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Study of two oral treatments (melatonin and tranexamic acid) for treatment of melasma in women

A Comparative Study of the Efficacy of Oral Melatonin Versus Oral Tranexamic Acid in the Treatment of Melasma in Women: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108063
Enrollment
108
Registered
2026-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: L814- Other melanin hyperpigmentation

Interventions

Intervention1: Oral Melatonin: Oral Melatonin 3 mg once daily at bedtime will be given to all participants in this arm for 12 weeks. Control Intervention1: Oral Tranexamic acid: Oral Tranexamic acid 5

Sponsors

Datta Meghe Medical College, Nagpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-Female patients aged 25 50 year 2-Clinical diagnosis of facial melasma 3-Willingness to avoid other melasma treatments and provide written informed consent

Exclusion criteria

Exclusion criteria: 1- Current use of any systemic or topical melasma treatments. 2- Pregnancy or lactation. 3-History of systemic disorders like hepatic, renal, psychiatric or endocrine 4- Known hypersensitivity to melatonin or tranexamic acid.

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the change in modified Melasma Area and Severity Index (mMASI) score from baseline to 12 weeksTimepoint: At end of 12 weeks—

Secondary

MeasureTime frame
The secondary outcomes include improvement in patient s quality of life, clinical improvement, and occurrence of adverse effects.Timepoint: At end of 12 weeks—

Countries

India

Contacts

Public ContactDr Mugdha Vikas Kolambe
drsugat09@gmail.com9730974147

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026