title: Topical 5% tranexamic acid for the treatment of melasma in Asians: a double-blind randomized controlled clinical trial.
abstract: BACKGROUND
  Topical tranexamic acid has been claimed to lighten melasma without serious adverse effects. However, controlled studies assessing the efficacy and safety of topical tranexamic acid (TA) for the treatment of melasma is limited.
  
  
  OBJECTIVE
  To assess in a double blind, randomized, prospective study, the efficacy of topical 5% tranexamic acid versus vehicle for treatment of melasma.
  
  
  METHODS
  Twenty-three women with bilateral epidermal melasma enrolled in a split-face trial lasting 12 weeks. Patients blindly applied topical 5% tranexamic acid and its vehicle, to the designated sides of the face twice daily in addition to the assigned sunscreen each morning. Pigmentation and erythema were measured objectively using a mexameter and Melasma Area and Severity Index (MASI), in addition to physician and patient global assessments.
  
  
  RESULTS
  Twenty-one patients completed the study. Eighteen out of twenty-three patients (78.2%) showed decrease in the melanin index on either or both sides of the face by the end of 12 weeks compared to baseline. The MASI scores were also significantly reduced on both tested sides. However, lightening of pigmentation induced by TA gel was neither superior nor different (p > 0.05) compared to its vehicle although erythema was significant on the TA-applied site (p < 0.05).
  
  
  CONCLUSIONS
  Although lightening of pigmentation was obtained, the results were not significant between the two regimens. However, topical TA produced erythema.
authors.affiliation: Phramongkutklao Hospital-Dermatology, Bangkok, Thailand. jewenator@gmail.com
authors.forename: Pinyapat
authors.initials: P
authors.lastname: Kanechorn Na Ayuthaya
authors.forename: Nucha
authors.initials: N
authors.lastname: Niumphradit
authors.forename: Aranya
authors.initials: A
authors.lastname: Manosroi
authors.forename: Artit
authors.initials: A
authors.lastname: Nakakes
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000933:Antifibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D057886:Bleaching Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004890:Erythema / Q000209:etiology; D005260:Female; D006801:Humans; D008548:Melanosis / Q000188:drug therapy*; D008875:Middle Aged; D012720:Severity of Illness Index; D014148:Tranexamic Acid / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000933:Antifibrinolytic Agents; D057886:Bleaching Agents; D014148:Tranexamic Acid