To compare the efficacy of intralesional tranexamic acid and topical 4% hydroquinone in the treatment of melasma
Design
Comparative prospective study
Settings and conduct
Study was conducted at the Dermatology Department, Pak Emirates Military Hospital Rawalpindi, Pakistan from 16th October 2018 to 16th April 2019.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female patients of age 18-50 years with melasma for 6 months and not received any treatment in last 3 months. Exclusion Criteria: History of discoid lupus erythematosus, lichen planus on medical record, pregnancy, lactating mothers, anemia (Hb<10) and patients on oral contraceptive pills or hormonal therapy.
Intervention groups
Patients in Group A received weekly intradermal injections of 0.5 ml tranexamic acid in 0.5 ml normal saline (50 mg/ml) into the melasma lesion at 1 cm intervals using a sterile insulin syringe. Patients in Group B were given a topical hydroquinone 4% cream to apply to the relevant area at night for a period of 12 weeks. Follow up was done at 4 weekly intervals for 12 weeks. After 12 weeks final response was assessed. All patients were called for follow up and efficacy was evaluated on the basis of fall in MASI score from base line.
Main outcome variables
Efficacy was evaluated on the basis of fall in MASI score from base line.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220709055422N1
Registration date:2022-07-17, 1401/04/26
Registration timing:retrospective
Last update:2022-07-17, 1401/04/26
Update count:0
Registration date
2022-07-17, 1401/04/26
Registrant information
Name
anjum muhammad
Name of organization / entity
Pak-Emirates Military Hospital Rawalpindi
Country
Pakistan
Phone
+92 334 9112468
Email address
anjumhassan87@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-16, 1397/07/24
Expected recruitment end date
2018-11-16, 1397/08/25
Actual recruitment start date
2018-10-16, 1397/07/24
Actual recruitment end date
2018-10-27, 1397/08/05
Trial completion date
2019-04-16, 1398/01/27
Scientific title
Comparison of Efficacy of Intralesional Tranexamic Acid Versus Topical 4% Hydroquinone in Treating Melasma
Public title
Efficacy of Tranexamic Acid Versus Topical 4% Hydroquinone in Melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients suffering from melasma
Exclusion criteria:
history of discoid lupus erythematosus
pregnancy
lactation
anemia
oral contraceptives or hormone replacement therapy
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
290
Actual sample size reached:
290
Randomization (investigator's opinion)
Randomized
Randomization description
By using block design, we randomized the data. Randomization was 1:1 for Group A and Group B, i.e. each upcoming individual was included in the next group; this randomization was supervised by another clinician. Sample size for Group A (intralesional tranexamic acid) was 145 while sample size for Group B (topical 4% hydroquinone) was 145
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pak-Emirates Military Hospital Rawalpindi Ethical and Institutional Review Committee
Street address
PEMH Hospital Rawalpindi Cantonment
City
Rawalpindi
Postal code
46000
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
EC/A/28
Health conditions studied
1
Description of health condition studied
Melasma .
ICD-10 code
L81.1
ICD-10 code description
L81.1 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes. The 2022 edition of ICD-10-CM L81.1 became effective on October 1, 2021.This is the American ICD-10-CM version of L81.1 - other international
Primary outcomes
1
Description
Efficacy was evaluated on the basis of fall in MASI score for Melasma from base line
Timepoint
Interventions were Offred for a period of 12 weeks. Follow up was done at 4 weekly intervals for 12 weeks. After 12 weeks final response was assessed. All patients were called for follow up and efficacy was evaluated on the basis of fall in MASI score from base line
Method of measurement
MASI score was measured by a trained physician on each visit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients received weekly intradermal injections of 0.5 ml Tranexamic acid in 0.5 ml normal saline (50 mg/ml) into the melasma lesion at 1 cm intervals using a sterile insulin syringe.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in intervention Group 2 were given a topical hydroquinone 4% cream to apply to the relevant area at night for a period of 12 weeks. Follow up was done at 4 weekly intervals for 12 weeks. After 12 weeks final response was assessed. All patients were called for follow up and efficacy was evaluated on the basis of fall in MASI score from base line. Patients who lost to follow up were contacted through their contact numbers and were reminded for their follow up visit.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pak-Emirates Military Hospital Rawalpindi Ethical and Institutional Review Committee
Full name of responsible person
Dr Muhammad Rizwan
Street address
PEMH Hospital Rawalpindi Cantonment
City
Rawalpindi
Postal code
46000
Phone
+92 333 5373829
Email
rizwan_rawalian2000@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pak-Emirates Military Hospital Rawalpindi
Full name of responsible person
Ayesha Akhtar
Street address
PEMH Hospital Rawalpindi Cantonment
City
Rawalpindi
Postal code
46000
Phone
+92 321 7324093
Email
suhailaisha1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Pak-Emirates Military Hospital Rawalpindi
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
Pak-Emirates Military Hospital Rawalpindi
Full name of responsible person
Dr Muhammad Rizwan
Position
Consultant Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
PEMH Hospital Rawalpindi Cantonment
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 5373829
Email
rizwan_rawalian2000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
PEMH Rawalpindi
Full name of responsible person
Dr Muhammad Rizwan
Position
Consultant Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
PEMH Hospital Rawalpindi Cantonment
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 5373829
Email
rizwan_rawalian2000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
PEMH Rawalpindi
Full name of responsible person
Dr Muhammad Anjum
Position
Resident Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
PEMH Hospital Rawalpindi Cantonment
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 334 9112468
Email
anjumhassan87@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available