Vitiligo
Conditions
Keywords
non-cultured epidermal cell suspension, Vitiligo, Segmental, non-acral, Mini-oral pulse steroid, peri-lesional halo
Brief summary
The goal of this clinical trial is to learn if adding mini-oral pulse steroid therapy improves the results of non-cultured epidermal cell suspension (NCES) surgery in patients with stable vitiligo. It will also evaluate the safety of this treatment approach. The main questions it aims to answer are: * Does adding mini-oral pulse steroid therapy reduce the development of a perilesional halo after NCES surgery? * Does the addition of steroids improve the degree of repigmentation and overall treatment outcomes in vitiligo lesions? Researchers will compare NCES surgery with mini-oral pulse steroids to NCES surgery alone to determine whether the steroid therapy improves surgical outcomes. Participants will: * Undergo NCES vitiligo surgery for stable segmental or non-acral vitiligo lesions. * Be randomly assigned to receive either surgery alone or surgery plus low-dose oral mini-pulse dexamethasone therapy. * Attend follow-up visits and clinical assessments for approximately 4 months. * Receive excimer laser sessions twice weekly after healing and have standardized photographs and scoring assessments to evaluate repigmentation.
Interventions
PROCEDURENon-cultured epidermal cell suspension (NCES) surgery
Under aseptic precautions and local anesthesia, a Thiersch graft with a donor-to-recipient ratio of 1:3 will be harvested from the donor site (usually upper thigh/ buttocks). The skin graft will be transferred to trypsin-EDTA solution and incubated at 37 °C for 20-30 minutes to separate epidermis from the dermis, and then washed with lactated Ringer. The tissue will be teased gently with sterile forceps to release epidermal cells from the trypsin-digested graft. The white dermis will be removed, and the suspension will be centrifuged at 1000g for 5-10 minutes, and the supernatant will be discarded.
DRUGOral mini pulse
Oral mini-pulse steroids (low-dose dexamethasone: 5mg/week on 2 successive days per week) for 4 weeks before NCES and for 4 weeks afterward.
DEVICEExcimer Sessions
Patients will start Excimer sessions 2 times per week for 4 months after complete healing.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with segmental vitiligo lesions that are not responsive to conventional treatment. * Patients with non-Acral vitiligo lesions that are not responsive to conventional treatment and on sites known to be responsive to surgery, like the face and trunk. * Stability for ≥ 1 year. * Age ≥12 years. * Lack of systemic and topical treatment for at least 3 months prior inclusion in the study.
Exclusion criteria
* Acral vitiligo. * Segmental vitiligo lesions that are responsive to conventional treatment. * Non acral vitiligo lesions on sites that are knowingly not responsive to surgery, like knees and elbows. * Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges, hypochromia, depigmentation of previously pigmented areas or koebnerization in \< 1 year. * Age \< 12 years. * Pregnant females. * Patients with contraindication to systemic steroid like uncontrolled hypertension, diabetes or tuberculosis * Systemic and topical treatment in the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of perilesional halo | 4 months | • Comparing the incidence of perilesional halo after 4 months of treatment with NCES with and without OMP. |
| Percent change in VESTA score | 4 months | Comparing percent change in pigmentation as per VESTA score with and without OMP. |
| Percent change in the surface area of the depigmented patch using point counting technique | 4 months | Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique with and without OMP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing physician global assessment between two groups | 4 months | Comparing physician global assessment after 4 months of treatment with NCES with and without OMP. |
| Assessing tolerability and safety of oral mini-pulse | 4 months | Assessing tolerability and safety of oral mini-pulse therapy along with NCES by assessing rate of infection and delayed healing. |
| Assessing change in visual analogue scale | 4 months | Assessing patient satisfaction with and without OMP using change in visual analogue scale. |
| Compare VESTA percentage change in different body sites and age groups | 4 months | Assessing response to NCES in different sites of body and different age groups and the duration needed for pigmentation to occur. |
Countries
Egypt
Outcome results
None listed