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Assessing the additive value of mini-oral pulse steroid therapy in surgical treatment of acral and difficult to treat sites of vitiligo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period | Active Comparator | this group will receive oral mini-pulse steroids (low-dose dexamethasone: 5mg/week on 2 successive days per week) for 2 weeks prior to NCES and for 4 weeks afterwards |
|
| Vitiligo surgery without mini-oral pulse steroid therapy | Active Comparator | this group will undergo None cultured epidermal suspension (NCES) without oral mini-pulse steroids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral steroid-dexamethasone | Drug | this study is the first according to the best of our knowledge assessing the value of adding mini oral pulse steroid therapy to non cultured epidermal suspension in treatment of stable acral and difficult to treat vitiligo |
| Measure | Description | Time Frame |
|---|---|---|
| comparing percent change in pigmentation in both arms | • Comparing percent change of pigmentation as per VESTA score after 3 months of treatment with NCES with and without mini oral pulse steroids. | 3 months |
| comparing percent change in surface area in both arms | • Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| comparing physician global assessment in both arms | • Comparing physician global assessment after treatment with NCES with and without oral mini-pulse therapy | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mogawer, MD, PhD | Contact | +20106815330 | raniamogawer@kasralainy.edu.eg | |
| Prof. Nanis Ragab, MD, PhD | Contact | +201227449161 | nanisragab@kasralainy.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Mogawer, MD, PhD | Dermatology Department, Cairo University Hopsitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Department, Cairo University Hospitals | Giza | 12655 | Egypt |
Participants' data that underlie reported results will be shared upon request, after deidentification
within 3 months and for 12 months after completion of the study
Controlled Access:
Researchers who provide a methodologically sound proposal will be allowed to access data to achieve aims in the approved proposal
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| non cultured epidermal suspension | Procedure | this is the best surgical technique for surgical treatment of vitiligo that would be done for both arms |
|
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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