Comparison of Tranexamic acid (4mg/ml) Effect By Microneedling with Hydroquinone(4%) in the Treatment Of Melasma Patients.
Design
Patients are coded into two groups A and B with simple randomization. Group A, receives hydroquinone ointment. Group B, undergoing microneedling with tranexamic acid. Patients are evaluated at intervals of weeks 0-4-8-12 by a researcher who is not aware of the codes, and informations is provided to a person who is not aware of the codes for statistical analysis. so, this study is one blinded .
Settings and conduct
This study is done in Dermatology Clinic of Afzalipour Hospital of Kerman and researcher who evaluates patients and the person who analyzing the information are blind to the study groups.
Participants/Inclusion and exclusion criteria
All women with melasma who did not have bleeding disorders, Hormontherapy , topical treatment like hydroquinone in the past year,active herpes, facial wart and hypersensivity to tranexamic acid & hydroquinone.
Intervention groups
Group A: Patients with melasma who receive ointment hydroquinone.
Group B: Patients with melasma undergoing microneedling with tranexamic acid.
Main outcome variables
Demographic features(Age, Sex, Skin Type), Anatomic Location of melasma lesion and the rate of melasma lesions improvement at the end of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180811040761N1
Registration date:2018-09-05, 1397/06/14
Registration timing:retrospective
Last update:2018-09-05, 1397/06/14
Update count:0
Registration date
2018-09-05, 1397/06/14
Registrant information
Name
Hossein Mozayyeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8237
Email address
h.mozayyeni@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-14, 1397/05/23
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
2018-08-14, 1397/05/23
Actual recruitment end date
2018-08-23, 1397/06/01
Trial completion date
empty
Scientific title
Comparison of Transxamic Acid( 4mg/ml) Effects By Microneedling with Hydroquinone( 4%) Ointment in Treatment of Melasma Patients.
Public title
Effect Of Tranexamic acid By Microneedling in Melasma.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Women with Melasma.
Exclusion criteria:
Coagulopathy Disease.
Hormone Therapy.
Topical treatment, like Hydroquinone, in the past year.
Active Herpes.
Facial Wart.
Hypersensivity to Tranexamic acid & Hydroquinone.
Pregnancy and Lactation.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two groups A and B, randomly.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are assigned to two groups A and B, randomly, and researcher who visits and evaluates patients and Also, the person who analyzes the data is not aware of these codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences.
Melasma intensity based on MASI (Melasma Area Severity Index ) score.
Timepoint
(Melasma Area Severity Index ) MASI Score measurement at the beginning of the study and weeks 4, 8,12.
Method of measurement
Using the Melasma Area Severity Index (MASI) Score.
2
Description
The rate of recovery of melasma lesions based on the Patient Global Assessment.
Timepoint
The rate of improvement of melasma lesions at the end of the study was based on the Patient Global Assessment questionnaire.
Method of measurement
Patient Global Assessment Questionnaire.
3
Description
The rate of recovery of melasma lesions based on the Patient Global Assessment.
Timepoint
The rate of improvement of melasma lesions at the end of the study was based on the Physician Global Assessment questionnaire.
Method of measurement
Physician Global Assessment Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients, mounthly, undergo microneedling treatment with a concentration of 4 mg / ml of Tranexamic acid with Amiaemed, with a penetration depth of 1-1 / 2mm.
Category
Treatment - Drugs
2
Description
Control group: Patients treated with hydroquinone ointment 4% were treated for 3 months. Usage: nightly.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Afzalipour Hospital.
Full name of responsible person
Hossein mozayyeni
Street address
Emam Highway, Afzali Hospital, Dermatology group.
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8237
Email
h.mozayyeni@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
َAbbas Pardakhti
Street address
Ebne sina street, tahmaseb abad Intersection.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3857
Email
abpardakhty@kmu.ac.ir
Grant name
Annually grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hossein Mozayyeni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Emam Highway, afzali Hospital, Dermatology unit
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8237
Email
h.mozayyeni@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Simin Shamsi Meymandi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatopathology
Street address
Emam HighWay, Afzali Hospital, Dermatology Department
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 343222250
Email
meymandi_s@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hossein Mozayyeni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Emam Highway, Afzali Hospital, Dermatology group
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8237
Email
h.mozayyeni@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
At the end of study, a part of the data, including the Melasma Area Severity Index, the Patient Global Assessment and the Physician Global Assessment (Unidentifiable )will be published.
When the data will become available and for how long
2 months after the results are published
To whom data/document is available
Researchers in the field of university and industry