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NCT Number: NCT07448415

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

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

microneedling

Device

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.

oral tranexamic acid

Drug

The patient will take oral tranexamic acid 250mg twice daily for 3 months

Glutathione

Other

investigators will use topical GSH solution in assist with microneedling to treat melasma

Primary outcomes

  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. identify patient's satisfaction by Patient Self Assessment

    Time frame: from baseline to 3 months after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Rana Sameer, Postgraduate student

CONTACT

[email protected]

+201064123736

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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