Back to resultsEffectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V
Primary Purpose
Melasma
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Tranexamic acid injection
Injection Water
Sponsored by
About this trial
This is an interventional treatment trial for Melasma focused on measuring melasma, tranexamic acid, modified melasma area and severity index, melanin index, erythema index
Eligibility Criteria
Inclusion Criteria:
- aged 18 to 60 years old
- Fitzpatrick skin type IV - V
- diagnosed with melasma
Exclusion Criteria:
- pregnancy and breastfeeding
- use of oral contraceptives within six months
- use of topical or systemic melasma therapy within two weeks
- history of superficial peeling within four weeks
- history of dermabrasion within six months
- use of photosensitizer drugs
- history of thrombosis or currently using antithrombotic or anticoagulant drugs
- history of TA allergy
- experiencing any COVID-19 symptoms
Sites / Locations
- Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic acid
Placebo
Arm Description
The intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally.
The placebo was 1 ml of 0.9% normal saline which was given intradermally.
Outcomes
Primary Outcome Measures
Modified Melasma Area and Severity Index (mMASI) score
Reduction of mMASI score
Erythema Index
Reduction of erythema index
Melanin Index
Reduction of melanin index
Secondary Outcome Measures
Side effects
Incidence of side effects
Subject's satisfaction
Satisfaction towards the treatment's results measured by patient global assessment
Full Information
NCT ID
NCT05236569
First Posted
January 28, 2022
Last Updated
February 9, 2022
Sponsor
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT05236569
Brief Title
Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V
Official Title
Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V: A Double-Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A double-blind, randomized, split-face controlled trial of 34 female patients with melasma was conducted. All subject were randomized to receive either intradermal tranexamic acid or placebo injection on the right or the left side of their face.
Detailed Description
All subject were randomized to receive either 10 mg of intradermal tranexamic acid or placebo injection on the right or the left side of their face.
The primary outcome was improvement of melasma lesions assessed by modified Melasma Area and Severity Index (mMASI) score and mexameter examination which includes Melanin Index (MI) and Erythema Index (EI).
Measurements were done at baseline and every two weeks for twelve weeks. Additionally, side effects of therapy and subjects' satisfactory assessment with patient global assessment (PtGA) were also documented.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
melasma, tranexamic acid, modified melasma area and severity index, melanin index, erythema index
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible subjects were randomized to receive either 10 mg of intradermal tranexamic acid injection or placebo on one side of the face with 1:1 ratio. The allocation sequence was generated with a computer by an analyst.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The allocation sequence was generated with a computer by an analyst. The allocation sequence was concealed from the investigators, care provider, outcomes assessor, and subjects.
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid
Arm Type
Experimental
Arm Description
The intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo was 1 ml of 0.9% normal saline which was given intradermally.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Intervention Description
The tranexamic acid injection was given intradermally to the facial skin
Intervention Type
Drug
Intervention Name(s)
Injection Water
Intervention Description
The 0.9% normal saline injection was given intradermally to the facial skin
Primary Outcome Measure Information:
Title
Modified Melasma Area and Severity Index (mMASI) score
Description
Reduction of mMASI score
Time Frame
12 weeks
Title
Erythema Index
Description
Reduction of erythema index
Time Frame
12 weeks
Title
Melanin Index
Description
Reduction of melanin index
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Side effects
Description
Incidence of side effects
Time Frame
12 weeks
Title
Subject's satisfaction
Description
Satisfaction towards the treatment's results measured by patient global assessment
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged 18 to 60 years old
Fitzpatrick skin type IV - V
diagnosed with melasma
Exclusion Criteria:
pregnancy and breastfeeding
use of oral contraceptives within six months
use of topical or systemic melasma therapy within two weeks
history of superficial peeling within four weeks
history of dermabrasion within six months
use of photosensitizer drugs
history of thrombosis or currently using antithrombotic or anticoagulant drugs
history of TA allergy
experiencing any COVID-19 symptoms
Facility Information:
Facility Name
Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V
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