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

February 28, 2026 updated by: Rana Sameer Mohamed, Assiut University

Evaluation of the Efficacy and Safety of Oral Tranexamic Acid Combined With Glutathione-assisted Microneedling Versus Each Therapy Alone in the Treatment of Melasma

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Melasma is a chronic, acquired, frequent relapsing and cosmetically disfiguring disorder of hypermelanosis, characterized by light to dark brown hyperpigmentation mostly in sun exposed areas, affected predominantly middle aged females particularly those with darker skin, multiple factors have been postulated to involve in the etiology and pathogenesis of melasma like ; pregnancy, genetics, sun exposure and skin inflammation .Melasma significantly affect quality of life and self-steem of the patients due to its disfigurity appearance.

Although melasma has been widely studied, the treatment still met with difficulty, various therapeutic approaches were tried in treatment of melasma including topical and systemic treatments, chemical peeling, and laser therapy, however none have shown sustained results with incomplete clearance and frequent recurrences.

There has been interest lately in oral medications like tranexamic acid (TXA ) to improve melasma, oral TXA is a synthetic derivative of the amino acid lysine, lysine is an antifibrinolytic agent, procoagulant and approved by FDA for the treatment of cyclic heavy menstrual bleeding, oral TRX acid has been used off-label in dermatology for treatment of hyperpigmentation disorders

.

Also glutathione(GSH) is an option in treatment of melasma, GSH is endogenous tripeptide composed of cysteine, glycine, and glutamate, and serves as a key component of the cellular antioxidant defenCe system by scavenging free radicals and reducing oxidative stress it is considered as skin lightening agent, its major mechanism by inhibition of tyrosinase, tyrosinase inhibition effect indirectly as anti-oxidant agent.

Microneedling is a well-known and established approach for drug delivery applied to treat various skin issues, including melasma. Existing studies indicate that microneedling is an effective adjuvant topical therapy for melasma.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: microneedling
with one ml of topical glutathione will be done in group A and B, three consecutive sessions, will be performed by derma pen with 36 needles head, will adjusted 1.5 mm needle length and will moved on stretched skin in four directions several times till erythema and pinpoint developed before and after topical application of GTH.
Drug: Oral tranexamic acid
The patient will take oral tranexamic acid 250mg twice daily for 3 months
Other: Glutathione
investigators will use topical GSH solution in assist with microneedling to treat melasma
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.
Device: microneedling
with one ml of topical glutathione will be done in group A and B, three consecutive sessions, will be performed by derma pen with 36 needles head, will adjusted 1.5 mm needle length and will moved on stretched skin in four directions several times till erythema and pinpoint developed before and after topical application of GTH.
Other: Glutathione
investigators will use topical GSH solution in assist with microneedling to treat melasma
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.
Drug: Oral tranexamic acid
The patient will take oral tranexamic acid 250mg twice daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
compare reduction of Melasma Area and Severity Index (MASI) score in any treatment modalities
Time Frame: From baseline to 12 weeks
From baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
identify patient's satisfaction by Patient Self Assessment
Time Frame: from baseline to 3 months after treatment
from baseline to 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 28, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oral TXA & GSH in melasma

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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