|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
IRCT |
|
Last refreshed on:
|
22 February 2018 |
|
Main ID: |
IRCT2016011626047N1 |
|
Date of registration:
|
2016-04-24 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The efficacy of topical Tranexamic Acid with and without using laser laser for treatment of melasma
|
|
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 |
|
Date of first enrolment:
|
2016-02-20 |
|
Target sample size:
|
25 |
|
Recruitment status: |
Complete |
|
URL:
|
http://en.irct.ir/trial/21696 |
|
Study type:
|
interventional |
|
Study design:
|
Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
|
|
Phase:
|
3
|
|
|
Countries of recruitment
|
|
Iran (Islamic Republic of)
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr Zahra Shadlou
|
|
Address:
|
Razi Hospital
1199663911
Tehran
Iran (Islamic Republic of) |
|
Telephone:
|
+98 21 5563 0669 |
|
Email:
|
zshadlou@razi.tums.ac.ir; dr.z.shadlou@gmail.com |
|
Affiliation:
|
Tehran University of Medical Science |
|
|
Name:
|
Dr Amir houshang Ehsani
|
|
Address:
|
Razi Hospital
1199663911
Tehran
Iran (Islamic Republic of) |
|
Telephone:
|
+98 21 5563 0669 |
|
Email:
|
ehsanih@sina.tums.ac.ir |
|
Affiliation:
|
Tehran University of Medical Science |
| |
|
Key inclusion & exclusion criteria
|
Inclusion 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
Exclusion criteria:
Age minimum:
18 years
Age maximum:
65 years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chloasma
|
melasma.
Chloasma
|
|
Intervention(s)
|
Intervention 1: intervention group:
topical tranexamic acid 5% in cold cream 2 times in a day withfractional erbium glass 1540nm(Sturlux) monthly. Intervention 2: control group:
topical tranexamic acid 5% in cold cream 2 times in a day.
|
intervention group:
topical tranexamic acid 5% in cold cream 2 times in a day withfractional erbium glass 1540nm(Sturlux) monthly
|
control group:
topical tranexamic acid 5% in cold cream 2 times in a day
|
|
Treatment - Drugs
|
|
Primary Outcome(s)
|
|
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 Outcome(s)
|
|
Topical advers effects. Timepoint: every month in intervention period and end of intervention. Method of measurement: questionnaire and observation.
|
|
Source(s) of Monetary Support
|
|
Vice chancellor for research,Tehran University of Medical Science
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
ethics committee of Tehran University of Medical Science
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|