Combined Oral Vitamin D and UVB Versus UVB Alone in Treatment of Psoriasis Vulgaris
Primary Purpose
Psoriasis Vulgaris
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
oral vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
Eligibility Criteria
Inclusion Criteria:
- : patients from 10 to 60 diagnosed to have psoriasis vulgaris
Exclusion Criteria:
- concomitant chronic inflammatory disease or malignancy.
- pregnant and lactating women.
- renal dysfunction.
Sites / Locations
Outcomes
Primary Outcome Measures
measure serum vitamin D before and after treatment in psoriatic patients
A 3ml blood sample will be collected from the patients, then allowed to clot for 10 minutes and then centrifuged .
Group 1: 20 patients under oral vitamin D therapy ( oral alpha one for 3 months o.25 microgram / day ) in combination with narrow band UVB settings (twice/week) Group 2 : 20 patients under narrow band UVB therapy only . c) We evaluate psoriatic patient by PASI score before and after treatment :
) measurment vitamin D level before and after treatment.
Secondary Outcome Measures
We evaluate psoriatic patient by PASI score before and after treatment :
The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)).
Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 to 6:
0.0% of involved area
1.< 10% of involved area 2.10-29% of involved area 3.30-49% of involved area 4.50-69% of involved area 5.70-89% of involved area 6.90-100% of involved area
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03874975
Brief Title
Combined Oral Vitamin D and UVB Versus UVB Alone in Treatment of Psoriasis Vulgaris
Official Title
Combined Oral Vitamin D and UVB Versus Alone in Treatment of Psoroasis Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
40 patients divided into two groups : group 1 :20 patients underoral vitamin D and UVB group 2 : 20 patients under uvb alone in psoriatic patients
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
oral vitamin D
Other Intervention Name(s)
narrow band UVB
Intervention Description
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
Primary Outcome Measure Information:
Title
measure serum vitamin D before and after treatment in psoriatic patients
Description
A 3ml blood sample will be collected from the patients, then allowed to clot for 10 minutes and then centrifuged .
Group 1: 20 patients under oral vitamin D therapy ( oral alpha one for 3 months o.25 microgram / day ) in combination with narrow band UVB settings (twice/week) Group 2 : 20 patients under narrow band UVB therapy only . c) We evaluate psoriatic patient by PASI score before and after treatment :
) measurment vitamin D level before and after treatment.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
We evaluate psoriatic patient by PASI score before and after treatment :
Description
The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)).
Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 to 6:
0.0% of involved area
1.< 10% of involved area 2.10-29% of involved area 3.30-49% of involved area 4.50-69% of involved area 5.70-89% of involved area 6.90-100% of involved area
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
: patients from 10 to 60 diagnosed to have psoriasis vulgaris
Exclusion Criteria:
concomitant chronic inflammatory disease or malignancy.
pregnant and lactating women.
renal dysfunction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
meryhan abdelazeem, master
Phone
01204425625
Email
ashrafmeryhan7@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Combined Oral Vitamin D and UVB Versus UVB Alone in Treatment of Psoriasis Vulgaris
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