MelasmaPhase 2/3NCT07448415
Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma
A Phase 2/3 study testing microneedling, Oral tranexamic acid and Glutathione in people with Melasma, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Melasma
- What is being tested?
- microneedling, Oral tranexamic acid and Glutathione
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Apr 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • female patients
- 18/50 years old
- facial melasma
Who cannot join
- pregnancy
- lactation.
- History of any bleeding,
- clotting disorder
- using anticoagulants
- Chronic systemic diseases
Show all 14Show fewer
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
Read the 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
- Being tested
- microneedling, Oral tranexamic acid, Glutathione
- Keywords
- Tranexamic acid, glutathione
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Oral tranexamic acidDrug
The patient will take oral tranexamic acid 250mg twice daily for 3 months
GlutathioneOther
investigators will use topical GSH solution in assist with microneedling to treat melasma
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: microneedling; Drug: Oral tranexamic acid; Other: 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. Receives: Device: microneedling; Other: 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. Receives: Drug: Oral tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare reduction of Melasma Area and Severity Index (MASI) score in any treatment modalities
Measured: From baseline to 12 weeks
Secondary outcomes (1)
identify patient's satisfaction by Patient Self Assessment
Measured: from baseline to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Sameer Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448415
- Sponsor's protocol ID
- Oral TXA & GSH in melasma
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07448415
- Acronym / sponsor ID
- Oral TXA & GSH in melasma
- Conditions
- Melasma
- Keywords
- Tranexamic acid, glutathione
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined TXA + GSH-assisted microneedling arm | Active comparator | Device: microneedling, Drug: Oral tranexamic acid, Other: Glutathionewill 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. |
| GSH-assisted microneedling arm | Active comparator | Device: microneedling, Other: Glutathionewill include 14 patients, they will be treated by microneedling assisted with glutathione every 4 weeks for a maximum of 3 months. |
| Oral TXA | Active comparator | Drug: Oral tranexamic acidwill include 14 patients, they will be treated by * oral TXA alone 250mg twice daily for a maximum of 3 months. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • female patients
Key exclusion criteria (14 listed)
- pregnancy
- lactation.
- History of any bleeding,
- clotting disorder
- using anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microneedlingwith 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. | Device | Combined TXA + GSH-assisted microneedling arm, GSH-assisted microneedling arm |
| Oral tranexamic acidThe patient will take oral tranexamic acid 250mg twice daily for 3 months | Drug | Combined TXA + GSH-assisted microneedling arm, Oral TXA |
| Glutathioneinvestigators will use topical GSH solution in assist with microneedling to treat melasma | Other | Combined TXA + GSH-assisted microneedling arm, GSH-assisted microneedling arm |
Primary outcome
compare reduction of Melasma Area and Severity Index (MASI) score in any treatment modalities
Time frame: From baseline to 12 weeks
1 secondary outcome
identify patient's satisfaction by Patient Self Assessment
Time frame: from baseline to 3 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing microneedling, Oral tranexamic acid and Glutathione in people with Melasma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rana Sameer, Postgraduate student (+201064123736, Ranasamer3344@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare reduction of Melasma Area and Severity Index (MASI) score in any treatment modalities (time frame: From baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.