (1)