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Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma
Plain-language guide to NCT07448415: phase 2, phase 3 randomized trial of Glutathione, 42 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07448415
- Phase
- phase 2, phase 3
- Status
- not yet recruiting
- Start
- 2026-02
- Completion (planned or actual)
- 2027-02
- Participants
- 42 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Melasma
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2, phase 3) is built around Glutathione.
It had three arms (groups): Combined TXA + GSH-assisted microneedling arm (active comparator), GSH-assisted microneedling arm (active comparator) and Oral TXA (active comparator).
Will include 14 patients, they will be treated by microneedling assisted with glutathione every 4 weeks for a maximum of 3 months.
The registry classes the interventions as device, drug and other.
More on the Plan
Microneedling is a well-known and established approach for drug delivery applied to treat various skin issues, including melasma.
Who Took Part
The registry lists 42 planned participants were the target.
It was open to women only aged from 18 years up to 50 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: • female patients. 18/50 years old.
The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: history of any bleeding,; clotting disorder; using anticoagulants.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Glutathione group and the comparison group should start out alike.
The Glutathione group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Glutathione study: the participants and staff both knew the treatment.
It started in 2026-02 with completion listed for 2027-02.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 1 secondary outcome, for example identify patient's satisfaction by Patient Self Assessment.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3, randomized trial of Glutathione in 42 people.
Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Glutathione compound page, all human trials.
Our Notes on the Compound
Glutathione: The body's main antioxidant.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.