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Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma
Sponsor: Thammasat University
Summary
This study compares the effectiveness of two oral medications-melatonin and tranexamic acid -in treating melasma, a common skin condition that causes dark facial patches. Participants will be randomly assigned to receive either melatonin, tranexamic acid, or a placebo once daily at bedtime for 12 weeks. During this treatment phase, all participants will also apply a broad-spectrum sunscreen and a base cream. After 12 weeks, participants will stop the oral medication but continue using the sunscreen and base cream for an additional 12 weeks to assess recurrence of melasma. The study evaluates improvement in skin pigmentation, recurrence after treatment cessation, quality of life, and patient satisfaction. This clinical trial will be conducted at Benchakitti Park Hospital, Bangkok, Thailand, and will enroll 75 adult participants.
Official title: Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma : A Comparative, Randomized, Controlled Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2024-11-12
Completion Date
2025-11-06
Last Updated
2025-06-24
Healthy Volunteers
No
Conditions
Interventions
Tranexamic Acid (TXA)
500 mg oral tranexamic acid (Transamin®), taken once daily at bedtime for 12 weeks.
melatonin (Circadin)
2 mg oral melatonin (Circadin®), taken once daily at bedtime for 12 weeks.
Placebo
Placebo capsule identical in appearance, taken once daily at bedtime for 12 weeks.
Locations (1)
Benchakitti Park Hospital
Bangkok, Bangkok, Thailand