To evaluate the effectiveness of Turmeric cream in treatment of Vitiligo lesions.
Design
A controlled pilot randomized double blind clinical trial
Settings and conduct
Thirty patients diagnosed with Vitiligo by the consultant dermatologist who will be referred to the Skin and Stem Cell Research Center of Tehran University of Medical Sciences will be considered to be included in our investigation. The quality of life index and photos from lesions will be used for the assessment of our patients. These parameters will be collected at baseline and monthly intervals for up to four months. The total duration of this research will be four month. The patients, researcher, observer dermatologist, and analyses will be blinded thorough out this investigation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with stable disease for at least 3 months ; Less than 20% of body involvement and symmetrical lesions.
Non-inclusion criteria: Generalized and progressive vitiligo ; pregnancy or lactation ; allergy to Curcumin ; resistant to other vitiligo therapies and malignant or active skin infections.
Intervention groups
Intervention group 1: effectiveness of turmeric cream in improvement of vitiligo lesions ; this cream will be used twice daily for 4 months.
Intervention group 2: effectiveness of placebo in improvement of vitiligo lesions ; this cream will be used twice daily for 4 months.
Main outcome variables
size of lesions , noticeability of lesions and percentage of re-pigmentation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180910040994N1
Registration date:2019-08-05, 1398/05/14
Registration timing:retrospective
Last update:2019-08-05, 1398/05/14
Update count:0
Registration date
2019-08-05, 1398/05/14
Registrant information
Name
Samin Jalalmanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 4858
Email address
s.j1994@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2018-10-20, 1397/07/28
Actual recruitment end date
2019-05-14, 1398/02/24
Trial completion date
2019-09-21, 1398/06/30
Scientific title
Evaluation of local effects of Turmeric drug in improvement of lesions in patients with vitiligo in comparison to placebo
Public title
Effect of Turmeic in treatment of Vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from vitiligo
Stability of lesions for at least 3 months
Less than 20 percent of skin involvement
Having symmetrical lesions
Exclusion criteria:
Generalized or progressive vitiligo
pregnancy or lactation
any history of allergy to Curcumin
patients who are resistant to other vitiligo therapies such as immunomodulators drugs , photo-therapy and etc.
any malignancy or active skin infections
Age
From 8 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Lesions with equal size and intensity on the left and right side were chosen for the trial.
Actual sample size reached:
30
More than 1 sample in each individual
Actual sample size in each individual:
2
Lesions with equal size and intensity on the left and right side were chosen for the trial.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method is used in left and right subgroups in which one side is always for drug and the other side is always for placebo. A package is given to patients containing 2 creams, including turmeric cream and placebo. The placebo is devoid of the active ingredient of Curcumin and is otherwise similar to the drug. These two creams is labeled with right and left by a third person that the information about them is only available to that person and the investigator, patient and observer dermatologist are not aware of the content of the creams.
The patient should apply the creams twice a day at the specified side for four months.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient , researcher and the observer dermatologist of the study are all blinded to the randomization state in the investigation.
In addition , evaluation of the efficacy of the drug will be scored by 2 blinded dermatologists by comparing before and after treatment photos at the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
pilot study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran branch, Islamic Azad University of Medical Sciences
Street address
Tehran branch, Islamic Azad University of Medical Sciences, Khaghani Street, Shariati Street
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.IAU.TMU.REC.1397.328
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
size of lesions
Timepoint
at baseline and 1,2,3 and 4 months after using the drug
Method of measurement
imagej application
2
Description
notice ability of lesions
Timepoint
at the end of the study
Method of measurement
Vitiligo Noticeability Scale Questionnaire
3
Description
percentage of re-pigmentation
Timepoint
at baseline and 1,2,3 and 4 months after using the drug
Method of measurement
taking photo under wood lamp
Secondary outcomes
1
Description
Quality of life score in patients with vitiligo
Timepoint
before initiation of treatment and after finishing it
Method of measurement
Vitiligo Quality of Life Questionnaire
Intervention groups
1
Description
Intervention group: Turmeric cream 5% produced by Seagull Laboratory will be used on the lesions, twice a day, for 4 months.
Category
Treatment - Drugs
2
Description
Control group: Moisturizing cream containing yellow color with cosmetic grade will be used on the lesions, twice a day, for 4 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center, Tehran University of Medical Siences
Full name of responsible person
Dr.Parvin Mansouri
Street address
Ground floor, No.4 , Maryam closed alley, Not reaching the crossroad of Kamraniyeh, Pasha Zahri Street. (South Kamraniyrh) , Sadr Highway
City
Tehran
Province
Tehran
Postal code
1978812345
Phone
+98 21 2221 2537
Email
mehdirj@aol.co.uk
Web page address
http://skinstemcell.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Street address
Islamic Azad University Of Pharmaceutical Sciences , Yakhchal St. , Shariati St. , Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0054
Email
fhashemian@yahoo.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Rajabi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Islamic Azad University Of Pharmaceutical Sciences , Yakhchal St. , Shariati St. , Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Fax
Email
mehdirj@aol.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Mansouri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Second floor , Shooan building , Sheybani Alley , North Kamraniyeh
City
Tehran
Province
Tehran
Postal code
1978854321
Phone
+98 21 2615 1500
Email
mansorip@sina.tums.ac.ir
Web page address
http://parvinmansouri.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samin Jalalmanesh
Position
Pharm.D Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Islamic Azad University Of Pharmaceutical Sciences , Yakhchal St. , Shariati St. , Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Fax
Email
s.j1994@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The trial results , satisfaction of treatment forms and vitiligo quality of life questionnaire and informed consent form will be supplied.
When the data will become available and for how long
on completion of our investigation.
To whom data/document is available
That will be only decided by the Author and correspondent author.
Under which criteria data/document could be used
only for approval of our research and medical purpose (patients agreements and confirmation is essential)
From where data/document is obtainable
Correspondent author
What processes are involved for a request to access data/document
an official letter to request which indicates the reasons of request.