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A Comparative Study of the Efficacy of 0.5% Melatonin Cream and 3% Tranexamic Acid in the Treatment of Melasma

A Comparative Study of the Efficacy of 0.5% Melatonin Cream and 3% Tranexamic Acid in the Treatment of Melasma

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260623011
Enrollment
20
Registered
2026-06-23
Start date
2025-12-08
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

mild to severe melasma Melasma, Fitzpatrick skin types III to V, Hemifacial mMASI score

Interventions

Applied twice daily (morning and evening) in a thin, even layer on the entire face. Approximately 0.5 grams of cream (equivalent to one fingertip) will be applied to the face in the morning and evenin
Experimental Drug,Experimental Drug
0.3% Melatonin cream ,3% Tranexamic acid

Sponsors

Mae Fah Luang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1.Adults aged 20 to 50 years with Fitzpatrick skin types III to V. 2.Diagnosed with mild to severe melasma using the Hemifacial mMASI score. 3.Subject will be provided with written and verbal informed consent. 4.Subject who is willing to follow through the instructions to be studied and is willing to do follow up visits

Exclusion criteria

Exclusion criteria: 1.Use of systemic or topical depigmenting agents within 4 weeks. 2.History of hypersensitivity to systemic or topical melatonin or tranexamic acid. 3.Subject is pregnant, lactating or willing to be pregnant during the study. 4.Subject who is taking combined oral contraceptives or vitamin A derivatives. 5.Subjects with occupations or lifestyles involving prolonged sun exposure. 6.Subject has any condition or pathology on the skin that might affect the study, e.g., dermitis or any infection on the skin. 7.Subject with photosensitive pathology, e.g. thyroid disease, diabetes mellitus, photosensitive dermatoses, any liver or kidney disease. 8.Subjects who are on hormone therapy. 9.Subject who is taking drug that can casue photosensitivity such as doxycycline or co-trimoxazole. 10.Subject who is unable to communicate with the researcher which may be due to language problems, any neurological or mental disease. 11.Subject who is unreliable for the study due to excessive alcohol intake or any drug abuse.

Design outcomes

Primary

MeasureTime frame
Reduction of melasma 3 months from the start hemifacial mMASI score

Secondary

MeasureTime frame
reduction of melasma 3 months from the start Maxameter

Countries

Thailand

Contacts

Public ContactZaw Latt Ye Naung

Mae Fah Luang University

6652001038@lamduan.mfu.ac.th0617049695

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026