Vitiligo
Conditions
Interventions
This is a randomized, comparative clinical study with an intrapatient design. Patients with a clinical diagnosis of vitiligo, aged 14 years or older, with stable and symmetrical lesions will be select
Sponsors
Universidade Federal do Rio Grande do Sul
Hospital de Clínicas de Porto Alegre
Eligibility
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with a clinical diagnosis of vitiligo, aged 14 years or older; Lesions stable for at least 12 months; Presence of symmetrical lesions in areas suitable for treatment; Availability to undergo narrowband ultraviolet B phototherapy sessions; Signed Informed Consent Form (ICF) and Image Use Authorization Form
Exclusion criteria
Exclusion criteria: Patients younger than 14 years of age; Patients who cannot undergo NB-UVB phototherapy for any reason; Unstable lesions or presence of Koebner phenomenon, confetti-like lesions, or trichrome lesions; Individuals with immunodeficiency, viral or bacterial infection, uncontrolled diabetes mellitus, blood dyscrasias, pregnant or breastfeeding women, or those who have used immunosuppressive medications within the past 30 days; Patients who have undergone phototherapy treatment within the past two months; History of photosensitivity or current use of photosensitizing medications within 30 days prior to initiating phototherapy; History of keloids, hypertrophic scarring, or tendency toward post-inflammatory hyperpigmentation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to assess repigmentation of vitiligo lesions treated with the two surgical techniques (epidermal grafting from suction blisters and grafting of noncultured autologous epidermal cell suspension prepared from blisters), verified through objective measurement of the treated achromic areas at baseline (T0) and at weeks 14 (T14) and 24 (T24), using lesion tracing on transparent millimetric grid sheets and standardized photographic documentation, based on the observation of a percentage reduction in achromic area over the follow-up period, allowing comparison of repigmentation outcomes between the two surgical techniques | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to compare the speed of repigmentation and the quality of pigmentation achieved with the two surgical techniques used in the treatment of vitiligo, verified through serial clinical evaluation of the treated areas with standardized photographic documentation and measurement of the repigmented area at T0, T14, and T24, based on analysis of the time to onset of repigmentation (in weeks) and the characteristics of the pigmentation pattern observed with each technique | — |
Countries
Brazil
Contacts
Public ContactFernanda Peres
Universidade Federal do Rio Grande do Sul
Outcome results
None listed