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

Assiut University

Status and phase

Not yet enrolling

Phase 3

Phase 2

Conditions

Melasma

Treatments

Other: Glutathione

Device: microneedling

Drug: Oral tranexamic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT07448415

Oral TXA & GSH in melasma

Details and patient eligibility

About

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

Full 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.

Enrollment

42 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 3 patient groups

Combined TXA + GSH-assisted microneedling arm

Active Comparator group

Description:

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.

Treatment:

Drug: Oral tranexamic acid

Device: microneedling

Other: Glutathione

GSH-assisted microneedling arm

Active Comparator group

Description:

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

Treatment:

Device: microneedling

Other: Glutathione

Oral TXA