CompletedNot Applicable

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

Indonesia34 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Modified Melasma Area and Severity Index (mMASI) score

Timeframe: 12 weeks

Erythema Index

Timeframe: 12 weeks

Melanin Index

Timeframe: 12 weeks

Trial details

NCT IDNCT05236569

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-31

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