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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 10, 2007
First Posted Date May 14, 2007
Last Update Posted Date October 5, 2011
Study Start Date May 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2011)
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 ]
Original Primary Outcome Measures
 (submitted: May 10, 2007)
  • 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 ]
Change History
Current Secondary Outcome Measures
 (submitted: February 25, 2009)
  • 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 Measures
 (submitted: May 10, 2007)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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).
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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with moderate/severe polymorphic light eruption (PLE)
Condition Polymorphic Light Eruption (PLE)
Intervention Drug: Afamelanotide (CUV1647)
16mg implant
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 4, 2011)
18
Original Estimated Enrollment
 (submitted: May 10, 2007)
150
Actual Study Completion Date September 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Austria,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00472901
Other Study ID Numbers CUV015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Clinuvel Pharmaceuticals Limited
Original Responsible Party Not Provided
Current Study Sponsor Clinuvel Pharmaceuticals Limited
Original Study Sponsor Same as current
Collaborators Not Provided
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
PRS Account Clinuvel Pharmaceuticals Limited
Verification Date October 2011