xeroderma pigmentosum
Conditions
Sponsors
CLINUVEL EUROPE LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patient with a molecular-genetically confirmed diagnosis of XPC. - Aged 18-75 years. - Providing written Informed Consent prior to the performance of any study-specific procedure. - Willing and able to comply with the conditions specified in the protocol and study procedures, in the opinion of the Investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: - Known allergy to afamelanotide or the polymer contained in the implant or to lignocaine/ lidocaine or other local anaesthetic to be used during the administration of the implant, if applicable. - Presence of severe hepatic disease. - Hepatic impairment. - Renal impairment. - Any other medical condition which may interfere with the study protocol. - Existing melanoma - Female who is pregnant (confirmed by positive urine ß-HCG pregnancy test) or lactating. - Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) or a lifestyle excluding pregnancy, for up to three months after the last implant administration. - Sexually active man with a partner of child-bearing potential (premenopausal, not surgically sterile) who is not using adequate contraceptive measures, as described above. - Use of any other prior and concomitant therapy which may interfere with the objective of the study, within 30 days prior to the Screening visit. - Participation in a clinical trial for an investigational agent within 30 days prior to the Screening visit. - Not suitable for trial participation in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the impact of afamelanotide on UV-induced DNA damage and repair capacity in patients with XP;Secondary Objective: • Evaluate the safety and tolerability of afamelanotide in patients with XP • Evaluate the impact of afamelanotide on the skin disease severity of patients with XP • Evaluate the impact of afamelanotide on the skin melanin density of patients with XP • Evaluate the impact of afamelanotide on the quality of life of patients with XP;Primary end point(s): • The changes in UV-induced DNA damage and repair capacity from baseline Day 0 to Day 43 or Premature Termination Visit (if applicable), as measured through analysis of UV photoproducts and DNA repair mechanisms on exposed skin in comparison with non-exposed skin (refer to the biopsy protocol for details).;Timepoint(s) of evaluation of this end point: Day 0 to Day 43 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Day 0 to Day 43;Timepoint(s) of evaluation of this end point: Day 0 to Day 43 | — |
Countries
Germany
Contacts
Public ContactClinical Operations Manager Pilar B
CLINUVEL EUROPE LIMITED
Outcome results
None listed