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

ConditionMelasma
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• female patients

18/50 years old

facial melasma

Disqualifiers

pregnancy

lactation.

History of any bleeding,

clotting disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

42 Participants
are divided into 3 treatment groups
Group A: Combined TXA + GSH-assisted microneedling armActive comparator 3 interventions
Group B: GSH-assisted microneedling armActive comparator 2 interventions
Group C: Oral TXAActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: