Formulation and Clinical Trial of a Traditional Dosage Form for Skin Depigmentation and Comparison to a Marketed Preparation in Two Groups of Patients Suffering From Vitiligo
The aim of this study is to study natural dyes in traditional Persian text books and to formulate a camouflage formulation to cover skin patches of patients suffering from skin depigmentation and to perform a clinical trial on the formulation to investigation the effect of the formulation on the quality of life of the patents. To achieve that goal we are performing the clinical trial on two groups of fifteen patients. One group would be using our formulation and the other group would be using the marketed camouflage formulation. To investigate the quality of life, each group is asked to fill up DLQI questionnaire before, after and during intervention; the two formulations would be used twice daily for forty days and the questionnaire would be filled in 10 day intervals as well during the study. To investigate the possible curative effect of the two formulations an imaging technique is established and used in this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205029618N1
Registration date:2012-08-27, 1391/06/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-27, 1391/06/06
Registrant information
Name
Ayda Hosseinkhani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1242 4255
Email address
hoseinkhan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-08-05, 1391/05/15
Expected recruitment end date
2012-11-05, 1391/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation and Clinical Trial of a Traditional Dosage Form for Skin Depigmentation and Comparison to a Marketed Preparation in Two Groups of Patients Suffering From Vitiligo
Public title
Effect of a Traditional Dosage Form on the quality of life of the patents suffering from vitiligo and Comparison to a Marketed Preparation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: vitiligo patients from 20-60 yrs.
Exclusion criteria: under any vitiligo treatments.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
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
Street address
Shiraz University of Medical Sciences, Zand Ave. Shiraz Iran
City
Shiraz
Postal code
Approval date
2012-02-25, 1390/12/06
Ethics committee reference number
ct-90-5958
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
A67.2
ICD-10 code description
vitiligo, pinta
Primary outcomes
1
Description
Quality of Life of Patients
Timepoint
before and after intervention in 10 day intervals to 40 days
Method of measurement
use of DLQI questionare
Secondary outcomes
1
Description
change of skin patches color
Timepoint
before and after intervention in 10 day intervals to 40 days
Method of measurement
imaging and use of the software
Intervention groups
1
Description
In the Intervention group the formulation under study is used twice a day as a camouflage for 40 days
Category
Treatment - Drugs
2
Description
In the control group the marketed cosmetic product is used twice a day as a camouflage for 40 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz School of Pharmacy
Full name of responsible person
Ayda Hosseinkhani
Street address
Akbar aabad, Shiraz School of Pharmacy.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiarz University of Medical Sciences
Full name of responsible person
Abdolali Mohagheghzadeh
Street address
Zand Ave, Shiarz University of Medical Sciences.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiarz 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 School of Pharmacy
Full name of responsible person
Ayda Hosseinkhani
Position
Ph.D Student of Traditional Persian Pharmacy
Other areas of specialty/work
Street address
Akbar aabad, Shiraz School of Pharmacy.
City
Shiraz
Postal code
Phone
+98 71 1242 4255
Fax
+98 71 1242 4255
Email
hoseinkhan@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz School of Pharmacy
Full name of responsible person
Abdolali Mohagheghzadeh
Position
Pharmacognosy Professor, Ph.D
Other areas of specialty/work
Street address
Zand Ave, SHiraz University of Medical Siences.
City
Shiraz
Postal code
Phone
+98 71 1230 7593
Fax
+98 71 1230 7593
Email
mohaghegh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz School of Pharmacy
Full name of responsible person
Ayda Hosseinkhani
Position
Ph.D Student of Traditional Persian Pharmacy
Other areas of specialty/work
Street address
Akbaraabad, Shiraz School of Pharmacy.
City
Shiraz
Postal code
Phone
+98 71 1242 4255
Fax
+98 71 1242 4255
Email
hoseinkhan@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)