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| Name | Class |
|---|---|
| Cairo University | OTHER |
| Menia University | UNKNOWN |
| Suez Canal University | OTHER |
| Assiut University |
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Vitiligo is a disease in which autoimmunity plays a major role. Multiple treatment options are available, of which narrow-band UVB is a cornerstone, acting through immunosuppression and repigmentation by stimulating reservoir melanocytes.
It's expected that this immunsupression is lower in darker skin types, where increased basal melanin might act as a barrier.
Vitiligo is acquired depigmentation disorder. Several theories were hypothesized for causing vitiligo, of which the autoimmune theory is the most accepted.
The main targets of therapy are stabilization of the disease activity through immunosuppression, and repigmentation through stimulation of reservoir melanocytes proliferation and migration.
Narrow band ultraviolet phototherapy (NB-UVB) remains the cornerstone treatment of vitiligo. NB-UVB can induce both immunosuppression and repigmentation. Several factors can modulate the efficacy of NB-UVB therapy in treatment of vitiligo cases, including patient's age, lesion site, duration of the disease, and duration of the therapy.
The immunosuppressive function of NB-UVB was first detected in 1963 by Hanisko and Suskind, who observed that the contact hypersensitivity response in skin sensitized to dinitrochlorobenzene (DNCB) was reduced if skin was previously exposed to suberythemal doses of UVB.
Present evidence suggests that UVB suppress immune system through generation of T-suppressor cells, which inhibit the effector cells of Th1 type. It appears that UV-induced immunosuppression depresses the function of Th1 cells and enhances the activity of Th2 cells via cytokines such as Interleukin 10.
It's expected that this immunsupression is lower in darker skin types, where increased basal melanin might act as a barrier. However, skin was previously divided to UVB-resistant and UVB-sensitive (UVB-R and UVB-S) based on the contact hypersensitivity testing, regardless of the skin type. Moreover, A study on NB-UVB phototherapy for psoriasis revealed that photoadaptation during NB-UVB therapy Is Independent of skin type.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | 50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments. |
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| Placebo | Placebo Comparator | 50 patients will receive placebo having the same color, form and packaging as the dexamethasone therapy for 6 months plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral dexamethasone minipulse | Drug | 50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments. |
| Measure | Description | Time Frame |
|---|---|---|
| Detecting number of participants with clinical activity of vitiligo | Appearance of new lesions or expansion of pre-existing lesions by clinical examination. | At 6 months after treatment. |
| Photography to detect activity of vitiligo | New lesions in each area will be counted. | Change from baseline (first visit) at 6 months after treatment. |
| Elevation of serum Vitiligo activity markers. | A 5 cc blood sample will be withdrawn from each patient for: ELISA assessment of CXCL-10 (Pg/ml) | Change from baseline at 6 months after treatment. |
| Elevation of PCR levels of serum Vitiligo activity markers | A 5 cc blood sample will be withdrawn from each patient for: PCR assessment of m-RNA of CXCL-10 as markers of disease activity. | Change from baseline at 6 months after treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahy ElBassiouny, Ass.Lecturer | Contact | 002 01002202651 | mahyelbasyouni@gmail.com | |
| Marwa Abdallah, Professor | Contact | 002 01001166299 | marwa_abdallah@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mahy ElBassiouny, Ass.Lecturer | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | Abbaseya | 00202 | Egypt |
Methodology and outcome of the study is palnned to be published in an international medical journal with sharing participants data.
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| OTHER |
| Alexandria University | OTHER |
100 patients with non-segmental vitiligo are randomized to either NB-UVB therapy with placebo versus NB-UVB combined with mini-oral pulse steroids therapy. Vitligo activity will be assessed according to the VIDA scoring system. Skin type, extent of vitiligo using VES score, photography of all areas according to the VES areas at a fixed distance of 50 cm from the patient, and using a 1 cm diameter circular white sticker for reference later will be done. All patients will receive NB-UVB phototherapy at starting dose of 0.3 J/cm2, 3 times per week for 6 months (72 sessions) with gradually increasing increments according until faint erythema is attained at which point the dose is fixed. 100 patients will be randomized into 2 groups; 50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week while the other 50 patients will receive placebo having the same color, form and packaging for 6 months.
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Masking involves only oral therapy; 100 patients will be randomized into 2 groups; 50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week while the other 50 patients will receive placebo having the same color, form and packaging for 6 months.
The investigators are blinded.
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| Placebo oral tablet | Drug | 50 patients will receive placebo having the same color, form and packaging as the dexamethasone therapy for 6 months plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments |
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