NCT07448415

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
10mo left

Started Feb 2026

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Feb 2026Apr 2027

Study Start

First participant enrolled

February 1, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 23, 2026

Last Update Submit

February 28, 2026

Conditions

Melasma

Keywords

Tranexamic acidglutathione

Outcome Measures

Primary Outcomes (1)

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

    From baseline to 12 weeks

Secondary Outcomes (1)

  • identify patient's satisfaction by Patient Self Assessment

    from baseline to 3 months after treatment

Study Arms (3)

Combined TXA + GSH-assisted microneedling arm

ACTIVE COMPARATOR

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: microneedlingDrug: Oral tranexamic acidOther: Glutathione

GSH-assisted microneedling arm

ACTIVE COMPARATOR

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

Device: microneedlingOther: Glutathione

Oral TXA

ACTIVE COMPARATOR

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

Interventions

microneedlingDEVICE

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.

Combined TXA + GSH-assisted microneedling armGSH-assisted microneedling arm
Oral tranexamic acidDRUG

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

Combined TXA + GSH-assisted microneedling armOral TXA
GlutathioneOTHER

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

Combined TXA + GSH-assisted microneedling armGSH-assisted microneedling arm

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female patients
  • /50 years old
  • facial melasma

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Melanosis

Interventions

Percutaneous Collagen InductionTranexamic AcidGlutathione

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitationCyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Rana Sameer, Postgraduate student

CONTACT

+201064123736Ranasamer3344@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 4, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-02