Vitiligo
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with non-segmental vitiligo commencing standard of care treatment, consisting of a potent topical corticosteroid, such as FP cream, alone or in combination with NB-UVB phototherapy for at least 6 months. - Patients with new lesions and/or signs of disease progression (active disease) within the past 6 months prior to Screening. - Males and females aged *18 - Patients able to communicate well with the investigator, to understand the requirements of the study, as well as understand and sign the written informed consent.
Exclusion criteria
Exclusion criteria: - Patients that have received phototherapy or systemic immunosuppressive treatment during the last 6 weeks prior to Screening. - Patients that have received topical anti-inflammatory treatment (topical corticosteroids, calcineurin inhibitors) during the last 4 weeks prior to Screening. - Patients currently receiving treatments other than potent topical corticosteroids, such as FP 0.05% cream, calcineurin inhibitors (tacrolimus, pimecrolimus) or NB-UVB phototherapy for non-segmental vitiligo. - Recurrent HSV skin infections. - Patients with a history of hypertrophic scars or keloid. - Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anaesthesia. - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (unless female is confirmed post-menopausal). - Patients with haemophilia or other clotting disorders - Patients previously diagnosed with depression according to the DSM5 by a qualifying physician. - Patients without lesions located at suitable areas for biopsies / suction blisters sampling (e.g. the face)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical non-invasive parameters Surface area of depigmented skin will be assessed at Baseline, and after 3 months and 6 months of treatment from a target lesion (copy sheet method) and from the total body (VES score and VASI score) to determine the extent of the disease. 2. Laboratory parameters -Biomarkers will be assessed from blood, suction blister fluid and punch biopsies at Baseline and after 3 months of treatment. 3. Imaging -Confocal reflectance microscopy imaging will be used for non-invasive imaging of melanocytes and inflammatory cells in vitiligo. -Digital imaging of the target lesion. 4. Patient Reported Outcomes (PROs) -The DLQI questionnaire will be used to collect Quality of Life data at Baseline, 3 months and 6 months after treatment. -The PHQ-9 will be used to collect data on the impact of vitiligo on the presence and severity of depression. | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
Netherlands
Outcome results
None listed