A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum C and V (XPC and XPV)
Status: Unknown
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female patient with a molecular-genetically confirmed diagnosis of XP-C or XP-V;
• Aged 18-75 years.
Locations
Other Locations
Belgium
CLINUVEL Investigational site
RECRUITING
Clinuvel Investigational Site
Spain
CLINUVEL Investigational site
RECRUITING
Clinuvel Investigational Site
Contact Information
Primary
Head of Clinical Operations
mail@clinuvel.com
+441372860765
Time Frame
Start Date: 2022-03-28
Completion Date: 2024-12
Participants
Target number of participants: 6
Treatments
Experimental: Afamelanotide
Related Therapeutic Areas
Sponsors
Leads: Clinuvel Europe Limited