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Patients will be randomly assigned (1:1:1 ) either to ; NB-UVB photo-therapy alone , Acitretin therapy alone or NB-UVB photo-therapy combined with Acitretin therapy randomization will be done by closed envelopes . investigator will be blinded to study drug assignment , while patients and data interpreter will not be masked to study drug assignment.
Study Setting: Qena University Hospital, Department of Dermatology ,Venereology& Andrology.
Study subjects: the study will include psoriasis Vulgaris patients who Come to the out patients dermatologic clinic and matching inclusion & exclusion criteria as follow, from 9/2021 up to 3/2023 and then patients will be divided to each group equally as follow:
Group 1: Patients will be treated with NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.
Group 2: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months Group 3: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
Group 4: 30 healthy individuals un related , age, sex , BMI matched with volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narrow band Ultraviolet B phototherapy group | Active Comparator | Patients will be treated with Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2. |
|
| Acitretin group | Active Comparator | Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months |
|
| Acitretin plus Narrow band Ultraviolet B phototherapy group | Active Comparator | Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2. |
|
| Control group | No Intervention | 30 healthy individuals un related , age, sex , BMI matched with volunteers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narrow band Ultraviolet B phototherapy group | Radiation | 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improve the prognosis of patients with psoriasis Vulgaris | detect the effect of Acitretin alone and Narrow band Ultraviolet B phototherapy alone versus combined therapy on genetic mutation and level of plexin b2 in patients with psoriasis Vulgaris | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Improve the clinical out comes of patients with psoriasis Vulgaris | detect the effect of Acitretin alone and Narrow band Ultraviolet B phototherapy alone versus combined therapy on clinical out comes and PASI score of patients with psoriasis Vulgaris | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy , lactation & women intent to become pregnant within 3 year after discontinuation of acitretin Patients with Hyperlipidemia Patients with mental problems and depression Patients with a history of malignancies, renal & liver diseases. Patients with a history of any inflammatory diseases as atopic dermatitis , asthma ulcerative colitis ) and Crohn's disease Patients received NB-UVB phototherapy in the last 6 months. Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.
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| Name | Affiliation | Role |
|---|---|---|
| Eisa Hegazy, Prof. | Faculty of Medicine, South Valley University, Egypt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine , South Valley University | Qina | Egypt |
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| ID | Term |
|---|---|
| D017255 | Acitretin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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|
| Acitretin group | Drug | dose of 0.5-1 mg per kg per day orally for 3 month. |
|
| Acitretin plus Narrow band Ultraviolet B phototherapy group | Combination Product | Acitretin in dose of 0.5-1 mg per kg per day orally plus Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2. |
|
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |