Stable non-segmental vitiligo Skin and Connective Tissue Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. A confirmed diagnosis of stable non-segmental vitiligo, defined as the absence of new lesions or enlargement of existing lesions for at least six months before enrolment 2. Not receiving topical or systemic treatment for vitiligo during the preceding six months and did not receive any additional therapies throughout the study period
Exclusion criteria
Exclusion criteria: 1. Malignancies 2. Severe systemic comorbidities 3. Acute infections 4. Pregnancy 5. Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response measured using the Total Vitiligo Area Scoring Index (VASI) and Body Surface Area (BSA) at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum IL-15 and IL-17 concentration measured using enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL at baseline, 3 and 6 months;Tissue-resident memory (TRM) and regulatory T (Treg) associated tissue marker levels, including expression of CD25, CD69, CD49a, CD103, and FOXP3, measured using double immunofluorescence and quantified using ImageJ software as the percentage of positively stained area at baseline, 3 and 6 months;Melanocyte-associated tissue markers levels, including the expression of MITF and c- KIT, measured using assessed by double immunofluorescence and quantified using ImageJ software as the percentage of positively stained area at baseline, 3 and 6 months | — |
Countries
Poland