One of the causes of vitiligo is accumulation of toxic H2O2 for melanocytes in epidermis. Because H2O2 is strong scavenger of ethyl vanillate, we decided to evaluate the enhancing efficacy of phototherapy via concomitant use of ethyl vanillate cream. It is a double blind, randomized, with placebo, monocentric study. 25 patients with generalized bilateral depigmented lesions are selected from phototherapy patients. Pregnant women, children under 6 years of age, patients with past history of skin cancer and patients taking immunosuppresive medications are excluded from study. Patients use 20 percent ethylvanillate cream on the lesions of one side and placebo on the other side (same place) twice daily. At the begining and the end of 4th, 8th and 12th weeks, photo is taken from patient and the result is judged by vitiligo area severity index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107317160N1
Registration date:2012-03-03, 1390/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-03, 1390/12/13
Registrant information
Name
Nasrin Hamidizadeh
Name of organization / entity
Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
hamidizade@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences
Expected recruitment start date
2012-02-29, 1390/12/10
Expected recruitment end date
2012-04-08, 1391/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of topical ethyl vanillate in enhancing the effect of phothotherapy against vitilligo
Public title
Evaluation of the efficacy of topical ethyl vanillate in treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Pateints with bilateral generalized depigmented lesions are selected among phototherapy patients. Pregnant women, children under 6 years of age, patients with past history of skin cancer, and patients taking immunosuppresive medications, are excluded from study.
Age
From 7 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
Zand street
City
Shiraz
Postal code
71345-1978
Approval date
2012-02-09, 1390/11/20
Ethics committee reference number
CT-90-3321
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
pigmentation of lesions
Timepoint
before intervention 1, 2, 3 months after intervention
Method of measurement
vitiligo area severity index scale
Secondary outcomes
1
Description
erythema of lesion
Timepoint
at the end of months 1, 2, 3 after intervention
Method of measurement
taking photo
Intervention groups
1
Description
topical ethyl vanillate 20 percent on the lesion of one side twice daily for 3months
Category
Treatment - Drugs
2
Description
topical eucerin (placebo) on the other side (same place) twice daily for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic, Shahid Faghihi hospital
Full name of responsible person
Amir Kalafi Shotorbani
Street address
Dermatology clinic, Faghihi hospital, Zand street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz university of medical sciences
Full name of responsible person
Gholamreza Hatam
Street address
Zand street
City
Shiraz
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, Shiraz 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
Shiraz university of medical sciences
Full name of responsible person
Amir Kalafi Shotorbani
Position
Dermatology resident/md
Other areas of specialty/work
Street address
Dermatology clinic, Faghihi hospital, Zand street
City
Shiraz
Postal code
7134844119
Phone
+98 71 1231 9049
Fax
+98 71 1233 1634
Email
kalafia@sums.ac.ir , amirkalafi@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Amir Kalafi Shotorbani
Position
Dermatology resident/MD
Other areas of specialty/work
Street address
Dermatology clinic, Faghihi hospital, Zand street
City
Shiraz
Postal code
7134844119
Phone
+98 71 1231 9049
Fax
+98 71 1233 1634
Email
kalafia@sums.ac.ir , amirkalafi@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)