Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT05370235
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05370235
Study Brief:
Protocol Section:
NCT05370235