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

- Drug: Afamelanotide (CUV1647)
16mg implant
- 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 ]
- 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 ]

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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 |
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.

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
Australia | |
St Vincents Hospital | |
Melbourne, Australia | |
Austria | |
Medical University of Vienna | |
Vienna, Austria, A1090 | |
United Kingdom | |
Hope Hospital | |
Manchester, United Kingdom |
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 |
Responsible Party: | Clinuvel Pharmaceuticals Limited |
ClinicalTrials.gov Identifier: | NCT00472901 |
Other Study ID Numbers: |
CUV015 |
First Posted: | May 14, 2007 Key Record Dates |
Last Update Posted: | October 5, 2011 |
Last Verified: | October 2011 |
Polymorphic Light Eruption (PLE) Afamelanotide CUV1647 photoprotection sun poisoning |
Exanthema Dermatitis, Contact Skin Diseases Dermatitis |
Skin Diseases, Eczematous Afamelanotide Dermatologic Agents |