Evaluation of the effectiveness of microneedling with Tranexamic acid in comparison with microneedling with PRP in the treatment of Melasma
Design
Parallel group randomized clinical trial, single-blinded with control group, 2nd phase on 23 patients. Randomization was carried out using coin toss method
Settings and conduct
The current study will be conducted on patients referred to the Dermatology clinic of Imam Khomeini Hospital of Ahvaz. In each session, Microneedling is done for one side of the face with PRP and with Tranexamic acid for the other side. The patient will not be aware of what medicine is injected for each side of her face, but the therapist is aware of this (single-blinded)
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 to 50 years old women with symmetric and bilateral facial Melasma.
Exclusion criteria: Pregnant women and breastfeeding mothers, Having any history of coagulation disorders and thrombotic problems, Using anticoagulant and anticonvulsant drugs, Being allergic to study drugs and topical lidocaine, History of Melasma treatment during the past month, Active facial Herpes simplex lesions, Facial wart
Intervention groups
Intervention group 1: Performing Microneedling to a depth of 1.5 to 2 mm of the skin of one side of the face of the person under study with Tranexamic acid on 3 occasions with an interval of 3 weeks (random selection)
Intervention group 2: Performing Microneedling to a depth of 1.5 to 2 mm of the skin of the other side of the face of the person under study with PRP on 3 occasions with an interval of 3 weeks (random selection)
Main outcome variables
Melasma area and severeity index score (MASI SCORE)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221025056287N1
Registration date:2022-12-09, 1401/09/18
Registration timing:registered_while_recruiting
Last update:2022-12-09, 1401/09/18
Update count:0
Registration date
2022-12-09, 1401/09/18
Registrant information
Name
Havva Hajati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4282 9423
Email address
hajati.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-31, 1401/08/09
Expected recruitment end date
2022-12-30, 1401/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of microneedling with Tranexamic acid in comparison with microneedling with PRP in the treatment of melasma
Public title
Comparison of microneedling with Tranexamic acid and PRP in treatment of Melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-50 years old women with Melasma
Symmetrical and bilateral facial Melasma
Exclusion criteria:
Pregnant women
Breastfeeding mothers
Use of anticoagulants and anticonvulsants
Being allergic to the study drugs and topical lidocaine
History of Melasma treatment during the past month
Active Herpes simplex lesions on the face
Facial warts
Any history of coagulation disorders and thrombotic problems
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
23
More than 1 sample in each individual
Number of samples in each individual:
2
Right and left side of the face
Randomization (investigator's opinion)
Randomized
Randomization description
We have two treatment groups of A and B in this study. For randomization, microneedling with Tranexamic acid is considered for the right side of patient's face and microneedling with PRP for the left side in group A. The treatment method in group B will be the opposite. This means that the right side of patient's face will be treated by microneedling with PRP and the left side by microneedling with Tranexamic acid. The treatment method of A and B will be determined using coin toss method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is not aware of how the treatment is assigned to the right and left side of her face, but the therapist knows that. This method is that PRP and tranexamic acid are drawn in insulin syringes with the same appearance covered with adhesive medical tape, so that the therapist is aware of their contents, but the patient is not aware of the type of drug used on the right and left side of the face.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan Educational, Research and Treatment Center
Street address
Golestan Educational and Medical Center, Farvardin Ave, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2022-10-18, 1401/07/26
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.100
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81
ICD-10 code description
Other disorders of pigmentation
Primary outcomes
1
Description
Melasma measuring index (MASI SCORE)
Timepoint
At the beginning of the study, the second and third sessions and 3 weeks after the completion of treatment sessions.
Method of measurement
Taking photo of the face with camera
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: performing Microneedling to a depth of 1.5 to 2 mm of the skin using a 36-needle disposable cartridge with 200 mg Tranexamic acid in 3 times with an interval of 3 weeks on one side of the subject's face (random selection)
Category
Treatment - Other
2
Description
Intervention group 2: performing Microneedling to a depth of 1.5 to 2 mm of the skin using a 36-needle disposable cartridge with 2 cc PRP prepared by a standard PRP kit in 3 times with an interval of 3 weeks on one side of the subject's face (random selection)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
Nader Pazyar
Street address
Imam khomeini educational hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
Dr.Pazyar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Ground floor, Vice chanceller of research, Ahvaz Jundishapour University of Medical Sciences, Daneshgahi Town, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?