This study aimed to compare the therapeutic effect of oral and topical tranexamic acid in patients with melasma. The main inclusion criterion is the age between 20 and 70 years. The main exclusion criteria of the study are pregnancy; underlying skin disease; skin infection such as impetigo; the use of skin peeling therapies and a history of drug allergy. Among patients attending to dermatology clinic of Tabriz Sina Hospital with diagnosis of melasma, 90 patients will be divided in three groups of 30 subjects and will be studied. In the first group only hydroquinone cream, in the second group hydroquinone cream with tranexamic acid capsules orally, and in the third group hydroquinone cream and topical tranexamic acid will be used. Patients will be reviewed monthly and for each patient special forms will be filled out. Melasma severity depending on the extent of facial involvement, the degree of darkness and the homogeneity of the hyperpigmentation will be rated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411033566N7
Registration date:2014-11-20, 1393/08/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-11-20, 1393/08/29
Registrant information
Name
Hamide Azimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
azimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of oral and topical tranexamic acid in the treatment of patients with facial melasma receiving topical hydroquinone
Public title
Comparison of topical and oral treatments of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion:patients with facial melasma; patients between 20 and 70 years old. Exclusion criteria: pregnancy; underlying skin diseases; thyroid disease; history of drug allergy; previous use of contraceptives or phenytoin; patients with uncontrolled hypertension; patients with skin infections such as Impetigo; a history of coagulation or thrombosis; skin peeling treatments to treat existing disease; persons aged less than 20 years and more than 70 years old.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Postal code
Approval date
2014-09-29, 1393/07/07
Ethics committee reference number
93105
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
The extent of facial skin involvement in percentage
Timepoint
At the first visit and then monthly up to 3 months.
Method of measurement
Usin MASI scoring system
2
Description
degree of melasma darkness compairing to normal skin
Timepoint
At the first visit and then monthly up to 3 months.
Method of measurement
Usin MASI scoring system
3
Description
Homogeneity of the melasma hyperpigmentation
Timepoint
At the first visit and then monthly up to 3 months.
Method of measurement
Usin MASI scoring system
Secondary outcomes
empty
Intervention groups
1
Description
The first group will only be treated with hydroquinone 2% cream evey night for 12 weeks.
Category
Treatment - Drugs
2
Description
The second group will be treated with hydroquinone 2% cream every night and tranexamic acid capsules 250 mg PO/BID for 12 weeks.
Category
Treatment - Drugs
3
Description
The third group will be treated with hydroquinone 2% cream every night and topical tranexamic acid cream 500mg daily for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Sina Hospital
Full name of responsible person
Anali Sadeghi
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Ali Reza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Anali Sadeghi
Position
MD, resident of Dermatology
Other areas of specialty/work
Street address
Dermatology ward, Sina Hospital, Azadi Ave
City
Tabriz
Postal code
Phone
Fax
Email
analisadeghi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamide Azimi
Position
Dermatologist/Associate professor
Other areas of specialty/work
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Postal code
Phone
Fax
Email
hamide-azimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Izadseresht
Position
Medical student
Other areas of specialty/work
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Postal code
Phone
Fax
Email
b.izadseresht@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)