Vitiligo
Conditions
Keywords
vitiligo, surgery, mini-oral pulse steroid therapy, resistant
Brief summary
Assessing the additive value of mini-oral pulse steroid therapy in surgical treatment of acral and difficult to treat sites of vitiligo
Interventions
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
PROCEDUREnon cultured epidermal suspension
this is the best surgical technique for surgical treatment of vitiligo that would be done for both arms
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with non-segmental vitiligo (NSV) with acral or resistant lesions over the elbows and knees, that has not responded to conventional treatment * Stability for ≥ 1 year * Age ≥18 years * Lack of topical treatment for at least 1 month prior to surgery and systemic treatment for at least 3 months prior to surgery.
Exclusion criteria
* Non acral NSV responsive to conventional treatment modalities * Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges or koebnerization in \< 1 year * Age \< 18 years. * Pregnant females. * Patients with hypertension, diabetes or tuberculosis * Topical treatment in the past month and systemic treatment in the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comparing percent change in pigmentation in both arms | 3 months | • Comparing percent change of pigmentation as per VESTA score after 3 months of treatment with NCES with and without mini oral pulse steroids. |
| comparing percent change in surface area in both arms | 3 months | • Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comparing physician global assessment in both arms | 3 months | • Comparing physician global assessment after treatment with NCES with and without oral mini-pulse therapy |
Countries
Egypt
Contacts
Primary ContactDr. Mogawer, MD, PhD
Backup ContactProf. Nanis Ragab, MD, PhD
Outcome results
None listed