Skin and Connective Tissue Diseases
Conditions
Interventions
topical and subcutaneous
topical through rays
Sponsors
CLINUVEL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female participants with a confirmed diagnosis of generalized vitiligo in the face and body with T-VASI=0.3 (excluding hands and feet) and F-VASI=0.3 (face does not include scalp, ears, neck or lips) -Stable or active vitiligo diagnosed for at least three months -Aged 12 or more -Fitzpatrick skin types IV-VI -Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator -Providing written Informed Consent prior to the performance of any study-specific procedure
Exclusion criteria
Exclusion criteria: -Fitzpatrick skin types I-III -Extensive leukotrichia within the vitiligo lesion (over 33%) -Treatment with NB-UVB phototherapy in the last three months prior to phototherapy. A three-month washout period from phototherapy is necessary prior to commencing treatment -Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/ lidocaine or other local anesthetic if used during the administration of the implant -Any other treatment for vitiligo within four weeks prior to the Screening Visit including JAK inhibitors -History of melanoma or lentigo malignacy -History of dysplastic nevus syndrome -Any malignant skin lesions -Any skin disease that may interfere with the study evaluation -Presence of severe hepatic disease or hepatic impairment -Female who is pregnant (confirmed by positive ß-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 (three months) and for a period of three months thereafter – except if abstinence from intercourse is practiced -Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who is not using adequate contraceptive measures, as described above -Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit -Use of any prior and concomitant therapy which may interfere with the objective of the study, including drugs that cause photosensitivity or skin pigmentation within 60 days prior to the Screening Visit -Participants assessed as not suitable for the study in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving T-VASI50 (excluding hands and feet) on Day 140 in those treated with SCENESSE® and NB-UVB compared to NB-UVB alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Repigmentation and safety analysis | — |
Countries
Kenya
Contacts
Public ContactGenevieve Tay
Communications Associate
Outcome results
None listed