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Efficacy and safety of oral tranexamic acid in Melasma

Efficacy and safety of oral tranexamic acid in Melasema

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013091914715N1
Enrollment
100
Registered
2014-01-01
Start date
2014-01-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma. Chloasma

Interventions

Intervention 1: Intervention group : Tranexamic acid , 250 mg capsules , 3 times a day with hydroquinone 4% cream every night for 3 months. Intervention 2: Control group : Hydroquinone 4% cream ev
Treatment - Drugs
Intervention group : Tranexamic acid , 250 mg capsules , 3 times a day with hydroquinone 4% cream every night for 3 months.
Control group : Hydroquinone 4% cream every night for 3 months .

Sponsors

Vice Chancellor for Reasearch of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria : Age between 18 - 65 years old ; Symmetric distribution of melasma ; Informed consent. Exclusion criteria : Usage of hydroquinone ,topical or oral retinoids ,topical corticosteroid ,alfa hydroxyl acids or other drugs effective to skin pigmentation 3 months prior to the study ; Usage of peeling agents 3 months prior to the study ; Laser therapy 3 months prior to the study ; Sunburn , high exposure to sunlight or solarium usage 3 months prior to the study ; Usage of oral contraceptive concurrently ; Personal or familial history of vitiligo or other pigmentation disorders ; Suspected Hypersensitivity to hydroquinone or trenaxemic acid ; Pregnancy or lactation ; History of ischemic heart disease or cerebrovascular disease ; History of coagulation disorders or deep vein thrombosis ; Usage of aspirin or Plavix.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Improvement of pigmentation. Timepoint: Before the intervention, 1 and 3 months after the intervention and three months after discontinuation intervention. Method of measurement: MASI Score , Digital photography , Patient satisfaction.

Secondary

MeasureTime frame
Gastrointestinal complications. Timepoint: Before the intervention, 1 and 3 months after the intervention and three months after discontinuation intervention. Method of measurement: Question of patients.;Reduce menstrual bleeding. Timepoint: Before the intervention, 1 and 3 months after the intervention and three months after discontinuation intervention. Method of measurement: Question of patients.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Afsane Ghayoumi

Tehran University of Medical Sciences

afsanehghayoumi@yahoo.com; a_ghayoumi@razi.tums.ac.ir+98 21 5563 0669

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026