High prevalence of melasma and its great psychological impacts necessitate efficacious ,economical and safe therapeutic interventions. This study is a double - blinded randomized controlled clinical trial aiming to evaluate the efficacy and safety of tranexamic acid in the treatment of melasma. One hundred patients (age 18-65 years old) with symmetric facial melasma lesions, no history of cardiovascular diseases, cerebrovascular diseases and deep vein thrombosis which were not pregnant, lactating or undergone depigmentation therapy within 3 months prior to entrance into the study will be enrolled. Patients will randomly be divided into two groups. The intervention group will receive tranexamic acid , 250 mg orally thrice daily plus 4% hydroquinone cream once at night-time, while the control group will be treated only with 4% hydroquinone cream applied once nightly for a period of 3 months. Patients will be photographed after one and three months of treatment as well as three months after treatment discontinuation. Two independent and blinded dermatologists will assess clinical improvement using melasma area and severity index and relapse will be noted. Moreover,patients will be asked about treatment side effects and patient satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091914715N1
Registration date:2014-01-01, 1392/10/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-01, 1392/10/11
Registrant information
Name
Afsane Ghayoumi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7790 6152
Email address
a_ghayoumi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Reasearch of Tehran University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of oral tranexamic acid in Melasema
Public title
Efficacy and safety of oral tranexamic acid in Melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Age between 18 - 65 years old ; Symmetric distribution of melasma ; Informed consent.
Exclusion criteria : Usage of hydroquinone ,topical or oral retinoids ,topical corticosteroid ,alfa hydroxyl acids or other drugs effective to skin pigmentation 3 months prior to the study ; Usage of peeling agents 3 months prior to the study ; Laser therapy 3 months prior to the study ; Sunburn , high exposure to sunlight or solarium usage 3 months prior to the study ; Usage of oral contraceptive concurrently ; Personal or familial history of vitiligo or other pigmentation disorders ; Suspected Hypersensitivity to hydroquinone or trenaxemic acid ; Pregnancy or lactation ; History of ischemic heart disease or cerebrovascular disease ; History of coagulation disorders or deep vein thrombosis ; Usage of aspirin or Plavix.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
At the final visit , patients will be asked to characterize their overall satisfaction graded on a quartile scale as follows : complete satisfaction , moderate satisfaction , fair satisfaction and dissatisfaction.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in Research Committee of Tehran University of Medical Sciences
Street address
Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences , Ghods intersection , Keshavarz blvd.
City
Tehran
Postal code
1417653761
Approval date
2013-08-26, 1392/06/04
Ethics committee reference number
91/د/130/3630
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Improvement of pigmentation
Timepoint
Before the intervention, 1 and 3 months after the intervention and three months after discontinuation intervention
Method of measurement
MASI Score , Digital photography , Patient satisfaction
Secondary outcomes
1
Description
Gastrointestinal complications
Timepoint
Before the intervention, 1 and 3 months after the intervention and three months after discontinuation intervention
Method of measurement
Question of patients
2
Description
Reduce menstrual bleeding
Timepoint
Before the intervention, 1 and 3 months after the intervention and three months after discontinuation intervention
Method of measurement
Question of patients
Intervention groups
1
Description
Intervention group : Tranexamic acid , 250 mg capsules , 3 times a day with hydroquinone 4% cream every night for 3 months.
Category
Treatment - Drugs
2
Description
Control group : Hydroquinone 4% cream every night for 3 months .
Vice Chancellor for Reasearch of Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Central Construction of Tehran University of Medical Sciences , Ghods intersection , Keshavarz blvd. Vice chancellor for research of Tehran University of Medical Sciences
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 Reasearch of Tehran University of Medical Sciences