Psoriasis Vulgaris
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONNarrow band Ultraviolet B phototherapy group
3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
DRUGAcitretin group
dose of 0.5-1 mg per kg per day orally for 3 month.
COMBINATION_PRODUCTAcitretin plus Narrow band Ultraviolet B phototherapy group
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.
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
24 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients of both sexes. Diagnosed clinically with moderate to severe Psoriasis Vulgaris. * patients able to swallow tablet and receive Narrow band Ultraviolet B phototherapy without any contraindication
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improve the prognosis of patients with psoriasis Vulgaris | 3 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improve the clinical out comes of patients with psoriasis Vulgaris | 12 month | 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 |
Countries
Egypt
Outcome results
None listed