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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT04525157
Eligibility Criteria:
Inclusion Criteria:
* for double-blind phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 15% to 50% of total body surface involvement
* for open label phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 10% to 50% of total body surface involvement
* Vitiligo involving the head and neck
* Stable or slowly progressive vitiligo over a 3-month period
* Aged 21 years or more
* Willing and able to comply with the conditions specified in this protocol and study procedures, in the opinion of the Investigator
* Provided written Informed Consent prior to the performance of any study-specific procedure
Exclusion Criteria:
* Extensive leukotrichia, in the opinion of the Investigator
* Previous treatment with NB-UVB light or other light source within 6 weeks prior to the Screening Visit
* Patient not responsive to previous NB-UVB light treatment, defined as a patient who had undergone at least 20 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator
* Previous topical treatment for vitiligo, including topical immunomodulators (e.g. corticosteroids, calcineurin inhibitors), within 4 weeks prior to the Screening Visit
* 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
* History of photosensitivity disorders
* Claustrophobia
* Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator
* Any current skin disease that may have interfered with the study evaluation
* Female who was pregnant (confirmed by positive β-human chorionic gonadotropin (HCG) pregnancy test) or lactating
* Female of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives or diaphragm plus spermicide or intrauterine device) during the treatment phase (7 months) and for a period of three months thereafter - except if abstinence from intercourse was practiced
* Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who was not using adequate contraceptive measures, as described above
* Participated in a clinical trial for an investigational agent within 30 days prior to the Screening Visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04525157
Study Brief:
Protocol Section:
NCT04525157