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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

  • To evaluate whether CUV1647 prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE [ Time Frame: 18 months ]
  • To evaluate the effect of CUV1647 on the use of rescue medications (i.e. corticosteroids, anti-inflammatory drugs) [ Time Frame: 18 months ]


    • Current Secondary Outcome:

    • To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting [ Time Frame: 18 months ]
    • To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance [ Time Frame: 18 months ]
    • 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 ]
    • 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 ]


    Original Secondary Outcome:

    • To evaluate the safety and tolerability of CUV1647 in this specific clinical setting [ Time Frame: 18 months ]
    • To evaluate the effect of CUV1647 on melanin density levels as measured by skin reflectance [ Time Frame: 18 months ]
    • To evaluate whether CUV1647 has a beneficial effect on the quality of life of patients with a documented history of PLE [ Time Frame: 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 [ Time Frame: 18 months ]


    Information By: Clinuvel Pharmaceuticals Limited

    Dates:
    Date Received: May 10, 2007
    Date Started: May 2007
    Date Completion:
    Last Updated: October 4, 2011
    Last Verified: October 2011