Early clinical and biomarker responses after treatment in patients with non-segmental vitiligo

Completed

• Conditions: Vitiligo; 10035023

• Registration Number: NL-OMON48618
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

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

- 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)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified