NCT07448415

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Melasma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-02-01
• Completion: 2027-04-01
• First posted: 2026-03-04
• Last updated: 2026-03-04