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The effect of Narrow Band Ultraviolet photo therapy on serum homocystein level before and after phototherapy in patients with skin disorder

Protocol summary

Summary
Objective: To investigate the effect of Narrow Band Ultraviolet Photo Therapy On Serum Homo-cysteine Levels in Patients Refered to Yahyanegad Hospital Of Babol. Design:(Study group: patients with dermatological disorders including psoriasis, vitiligo or atopic dermatitis that are referred to photo therapy unit at Yahyanegad hospital; Sample size:30; No control group; Building: Not blinded; Randomization: Single arm study). Setting and conduct: 30 patients that are referred to photo therapy unit of the dermatology department at Yahyanegad hospital are enrolled in to the study. Serum homocysteine levels are measured in all patients at the first visit before initiating of treatment and after thirty sessions of treatment. Serum homo cysteine levels are determined using Elisa method. Software SPSS are used to analyze the results. Inclusion criteria: psoriasis or Vitiligo, which is set to be at least 30 sessions of narrow band ultraviolet photo therapy. Signing the informed consent before entering the examination Exclusion criteria: Smoking, illnesses such as hypertension, diabetes, thyroid dysfunction that may affect homocysteine levels. Use of drugs, such as vitamins, OCP and anti-coagulant, past history of cardiovascular, chronic hepatitis, chronic kidney disease, cancer and pregnancy, inflammatory bowel disease, rheumatic diseases, systemic drugs anti-psoriasis or Vitiligo, Use of natural or synthetic UV for during the months prior to admission natural or synthetic. Patients who did not complete therapy by the end of 30 sessions. Intervention: Narrow Band Ultra Violet B photo therapy; thirty session of treatment. Primary outcome variables: serum homocysteine levels; Secondary outcome variable Ultraviolet cumulative doses

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017060134286N1
Registration date: 2017-10-15, 1396/07/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Zeinab Aryanian
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1551
Email address
z.aryanian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2016-09-03, 1395/06/13
Expected recruitment end date
2018-03-22, 1397/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Narrow Band Ultraviolet photo therapy on serum homocystein level before and after phototherapy in patients with skin disorder
Public title
The effect of phototherapy on serum homocystein level
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: psoriasis or Vitiligo, which is set to be at least 30 sessions of light therapy NBUVB. signing the informed consent before entering the examination Exclusion criteria: Smoking, illnesses such as hypertension, diabetes, thyroid dysfunction that may affect homocysteine levels. Use of drugs; such as vitamins, OCP and anti-coagulant. past history of cardiovascular, chronic hepatitis, chronic kidney disease, cancer and pregnancy, inflammatory bowel disease, rheumatic diseases. systemic drugs anti-psoriasis or Vitiligo. Use of natural or synthetic UV for during the months prior to admission natural or synthetic. Patients who did not complete therapy by the end of 30 sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Vice chancellor for research of Babol University of Medical Sciences,Babol University of Medical Sciences,Ganjafroose street,Karegar square,Babol
City
babol
Postal code
4717631367
Approval date
2016-10-31, 1395/08/10
Ethics committee reference number
mubabol.rec.1395.174

Health conditions studied

1

Description of health condition studied
Atopic dermatitis-vitiligo-psoriasis
ICD-10 code
L20-L80-L4
ICD-10 code description
Atopic dermatitis-vitiligo-psoriasis

Primary outcomes

1

Description
Serum homocystein levels
Timepoint
Baseline (before initiation of treatment)-after 30sessions of treatment
Method of measurement
Elisa

Secondary outcomes

1

Description
Cumulative dose
Timepoint
After 30 session phototherapy
Method of measurement
j/cm

Intervention groups

1

Description
Intervention group:Narrow Band UVB photo therapy; 30 sessions of treatments; No control group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology department of Shahid Yahyanegad hospital
Full name of responsible person
Zeinab Aryanian
Street address
Shahid Yahyanegad hospital,Mostafa Khomeini street,Modares street,Babol
City
babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Babol University of Medical Sciences
Full name of responsible person
Dr.Hadi Parsiyan
Street address
Babol University of Medical Sciences,Ganjafroose street,Karegar square, Babol
City
babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zeinab Aryanian
Position
Assistant professor,Dermatologist
Other areas of specialty/work
Street address
Babol University of Medical Sciences,Ganjafroose street,Karegar square,Babol
City
babol
Postal code
4717631367
Phone
+98 11 3219 7667
Fax
Email
z_aryanian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zeinab Aryanian
Position
Assistant professor,Dermatologist
Other areas of specialty/work
Street address
Babol University of Medical Sciences,Ganjafroose street,Karegar square,Babol
City
babol
Postal code
4717631367
Phone
+98 11 3219 7667
Fax
Email
Z_aryanian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zeinab Aryanian
Position
Assistant professor,Dermatologist
Other areas of specialty/work
Street address
Babol University of Medical Sciences,Ganjafroose street,Karegar square,Babol
City
babol
Postal code
4717631367
Phone
+98 11 3219 7667
Fax
Email
z_aryanian@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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