Combined Oral Vitamin D and UVB Versus UVB Alone in Treatment of Psoriasis Vulgaris

NCT ID: NCT03874975

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-04-01

Brief Summary

To compare the results of vitamin D plus UVB in treatment of psoriasis vulgaris with the results of UVB alone to study the relation between serum vitamin D and PASI score before and after treatment.

Detailed Description

Psoriasis is a chronic immune-mediated inflammatory skin disease, with a prevalence of about 2%-3% in the general population. The primary manifestation of psoriasis most commonly manifests on the skin, although inflammatory processes can occur also in other organs .

Vitamin D, also known as the sunshine vitamin, has long been known to be a hormone that regulates calcium-phosphorous homeostasis and safeguards the integrity of the skeletal system . The epidermis is the natural source of vitamin D synthesis by the action of ultraviolet light (UV) B of the sun or other UVB source . On the other hand, evidence is accumulating that vitamin D might represent a key modulator of immune and inflammation mechanisms . Recently, a role for vitamin D in the pathogenesis of different skin diseases, including psoriasis, has been reported.

Psoriasis lesions are characterized by hyper-proliferation with incomplete differentiation of epidermal keratinocytes and decreased keratinocyte apoptosis, associated with inflammatory cellular infiltrate in both dermis and epidermis . Psoriasis Area and Severity Index (PASI) score is currently the preferred method for the assessment of the disease severity and extent .

Physiologically, the active form of vitamin D and its receptor regulate the differentiation and proliferation of keratinocytes, the balance of the cutaneous immune system and the process of apoptosis.

Several studies identified an association between polymorphisms of vitamin D receptor (VDR) and psoriasis susceptibility .The 1,25(OH)D has been shown to exert anti-proliferative effects on keratinocytes .

The exact mechanism of action of NBUVB is not known. It is proposed that it acts in the following ways: (1) Cellular DNA is converted to pyrimidine dimers which interfere with cell cycle progression, (2) alteration in cytokine production, NBUVB phototherapy as the second-line treatment for psoriasis, recommended when the topical therapy fails, is contraindicated or impractical. UVB radia- tions of wavelength 311 nm may result in the clearance of disease symptoms after just 5-8 weeks.

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

oral vitamin D

vitamin D and UVB versus UVB alone in psoriatic patients and evaluate patients by PASI score before and after treatment and measure serum vitamin D before and after treatment

Intervention Type: DRUG

Other Intervention Names

narrow band UVB

Eligibility Criteria

Inclusion Criteria

• : patients from 10 to 60 diagnosed to have psoriasis vulgaris

Exclusion Criteria

1. concomitant chronic inflammatory disease or malignancy.

2. pregnant and lactating women.

3. renal dysfunction.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Meryhan Ashraf Abdelazeem

principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

meryhan abdelazeem, master

Role: CONTACT

ashrafmeryhan7@gmail.com

01204425625

Other Identifiers

vit D and UVB in psoriasis

Identifier Type: -

Identifier Source: org_study_id