Investigating the effect of topical tranexamic acid compared to oral tranexamic acid in patients with melasma
Design
Control-controlled clinical trial with parallel, double-blind, randomized, phase 3 groups on 50 patients. In order to randomize, the block random allocation method was used.
Settings and conduct
This study will be performed on patients with melasma referred to Khatam Al-Anbia Clinic in Yazd. 25 patients in the first group will receive 5% topical tranexamic acid cream and 25 patients in the second group will receive 250 mg tranexamic acid capsules orally twice a day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: omen with melasma from 18 to 60 years
MMASI score greater than 8.5
Do not use oral contraceptives
The patient has not received medication to treat melasma in the last three months
Exclusion criteria: Drug Allergy
Breastfeeding
Intervention groups
In order to compare the effectiveness of tranexamic acid cream with its oral capsule in the treatment of melasma, we give a group of 25 people transexamic acid cream and a group of 25 people tranexamic acid oral capsule.
Main outcome variables
Melasma intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N9
Registration date:2023-10-09, 1402/07/17
Registration timing:retrospective
Last update:2023-10-09, 1402/07/17
Update count:0
Registration date
2023-10-09, 1402/07/17
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-20, 1401/02/30
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of topical tranexamic acid versus oral tranexamic acid in the treatment of melisma: a randomized, double-blind clinical trial.
Public title
Evaluation of topical tranexamic acid effectiveness in the treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with melasma from 18 to 60 years
MMASI score greater than 8.5
Do not use oral contraceptives
The patient has not received medication to treat melasma in the last three months
Exclusion criteria:
Drug allergy
Breastfeeding
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 50 patients were randomly divided into two treatment groups (A and B). In order to randomize, the block random allocation method was used, in which 10 blocks of 5 were considered. The letters A and B. These permutations were generated with the help of Random software distribution software version 1. For this purpose, the list prepared by software No. 1 to 50 is in 10 blocks of five in general to implement this I want the software output to the first eligible person number 1 and I want to select the last person number 50.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, the physician, and the assessor of clinical symptoms will be all blinded to the intervention’s assignments during performing the study. In this way, the first executor of the sequence plan determines the allocation of individuals according to the order in which patients enter the study and delivers the appropriate medications to the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.065
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Evaluation of of melasma improvement
Timepoint
Weeks 0, 4, 8
Method of measurement
MASI ( Melasma Area Severity Index) Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with melasma use Tranexamic acid capsules 250 mg orally twice a day for 8 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Patients with melasma use 5% tranexamic acid cream (manufactured in Yazd Faculty of Pharmacy) topically twice a day for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al Anbia Clinic, Yazd
Full name of responsible person
Mohammad Ebrahimzadeh Ardakani
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3146 2150
Email
mohammad110eb@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abarghouei
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3146 2150
Email
abargouei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.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
Yes - There is 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
After nonrecognition, all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
nothing
From where data/document is obtainable
Behrooz Heydari email: b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your information by email. The data will be sent after a week.