In this evaluation, 30 patients with melasma clinically diagnosed are entered to the study. This study is performed as double- blind randomized clinical trial by liposomal tranexamic acid on one side of the face and conventional Hydroquinone 4% on another side. Liposomal form will be prepared by fusion method. The size of these liposomes will be determined by the Particle Size Analyzer of Malvern device and surrounding percentage will be carried out by the direct method after separation of not encapsulated tranexamic acid by dialysis. Amount of tranexamic acid will be determined by spectrophotometry. Informed consent before entering the study will be obtained from all patients. In the first visit, severity of disease is recorded by Melasma Area and Severity Index (MASI). Then each patient two will be given two separate package containing form liposomal tranexamic acid and forms Hydroquinone 4% to the similar tubes with the numbers 1 and 2. The patients will be trained to use certain amount of either drug at nights. Sunscreen will be used daily every three hours for 12 weeks. Furthermore MASI will be recorded in each side of the face monthly and after one month of the last visit. All the patients are examined by one dermatologist during treatment course.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403173862N10
Registration date:2014-04-15, 1393/01/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-15, 1393/01/26
Registrant information
Name
Farahzad Jababri Azad
Name of organization / entity
Mashahd University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 6626
Email address
banihashemim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nano Technology Research Center,Mashhad University of Medical Sciences
Expected recruitment start date
2011-08-03, 1390/05/12
Expected recruitment end date
2014-05-02, 1393/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutic effects of liposomal tranexamic acid and Hydroquinone on melasma patients
Public title
Comparison the therapeutic effects of liposomal tranexamic acid form and conventional form of Hydroquinone on melasma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: clinically diagnosed melisma patients, age more than 18 years old.
Exclusion criteria: pregnancy and breast feeding, simultaneous hormonal disease, drug use including anti barbiturate drugs, recent hormonal and corticosteroids treatments, patients who treated by bleaching therapy on the last four months, patients underwent laser during the last six month, patients who don’t refer on follow up periods, any side effects which canceled the treatment.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study is performed as double blind, as the patients and the physicians of disease severity are not alert about which therapeutic form will be used in each side of the face.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
910183
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Melasma
Primary outcomes
1
Description
Improvement of pigmentation
Timepoint
Monthly untill the end of 12 weeks
Method of measurement
Melasma Area and Severity Index
Secondary outcomes
1
Description
Melasma severity
Timepoint
Comparison melasma severity in baseline and terminal of 3 months treatment course
Method of measurement
Melasma Area and Severity Index
Intervention groups
1
Description
Control group: hidroqinone cream 2%, one time/day on the lesion of one side of face
Category
Treatment - Drugs
2
Description
Intervention group: liposomal tranexamic acid cream 1 time/day on the lesion of one side of face
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital, Mashhad University of Medical Sciences
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), daneshgah 16, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Asma Jabari
Position
Medical student
Other areas of specialty/work
Street address
Ghaem hospital, Ahmad Abad street
City
Mashhad
Postal code
Phone
+98 51 1864 2637
Fax
Email
asma_v_jabari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahnaz banihashemi, Dr Mahmoud Reza Jafari, Dr Naghmeh Zabolinejad
Position
Associate professor of dermatology, Professor of Pharmasutics, Assistant professor of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Ghaem hospital, Ahmad Abad street