in this interventional study;60 female patients come down with melasma that refer to the dermatologic clinic of the rasool hospital from 2015 to 2016;then are divided into two groups;
interventional group and control group and then the intervention group treat with tranexamic acid twice a day;the control group use topical hydroquinone 4% at night;two groups in term of response to treatment will be evaluated and compared with each other at week 8 & 12.
inclusion criteria:
1.female gender;2.suffering melasma
exclusion criteria:
1.lack of compliance to continue the treatment;2.developed side effect of the treatment.
General information
Acronym
MASI:melasma assessment severity index
IRCT registration information
IRCT registration number:IRCT2016040627220N2
Registration date:2016-06-13, 1395/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-13, 1395/03/24
Registrant information
Name
Behzad Dalvand
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 0897
Email address
dalvandb@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of topical tranexamic acid in compare with topical hydroquinone4% is used in women with melasma
Public title
the effect of topical tranexamic acid in compare with topical hydroquinone4% is used in women with melasma
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
1.female gender,2.suffering melasma
exclusion criteria:
1.lack of compliance to continue the treatment,2.developed side effect of the treatment.
Age
No age limit
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
accidental number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Iran University of Medical Sciences
Street address
Iran university-Hemmat highway
City
Tehran
Postal code
19922347512
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
IR.IUMS.REC.1394.9211166002
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
Timepoint
8 weeks and 12 weeks later
Method of measurement
photography
Secondary outcomes
1
Description
rate of the lightening of the skin affected with melasma
Timepoint
8 weeks and 12 weeks later
Method of measurement
photography and determining rate of MASI
Intervention groups
1
Description
control group:apply topical hydroquinone4% seagull company nightly for 3 months
Category
Treatment - Drugs
2
Description
intervention group:apply topical tranexamic acid 5% manufactured by pharmacy of Hazrat Rasool Akram hospital of Tehran nightly for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool hospital
Full name of responsible person
Najm-alsadat atefi
Street address
Sattarkhan street-Niayesh street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Dr.Ali javad mousavi
Street address
Iran university-Hemmat highway
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University Medical Sciences
Full name of responsible person
Dr.Najm-alsadat atefi
Position
professor
Other areas of specialty/work
Street address
dermatology department;Rasool hospital;Sattarkhan street
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 6650 2040
Email
Dalvandb@tak.iums.ac.ir
Web page address
www.iums.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr.Najm-alsadat atefi
Position
professor
Other areas of specialty/work
Street address
dermatology department;Rasool hospital;Sattarkhan street
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 6650 2040
Email
Dalvandb@tak.iums.ac.ir
Web page address
www.iums.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Behzad dalvand
Position
resident of dermatology
Other areas of specialty/work
Street address
dermatology department;Rasool hospital;Sattarkhan street
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 8835 0897
Email
Dalvandb@tak.iums.ac.ir
Web page address
www.iums.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)