Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: microneedling, Oral tranexamic acid, Glutathione.
- Who it may be relevant to
- Registry conditions: Melasma. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- 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
Primary outcome measures
- compare reduction of Melasma Area and Severity Index (MASI) score in any treatment modalities [Time frame: From baseline to 12 weeks]
Secondary outcome measures (1)
- identify patient's satisfaction by Patient Self Assessment [Time frame: from baseline to 3 months after treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07448415 · Oral TXA & GSH in melasma