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Trial · Interventional

Not yet recruitingPhase 2/3Registry data

Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma

NCTNCT07448415 (opens ClinicalTrials.gov in a new tab)Other idOral TXA & GSH in melasma
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 2/3
Enrollment
42 participants (estimated)
Sponsor
Assiut University · Other
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
Feb 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Apr 2027 (estimated)
First posted
4 Mar 2026
Last update posted
4 Mar 2026
Conditions
Melasma

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 2/3

    Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma

    NCT07448415

    est. Feb 2026 to est. Apr 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

In this study, the investigators evaluate the potential efficacy of TXA alone and microneedling assisted with glutathione alone versus combination of oral tranexamic acid and glutathione-assisted microneedling in the treatment of melasma

Interventions

  • microneedlingDevice
  • Oral tranexamic acidDrug
  • GlutathioneOther

Arms3

  • Active comparator

    Combined TXA + GSH-assisted microneedling arm

    will include 14 patients with facial melasma. They will be treated by combined * oral tranexamic acid (250 mg) twice a day for 3 months * microneedling assisted with glutathione every 4 weeks for a maximum of 3 months.

  • Active comparator

    GSH-assisted microneedling arm

    will include 14 patients, they will be treated by microneedling assisted with glutathione every 4 weeks for a maximum of 3 months.

  • Active comparator

    Oral TXA

    will include 14 patients, they will be treated by * oral TXA alone 250mg twice daily for a maximum of 3 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. compare reduction of Melasma Area and Severity Index (MASI) score in any treatment modalities

    Time frame · From baseline to 12 weeks

Secondary outcomes(1)

  1. identify patient's satisfaction by Patient Self Assessment

    Time frame · from baseline to 3 months after treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * • female patients * 18/50 years old * facial melasma Exclusion Criteria: * pregnancy * lactation. * History of any bleeding, * clotting disorder * using anticoagulants * Chronic systemic diseases * patients with history of atypical parkinsonism * use of neuroleptics, * history of a seizure * drug addiction * Patients with signs of facial inflammation or infection. * Patients on oral contraceptive pills * patients with hormonal replacement therapy * patients on isotretinoin at the time of the study or during the past 6 months.

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