Overview
The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.
Eligibility
Inclusion Criteria:
- Male or female patient with a molecular-genetically confirmed diagnosis of XP-C or XP-V;
- Aged 18-75 years.
Exclusion Criteria:
- Known allergy to afamelanotide or the polymer contained in the implant;
- Presence of severe hepatic disease or hepatic impairment;
- Renal impairment;
- Any other medical condition which may interfere with the study protocol;
- Existing melanoma;
- Female who is pregnant or lactating;
- Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures;
- Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures;
- Use of any other prior and concomitant therapy which may interfere with the objective of the study;
- Participation in a clinical trial for an investigational agent.