- Comparison of the efficacy of 4 and 10 mg/ml intradermal injected Tranexamic Acid vs 4% Hydroquinone cream in the treatment of melasma
- Comparison of incidence of adverse effect of Tranexamic acid between two therapeutic
Design
Split face randomised blinded parallel control group trial with 20 person at each group. RCT is in phase II
Settings and conduct
Patients with inclusion criteria divded in two groups with permuted four block randomization at dermatology departemant of Imam Hospital in Ahwaz city.Right face treated with intradermal of tranexamic acid with 4 mg/ml in one group 10 mg/ml in another group every other week for 12 weeks and left face treated with hydroquinon 4% twice a day for 12 weeks.Patients and value assessment blind to dose of Tranexamic acid.
Participants/Inclusion and exclusion criteria
- Inclusion criteria:
Women with symmetrical bilateral melasma who signature the letter of satisfaction
- exclusion criteria:
Pregnant and lactating women
Oral contraceptive pill consumption in 12 months ago during RCT
History of coagulopathy and thrombotic disorder
Anticoagulant and antiepileptic drug consumption
Sensitivity to tranexamic acid
History of treatment for melasma during 1 month ago
Active facial herpes simplex virus infection
Facial wart
Intervention groups
Right face treated with intradermal of tranexamic acid with 4 mg/ml in one group 10 mg/ml in another group every other week for 12 weeks and left face treated with hydroquinon 4% twice a day for 12 weeks
Main outcome variables
Decrease in melasma area and severity index ; Increase patients satisfaction
General information
Reason for update
Acronym
AMS
IRCT registration information
IRCT registration number:IRCT20180203038599N1
Registration date:2018-03-26, 1397/01/06
Registration timing:retrospective
Last update:2018-03-26, 1397/01/06
Update count:0
Registration date
2018-03-26, 1397/01/06
Registrant information
Name
Maryam Zeynalie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3392 4392
Email address
zeynalie.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of Intradermal injected Tranexamic Acid vs Hydroquinone cream in the Treatment of Melasma
Public title
Comparison of the Efficacy of Intradermal injected Tranexamic Acid vs Hydroquinone cream in the Treatment of Melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women at the range of 18 to 50 years old
with symmetrical bilateral melasma
who signature the letter of satisfaction
Exclusion criteria:
Pregnant and lactating women
Oral contraceptive pill consumption in 12 months ago during RCT
History of coagulopathy and thrombotic disorder
Anticoagulant and antiepileptic drug consumption
Sensitivity to tranexamic acid
History of treatment for melasma during 1 month ago
Active facial herpes simplex virus infection
Facial wart
`
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Right face treated with intradermal of tranexamic acid and left face treated with hydroquinon 4%
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted 4 block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Value assessment blind about 4 and 10 mg/ml tranexamic acid dose.
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
No. 11, East Kiyanpars
City
Ahvazَ
Province
Khouzestan
Postal code
6155964375
Approval date
2018-01-29, 1396/11/09
Ethics committee reference number
IR.AJUMS.REC.1396.1091
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Melasma area and severity index
Timepoint
Melasma area and severity index measured at base of trial and 4, 8, 12 and 22
Method of measurement
Melasma area and severity index score
Secondary outcomes
1
Description
patients satisfaction
Timepoint
Measuring of patient satisfaction in 8, 12 and 22 week of trial
Method of measurement
Satisfaction percentage questionnaire
Intervention groups
1
Description
Intervention group 1: Right side face treated with intradermal 4 mg/ml tranexamic acid every other week for 12 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: Right side face treated with intradermal 10 mg/ml tranexamic acid every other week for 12 weeks. Tranexamic acid is a product of Caspian Tamin Pharmaceutical Company in 500 mg/5ml vial.
Category
Treatment - Drugs
3
Description
Control group: Left side face treated with eldoquin fort 4% cream is a product of ICN company twice a day for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ِDermatology department, Imam hospital,Ahvaz
Full name of responsible person
Maryam Zeynalie
Street address
Imam khomeini medicinal academic center, Azadegan street
City
َAhvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 1292 1837
Email
zeynalie.m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ground floor, Vice chanceller of Research, Ahvaz Jundishapur University of Medical Sciences, Daneshgahi town, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
zeynalie.m@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
Maryam Zeynalie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Unit. 4., No. 54 , Street 11., East Kiyanpars.,
City
Ahvaz
Province
Khouzestan
Postal code
6155964375
Phone
+98 61 3392 4392
Email
zeynalie.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Zeynalie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Unit. 4, No.54 ,East 11 St, Kiyanpars
City
Ahvaz
Province
Khouzestan
Postal code
6155964375
Phone
+98 61 3392 4392
Fax
Email
zeynalie.m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Zeynalie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Unit. 4., No. 54 , Street 11., East Kiyanpars.,
City
Ahvaz
Province
Khouzestan
Postal code
6155964375
Phone
+98 61 3392 4392
Email
zeynalie.m@ajums.ac.ir
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
Undecided - It is not yet known if there will be 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