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Since abnormal keratinocyte (KC) proliferation and differentiation as well as defective E cadherin expression were reported in vitiligo lesions, the investigators set to study the potential efficacy of combining Retinoids, which are known to improve KC proliferation and differentiation and increase the expression of adhesion molecules, with narrowband UVB in the treatment of vitiligo.
• Twenty patients with generalized vitiligo will be included in this study.
All patients will be subjected to:
Laboratory evaluation:
Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NbUVB | Other | Group A: patients will receive three NB-UVB sessions per week for 48 sessions. |
|
| Combined nbUVB and Acitretin | Experimental | Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acitretin | Drug | The patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index | The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Area Scoring Index (VASI) | 4-5 months |
| Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Disease Activity Score. | The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Disease Activity Score (VIDA). | 4-5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noha A. Saleh, M.Sc | Contact | +201222177210 | noushy2938@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 11956 | Egypt |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D003863 | Depression |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017255 | Acitretin |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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Two groups Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3 mg/kg/day daily.
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| Narrow band ultraviolet B | Other | Patients receive nbUVB session 3 times per week |
|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D004066 | Digestive System Diseases |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |