Comparison of efficacy and safety of topical Tranexamic Acid with and without using non-ablative fractional Erbium glass in patients with melasma refering to Razi Hospital
laser 1540nm for treatment of melasma in patients referred to Razi hospital
Melasma is a common problem,treatment of melasma is a real challenge due to its frequent recurrence and aggravation even during or after treatment. no single treatment has been proven to be the most effective.therfore,combination treatment using several possible modalities has been preferred.in this study we analyse efficacy of topical tranexamic acid with and without erbium glass laser 1540nm in patients with melasma.an important inclusion criteria is symmetric melasma.group 1 uses topical tranexamic acid and group 2 in addition of use topical tranexamic acid, laser monthly.every half of each face using table of random number place in a group.A blind dermatologist assesses patient using Melasma Area and Severity Index and his clinical assess,also patients' satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011626047N1
Registration date:2016-04-24, 1395/02/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-24, 1395/02/05
Registrant information
Name
Zahra Shadlou
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 0513
Email address
zshadlou@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of topical Tranexamic Acid with and without using non-ablative fractional Erbium glass in patients with melasma refering to Razi Hospital
laser 1540nm for treatment of melasma in patients referred to Razi hospital
Public title
The efficacy of topical Tranexamic Acid with and without using laser laser for treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: 18-65 years; symmetrical melasma in both half of the face; patients' satisfaction; skin type 1-5
exclusion criteria: use hidroquinone, topical and oral retinoid, topical steroid, alfa hydroxy acids and other drugs effect on pigmentation in past 4 weeks; use Oral Conterseptive Pill; chemical peeling,microderm abration, dermabratin or laser in past 3 months; history of past sensitivity to tranexamic acid; pregnancy; lactation; history ischemic or hemorrahgic events of coronal or cerebral artries
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Science
Street address
Room105, 5th floor, Centeral building Tehran University of Medical Science, GHods avenu, Keshvarz boulevard, Tehran
City
Tehran
Postal code
1417653761
Approval date
2016-02-07, 1394/11/18
Ethics committee reference number
IR.TUMS.REC. 1394.1905
Health conditions studied
1
Description of health condition studied
melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
pigmantation
Timepoint
before intervention,at the end of intervention,1 mouth and 3 mouths after end of intervention
Method of measurement
modified Melasma Area and Severity Index(mMASI) score,digital photography,patient satisfaction(questionnaire),physician assessment
Secondary outcomes
1
Description
topical advers effects
Timepoint
every month in intervention period and end of intervention
Method of measurement
questionnaire and observation
Intervention groups
1
Description
intervention group:
topical tranexamic acid 5% in cold cream 2 times in a day withfractional erbium glass 1540nm(Sturlux) monthly
Category
Other
2
Description
control group:
topical tranexamic acid 5% in cold cream 2 times in a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Zahra Shadlou
Street address
Razi Hospital, Vahdat eslami Square, Vahdat eslami Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Science
Full name of responsible person
Dr Masud Yunesian
Street address
Central building of Tehran University of Medical Science, Keshavarz Boulvard, Tehran
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,Tehran University of Medical Science
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
Tehran University of Medical Science
Full name of responsible person
Dr Zahra Shadlou
Position
Skin disease Resident
Other areas of specialty/work
Street address
Razi Hospital
City
Tehran
Postal code
1199663911
Phone
+98 21 5563 0669
Fax
Email
zshadlou@razi.tums.ac.ir; dr.z.shadlou@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Amir houshang Ehsani
Position
Assotiate Professor
Other areas of specialty/work
Street address
Razi Hospital
City
Tehran
Postal code
1199663911
Phone
+98 21 5563 0669
Fax
Email
ehsanih@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Zahra Shadlou
Position
Skin disease Resident
Other areas of specialty/work
Street address
Razi Hospital
City
Tehran
Postal code
1199663911
Phone
+98 21 5563 0669
Fax
Email
zshadlou@razi.tums.ac.ir; dr.z.shadlou@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)