main goal of the study:
comparison of topical ۵% Methimazole and 4 % Hydroquinone effect on melasma
Design
Clinical trial with a control group in the same patient, without blinding and not randomized, phase 2-3 on 30 patients.
Settings and conduct
The studied patients are 30 patients with melasma and they visited the skin clinic of Sinai Hospital in the fall and winter of 1401. Methimazole 5% topical cream, which is formulated, is provided to the patients and they are asked to apply once a day to Apply this cream on the right side of your cheek and use 5% topical hydroquinone cream on the left side of your cheek.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1)Age above 18 years and below 50 years
2)informed consent to participate in the study
3) presence of melasma on both sides of the cheeks
Exclusion criteria
۱) having no consent to participate in the study
2) pregnancy or lactation
3) history of sensitivity to Tiamazoles
4) history of using other topical drugs for melanoma in past 3 months
5) thyroid dysfunction
Intervention groups
The formulated 5% topical methimazole cream is provided to the patients and they are asked to apply this cream once a day to the right side of their cheek and apply 5% topical hydroquinone cream to the left cheek. .
Main outcome variables
Severity of melasma lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002581N9
Registration date:2023-02-21, 1401/12/02
Registration timing:prospective
Last update:2023-02-21, 1401/12/02
Update count:0
Registration date
2023-02-21, 1401/12/02
Registrant information
Name
Hamide Herizchi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4650
Email address
herizchih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of topical Methimazole 5% versus topical Hydroquinone 4% on the improvement of melasma lesions
Public title
Comparison of topical ۵% Methimazole and 4 % Hydroquinone effect on melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age higher than 18 years and below 50 years
Informed consent participate in the study
Presence of melanoma in both sides of cheeks
Exclusion criteria:
Lack of consent to participate in the study
Pregnancy or lactation
History of sensitivity to Tiamazoles
Thyroid dysfunction
History of using other topical drugs for melanoma in past 3 months
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
the patient uses the Methimazole cream in one side of cheek and Hydroquinone in other side as in control
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for research of Tabriz University of Medical Sciences
Street address
Research centre , 3th floor, Central building number 2,Tabriz University of Medical Sciences,Golgasht street ,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۳۱۲۳۲
Approval date
2022-11-22, 1401/09/01
Ethics committee reference number
IR.TBZMED.REC.1401.771
Health conditions studied
1
Description of health condition studied
melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Severity of melasma lesions
Timepoint
1, 4, 8 and 12 months after treatment
Method of measurement
Clinical examination and comparison of photos and use of Hemi Masi score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 5% topical methymazole cream that has been formulated in Tabriz University of Medical Sciencses Faculty of Pharmacy, is provided to the patients and they are asked to apply this cream to the right side of their cheek once a day. Patients are followed up at intervals of 4, 8, and 12 weeks, and their recovery rate, satisfaction, and Masi score are checked for them. Thyroid function tests are also requested again in the 8th week. The side effects and recovery rate will be checked based on the mentioned cases at the end of the 12th week.
Category
Treatment - Drugs
2
Description
Control group: 5% topical hydroquinone cream that has been formulated in Tabriz University of Medical Sciences Faculty of Pharmacy,is provided to the patients and they are asked to apply this cream to the right side of their cheek once a day. Patients are followed up at intervals of 4, 8, and 12 weeks, and their recovery rate, satisfaction, and Masi score are checked for them. Thyroid function tests are also requested again in the 8th week. The side effects and recovery rate will be checked based on the mentioned cases at the end of the 12th week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr Hamideh Herizchi-Ghadim
Street address
Maralan street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Email
Drherizchi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamideh Herizchi - Ghadim
Street address
Maralan ( Azadi) street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Email
Drherizchi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hamideh Herizchi- Ghadim
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
dermatologist
Street address
Dermatology ward , Sina hospital,Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1540 6612
Email
dr.herizchi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr Hamideh Herizchi- Ghadim
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
dermatologist
Street address
Dermatology ward, Sina hospital, Azadi street , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1540 6612
Email
dr.herizchi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamideh Herizchi Ghadim
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
dermatology
Street address
Dermatology clinic, Sina hospital, Maralan street , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Email
herizchih@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data of the study are classified and coded so that the names of the people cannot be identified.
When the data will become available and for how long
Access starts from the beginning of data collection
November 1401
To whom data/document is available
For researchers in academic institutions
Under which criteria data/document could be used
In order to use in other studies
From where data/document is obtainable
To me, Hamida Harizchi Ghadim, all the ways of communication have been mentioned in the previous section
Priority through phone call , Email and then SMS
Shaghayegh Babapoor through phone call, SMS and E-mail
What processes are involved for a request to access data/document
After receiving the request via phone call or SMS and email, it will be sent within a week.