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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy | Active Comparator | 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. |
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| Non-cultured epidermal cell suspension Surgery Alone | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-cultured epidermal cell suspension (NCES) surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of perilesional halo | • Comparing the incidence of perilesional halo after 4 months of treatment with NCES with and without OMP. | 4 months |
| Percent change in VESTA score | Comparing percent change in pigmentation as per VESTA score with and without OMP. | 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 | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing physician global assessment between two groups | Comparing physician global assessment after 4 months of treatment with NCES with and without OMP. | 4 months |
| Assessing tolerability and safety of oral mini-pulse |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology out patient clinic, Faculty of Medicine, Cairo University | Cairo | 11562 | Egypt |
Data will be available from the corresponding author upon justified request
3 months up to 12 months after publication.
Researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal.
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| Oral mini pulse | Drug | 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. |
|
| Excimer Sessions | Device | Patients will start Excimer sessions 2 times per week for 4 months after complete healing. |
|
Assessing tolerability and safety of oral mini-pulse therapy along with NCES by assessing rate of infection and delayed healing.
| 4 months |
| Assessing change in visual analogue scale | Assessing patient satisfaction with and without OMP using change in visual analogue scale. | 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. | 4 months |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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