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

NCT00472901 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2011-10-05

No results posted yet for this study

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)

Interventions

DRUG

Afamelanotide (CUV1647)

16mg implant

Sponsors & Collaborators

  • Clinuvel Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Lesley Rhodes, MD · Hope Hospital, Manchester, United Kingdom

  • Herbert Hoenigsmann, MD · Medical University of Vienna

  • Chris Baker, MD · St. Vincent's Hospital, Melbourne, AUSTRALIA

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-12-31
Completion
2010-09-30

Countries

  • Australia
  • Austria
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00472901 on ClinicalTrials.gov