Clinical trial

Plexin B2 Gene Expression and Polymorphisms in Psoriasis : Relation to NB-UVB, Acitretin and Combined Therapy

Name
Ebtehal Mohamed
Description
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.
Trial arms
Trial start
2021-09-01
Estimated PCD
2023-01-30
Trial end
2023-03-30
Status
Completed
Phase
Early phase I
Treatment
Narrow band Ultraviolet B phototherapy group
3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
Arms:
Narrow band Ultraviolet B phototherapy group
Other names:
NB-UVB
Acitretin group
dose of 0.5-1 mg per kg per day orally for 3 month.
Arms:
Acitretin group
Acitretin 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.
Arms:
Acitretin plus Narrow band Ultraviolet B phototherapy group
Size
200
Primary endpoint
Improve the prognosis of patients with psoriasis Vulgaris
3 month
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}
Updated at
2023-09-21

1 organization

2 products

1 indication

Product
Acitretin