The aim of this study was to compare the effects of radiation therapy Ultraviolet B Therapy and Psoralen and Ultraviolet A Therapy in Patients with vitiligo. Inclusion criteria was Patients with vitiligo aged 18 to 70 years and Exclusion criteria included previous malignancy skin, failed previous treatment with phototherapy, more than 100 sessions of phototherapy in the person's life, treatment for vitiligo in the last three months, pregnancy or breast-feeding, liver or kidney disease, lupus erythematosus and hypersensitivity to light. This cross sectional study on 60 patients with vitiligo was visited Bouali hospital and Mehregan laser center in 2013. First group (30 Patients) was treated with PUVA, 3 hours before phototherapy, consumed tablets containing the 8- methoxypsoralen and under phototherapy twice a week. The second group (30 Patients) was under UVB radiation twice a week. The number of phototherapy sessions in both groups was 15 times. Two groups were compared repigmentation, stability of repigmentation and Side effects
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051811371N4
Registration date:2016-08-19, 1395/05/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-19, 1395/05/29
Registrant information
Name
Bita Shahbazzadegan
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 2007
Email address
b.shahbaz@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Islamic Azad University
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Therapeutic Effects of UVB and PUVA Waves in Patients with Vitiligo
Public title
Effects of UVB and PUVA Waves in Vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:vitiligo patients 18 to 70 years; patients who use PUVA or UVB
Exclusion criteria: previous skin cancer; failure of previous treatment with phototherapy; more than 100 sessions of phototherapy in the person's life; treatment for vitiligo in the last three months; pregnancy and lactation; liver or kidney disease; lupus erythematosus; history of sensitivity to light;use ointment monobanzen.
Age
From 18 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University
Street address
Tehran
City
Tehran
Postal code
Approval date
2016-07-19, 1395/04/29
Ethics committee reference number
IR.IAU.TMU.REC.1395.86
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Vitiligo
Timepoint
Three months every two weeks and And in the next three months per month
Method of measurement
Observe and record
Secondary outcomes
empty
Intervention groups
1
Description
In first group that were treated with PUVA (30 patients), oral tablets containing 8-methoxypsoralen at a dose of 25 mg/ m2 were taken 3 hours before phototherapy and PUVA therapy was started at a dose of 0.5 J/cm2 twice a week. The phototherapy dose was increased by 20% in each visit if tolerated.
Category
Treatment - Drugs
2
Description
In second group (30 patients), UVB therapy was administered twice a week with 311-313 nm wavelength and a dose of 0.1 J/cm2 and we increased the dose 20% in each visit if tolerated.Phototherapy sessions in both groups were 15
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
BOUALI hospital and MEHREGAN laser center
Full name of responsible person
Marjan Entezami
Street address
Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hasan Eftekhar ardebili
Street address
Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Ardabil University of Medical Sciences
Full name of responsible person
BIta Shahbazzadegan
Position
PhD
Other areas of specialty/work
Street address
Ardabil,Daneshgah st.Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 453351200
Fax
Email
bitashahbaz2004@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marjan Entezami
Position
General practitioner
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 912 810 5286
Fax
Email
marjanentezami@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Bita Shahbazzadegan
Position
PhD
Other areas of specialty/work
Street address
Ardabil,Daneshgah st.Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 3351 2000
Fax
Email
bitashahbaz2004@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)