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Completed

NCT Number: NCT05236569

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

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.

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic acid injection

Drug

The tranexamic acid injection was given intradermally to the facial skin

Injection Water

Drug

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

Primary outcomes

  1. Modified Melasma Area and Severity Index (mMASI) score

    Time frame: 12 weeks

    Reduction of mMASI score

  2. Erythema Index

    Time frame: 12 weeks

    Reduction of erythema index

  3. Melanin Index

    Time frame: 12 weeks

    Reduction of melanin index

Secondary outcomes

  1. Side effects

    Time frame: 12 weeks

    Incidence of side effects

  2. Subject's satisfaction

    Time frame: 12 weeks

    Satisfaction towards the treatment's results measured by patient global assessment

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2022
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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