Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT05236569

Collaborator

(none)

Enrollment

Location

Arms

3.9

Actual Duration (Months)

8.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Melasma	Drug: Tranexamic acid injection Drug: Injection Water	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tranexamic acid The intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally.	Drug: Tranexamic acid injection The tranexamic acid injection was given intradermally to the facial skin
Placebo Comparator: Placebo The placebo was 1 ml of 0.9% normal saline which was given intradermally.	Drug: Injection Water The 0.9% normal saline injection was given intradermally to the facial skin

Arm

Intervention/Treatment

Experimental: Tranexamic acid

The intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally.

Drug: Tranexamic acid injection

The tranexamic acid injection was given intradermally to the facial skin

Placebo Comparator: Placebo

The placebo was 1 ml of 0.9% normal saline which was given intradermally.

Drug: Injection Water

The 0.9% normal saline injection was given intradermally to the facial skin

Outcome Measures

Primary Outcome Measures

Modified Melasma Area and Severity Index (mMASI) score [12 weeks]
Reduction of mMASI score
Erythema Index [12 weeks]
Reduction of erythema index
Melanin Index [12 weeks]
Reduction of melanin index

Secondary Outcome Measures

Side effects [12 weeks]
Incidence of side effects
Subject's satisfaction [12 weeks]
Satisfaction towards the treatment's results measured by patient global assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital	Jakarta	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vashty Amanda Hosfiar, MD, Indonesia University

ClinicalTrials.gov Identifier:

NCT05236569

Other Study ID Numbers:

20-11-1376

First Posted:

Feb 11, 2022

Last Update Posted:

Feb 11, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Vashty Amanda Hosfiar, MD, Indonesia University

melasma

tranexamic acid

modified melasma area and severity index

melanin index

erythema index

Additional relevant MeSH terms:

Melanosis

Tranexamic Acid

Study Results

No Results Posted as of Feb 11, 2022