Our goal is to evaluate the efficacy of topical tetracycline in enhancing the effect of phototherapy in treatment of vitiligo. This study is double blinded and randomized clinical trial on 30 patients with generalized stable vitiligo in phototherapy center of dermatology clinic. Pregnant or lactating women and children under 8 years old are eliminated from the study. Patients randomly apply topical tetracycline on one lesion and placebo on the other while taking phototherapy 2-3 times a week and according to photos taken from lesions and VASI (Vitiligo Area Scoring Index) score are evaluated. Intervention time is in spring 2013. Pigmentation is primary outcome measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108017160N3
Registration date:2013-07-01, 1392/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-01, 1392/04/10
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
2013-06-18, 1392/03/28
Expected recruitment end date
2013-06-29, 1392/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficay of topical tetracycline in enhancing the effect of phototherapy against vitiligo
Public title
Evaluation of efficay of topical tetracycline in enhancing the effect of phototherapy against vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
30 patients with generalized stable vitiligo(more than 20% of body surface area) are chosen. Pregnant or lactating women and children under 8 years old are eliminated from the study.
Age
From 8 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Ethics Committee
Street address
Zand street
City
Shiraz
Postal code
Approval date
2013-06-16, 1392/03/26
Ethics committee reference number
CT-P-92-5150
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Lesion pigmentation
Timepoint
Monthly
Method of measurement
Photo and VASI score
Secondary outcomes
1
Description
Erythema
Timepoint
Monthly
Method of measurement
Photo
Intervention groups
1
Description
patients randomly apply tetracycline ointment twice daily on one lesion and placebo(yellow vaseline) on the other while taking phototherapy 2-3 times weekly.then according to photos taken and vasi scores,lesions are evaluated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic, Faghihi hospital
Full name of responsible person
Street address
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
Shiraz University of Medical Sciences, 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
Position
MD, dermatology resident
Other areas of specialty/work
Street address
Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 1231 9049
Fax
Email
amirkalafi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Kalafi
Position
MD
Other areas of specialty/work
Street address
Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 1231 9049
Fax
Email
amirkalafi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Kalafi
Position
MD, resident of dermatology
Other areas of specialty/work
Street address
Faghihi hospital, Karim Khan Zand blvd
City
Shiraz
Postal code
Phone
+98 71 1231 9049
Fax
+98 71 1231 9049
Email
amirkalafi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)