Comparison of the effect of intranasal injection of tranexamic acid 100 mg / ml in comparison with topical hydroquinone cream 4% in the treatment of melasma
Design
In this clinical trial which is parallel group, double-blind, randomized, phase 3 trial, 48 people who will refer to the dermatology clinic of Imam Khomeini Hospital in Ahwaz will participate.
Settings and conduct
This study will be carried out in the dermatology clinic of Imam Khomeini Hospital in Ahvaz and among the clients who will refereed for the treatment of melasma.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female, age of 18-50 years old, with facial melasma.
Exclusion criteria: Pregnant and lactating women, history of melasma treatment during the past month, active facial Herpes simplex lesions, Any history of coagulopathy and thrombotic problems
Intervention groups
Intervention group 1: intradermal injection of tranexamic acid ampoule into melasma areas will be performed at 2 weeks intervals for 3 months.
Intervention group 2: treatment with topical 4% hydroquinone will be performed. The duration of treatment will be 12 weeks, and the response will be evaluated every 4 weeks
Main outcome variables
The degree of melasma treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180909040979N5
Registration date:2020-01-03, 1398/10/13
Registration timing:registered_while_recruiting
Last update:2020-01-03, 1398/10/13
Update count:0
Registration date
2020-01-03, 1398/10/13
Registrant information
Name
MARYAM ZAMANKHANI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 4760
Email address
zamankhani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-07, 1398/09/16
Expected recruitment end date
2020-09-06, 1399/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of intradermal injecting of tranexamix acid and hydroquinone cream in the treatment of melasma
Public title
The effect of tranexamic acid and hydroquinone in melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female sex
Being at the age of 18-50 years old
Facial melasma
Exclusion criteria:
Pregnant and lactating women
History of melasma treatment over the past month
Active herpes simplex lesions on the face
Sensitivity to the drugs in the study
Coagulopathy
Warts on the face
Use of anticoagulant and anticonvulsant drugs
Contraceptive use during the past 12 months and during the study
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups based on block randomization method. Randomized blocks are used for this purpose. A random sample based on this method from Sealedenvelope.com has been extracted.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Vice Chancellor for Research; Ahvaz Jundishapur University of Medical Sciences; Golestan blvd
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.AJUMS.REC.1398.652
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The degree of melasma treatment
Timepoint
Before treatment, at 4th, 8th and 12th week during the treatment and three months after the end of the treatment
Method of measurement
MASI score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In group A, after application of topical anesthetic cream (lidocaine + prilocaine) 30 minutes before injection, tranexamic acid ampule, 100 mg/ml (manufactured by Caspian Supply Company) will be injected intradermally into melasma areas at 1 cm intervals, every 2 weeks for 3 months. The 1CC insulin syringe will be used for injection.
Category
Treatment - Drugs
2
Description
Intervention group 2: Group B will be treated with topical hydroquinone 4% every night. The duration of treatment will be 12 weeks, and the response will be evaluated every 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Nader Pazyar
Street address
Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3292 1837
Email
Dr.pazyar@gmail.vom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Badavi
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 3738
Email
mbadavi@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Motahareh Babazadeh
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3292 1837
Email
Dr.pazyar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nader Pazyar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3292 1837
Email
Dr.pazyar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Motahareh Babazadeh
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3292 1837
Email
Dr.pazyar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No decision has been made yet
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available