A Phase 4 interventional study of Non-cultured epidermal cell suspension (NCES) surgery and Oral mini pulse in Vitiligo, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
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:
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:
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 60 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive low-dose oral mini-pulse dexamethasone (5 mg/week given on two consecutive days) for 4 weeks before and 4 weeks after undergoing non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to assess repigmentation, development of perilesional halo, and treatment safety.
Procedure: Non-cultured epidermal cell suspension (NCES) surgery · Drug: Oral mini pulse · Device: Excimer Sessions
Participants will undergo non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions without oral mini-pulse steroid therapy. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to evaluate repigmentation outcomes and development of perilesional halo.
Procedure: Non-cultured epidermal cell suspension (NCES) surgery · Device: Excimer Sessions
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.
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.
Patients will start Excimer sessions 2 times per week for 4 months after complete healing.
Incidence of perilesional halo
• Comparing the incidence of perilesional halo after 4 months of treatment with NCES with and without OMP.
Time frame: 4 months
Percent change in VESTA score
Comparing percent change in pigmentation as per VESTA score with and without OMP.
Time frame: 4 months
Percent change in the surface area of the depigmented patch using point counting technique
Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique with and without OMP
Time frame: 4 months
Comparing physician global assessment between two groups
Comparing physician global assessment after 4 months of treatment with NCES with and without OMP.
Time frame: 4 months
Assessing tolerability and safety of oral mini-pulse
Assessing tolerability and safety of oral mini-pulse therapy along with NCES by assessing rate of infection and delayed healing.
Time frame: 4 months
Assessing change in visual analogue scale
Assessing patient satisfaction with and without OMP using change in visual analogue scale.
Time frame: 4 months
Compare VESTA percentage change in different body sites and age groups
Assessing response to NCES in different sites of body and different age groups and the duration needed for pigmentation to occur.
Time frame: 4 months
Plan to share: Yes — Data will be available from the corresponding author upon justified request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 3 months up to 12 months after publication.
Access criteria: Researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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