Seoul
Chief MD, Gangnam
Duk-ha Kim
The trust our patients have placed in this clinic was built on conviction and principle. We intend to hold to both, unchanged, through the next hundred years.
Tranexamic acid injection treatment guide
Melasma Injection
Melasma injection at Abijou means tranexamic acid delivered by injection — an antifibrinolytic drug whose Korean and US labels are written for bleeding control, not for pigmentation. Its use for melasma comes from a separate body of clinical trial evidence with mixed results across oral, injection and topical routes, and a personal history of clotting risk factors has to be checked before it is considered.
- What this is
- Tranexamic acid delivered by injection — a systemic drug, not a laser or energy device
- Labelled indication
- Bleeding tendency from hyperfibrinolysis (KR); short-term perioperative bleeding control in haemophilia (US) — melasma is not listed
- Labelled route
- Intravenous or intramuscular injection; intradermal facial injection is a trial protocol, not a labelled route
- Route comparison (2017 meta-analysis)
- Oral SMD -2.46, injection -1.42, topical -1.36 (not significant)
Is this page about a drug or a device?
This page is about a drug, not a device — tranexamic acid delivered by injection, not a laser or energy-based machine. That distinction matters for how the evidence should be read: an injectable drug carries a national drug label with its own approved indications, contraindications and route of administration, and using it for melasma has been tested in clinical trials that sit outside what the label itself describes. The rest of this page works through what the Korean and US drug labels actually say tranexamic acid injection is for, what published trials measured when it was used off-label for melasma, and what a history check needs to cover before any of that becomes relevant.
What does the Korean drug label say tranexamic acid injection is approved for?
The Korean Ministry of Food and Drug Safety drug product record for tranexamic acid injection lists its efficacy and effect as bleeding tendencies and abnormal bleeding associated with systemic and local hyperfibrinolysis, and it defines the route of administration as intravenous or intramuscular injection. The contraindication list includes patients with thromboembolism or a history of thromboembolism, and the precaution list includes patients with cerebral thrombosis, myocardial infarction, thrombophlebitis or other existing thrombus. These entries describe an antifibrinolytic drug used for bleeding control, not a pigmentation treatment, and none of them describe intradermal injection into facial skin.
What does the US injectable label say tranexamic acid is approved for?
The US prescribing information on DailyMed for Cyklokapron (tranexamic acid) injection lists the approved use as short-term (2 to 8 days) reduction or prevention of haemorrhage during tooth extraction in patients with haemophilia. The warnings section lists reports of venous and arterial thrombosis, and the contraindication is active intravascular clotting. Like the Korean record, this label describes a short perioperative course in a bleeding disorder, not a course of aesthetic injections for facial pigmentation.
Sources: DailyMed — CYKLOKAPRON (tranexamic acid) injection prescribing information, indications and warnings
Do either label list melasma or intradermal injection?
Neither the Korean drug record nor the US prescribing information lists melasma, pigmentation, or any skin-lightening indication, and neither one describes intradermal injection as a route of administration — the Korean label specifies intravenous or intramuscular injection, and the US label describes a short perioperative course tied to tooth extraction in haemophilia. What is written on these two labels and what published melasma trials actually did — injecting the drug into the facial dermis on a repeating schedule — are two different things, and a consultation should be able to explain that gap rather than treat the label as if it already covered this use.
Sources: MFDS drug product record — tranexamic acid injection, approved indications and route of administrationDailyMed — CYKLOKAPRON (tranexamic acid) injection prescribing information, indications and warnings
Who is excluded from this injection under the drug labels?
Both labels point to the same category of patient who should not receive this drug. The contraindication list on the Korean label includes patients with thromboembolism or a history of it, and the precaution list adds patients with cerebral thrombosis, myocardial infarction, thrombophlebitis or another existing thrombus. The contraindication on the US label is active intravascular clotting, alongside warnings of reported venous and arterial thrombosis. Because the drug acts on clotting throughout the body rather than on skin tissue directly, this exclusion list is what a consultation needs to rule out before anything about melasma is discussed.
Sources: MFDS drug product record — tranexamic acid injection, approved indications and route of administrationDailyMed — CYKLOKAPRON (tranexamic acid) injection prescribing information, indications and warnings
What did the 2017 meta-analysis find for each route?
A 2017 meta-analysis in Acta Dermato-Venereologica pooled 11 studies covering 667 patients treated with tranexamic acid for melasma, broken down by route. Oral dosing showed a standardised mean difference of -2.46 (95% CI 1.13 to 3.80, p<0.001, I²=71%); injection showed -1.42 (95% CI 0.98 to 1.87, p<0.001, I²=72%); topical application showed -1.36, which did not reach statistical significance (p=0.08, I²=87%). Across monotherapy studies overall, the pooled MASI reduction was 1.60 (95% CI 1.20 to 2.00).
Sources: Acta Derm Venereol 2017 — meta-analysis of tranexamic acid for melasma (11 studies, 667 patients)
Why does a high I² change how these numbers should be read?
Every one of those numbers carries an I² above 70%, and the topical figure reaches 87% — a level that means the individual studies being pooled did not agree with each other, not that the summary number itself is wrong. Heterogeneity this high usually reflects differences in dose, treatment duration, patient population and how MASI was scored across the 11 included studies. A summary effect built from very inconsistent studies is a starting point for judging what has been tried, not a number that predicts one result for one person.
Sources: Acta Derm Venereol 2017 — meta-analysis of tranexamic acid for melasma (11 studies, 667 patients)
What did the 2018 meta-analysis add?
A separate 2018 meta-analysis in BioMed Research International pooled a larger set — 21 studies covering 1,563 patients — and reported the oral route at a mean difference of -1.866, topical at -1.850, and injection at -1.673. The review authors stated directly that the studies included in their analysis were of low quality, a limitation that applies to the numbers regardless of which route they are attached to.
Do the two meta-analyses agree on which route ranks first?
The two meta-analyses do not rank the three routes the same way. The 2017 review put oral ahead of injection, with topical failing to reach significance; the 2018 review put oral ahead of topical, with injection trailing slightly behind and all three routes closer together in magnitude. Both reviews report substantial heterogeneity or low study quality behind their numbers. Read together, they do not establish that any one route is the strongest option — they show that oral, injection and topical tranexamic acid have all been studied for melasma with mixed and inconsistent pooled results.
Sources: Acta Derm Venereol 2017 — meta-analysis of tranexamic acid for melasma (11 studies, 667 patients)BioMed Research International 2018 — systematic review and meta-analysis of tranexamic acid for melasma (21 studies, 1,563 patients)
What did the split-face trial against topical hydroquinone actually measure?
The most direct route comparison for injection specifically is a 2023 double-blind, split-face randomised trial in the Journal of Clinical and Aesthetic Dermatology, with 48 participants. One side of the face received intradermal tranexamic acid at 100 mg/mL every two weeks; the other side received topical 4% hydroquinone. Over three months of treatment plus three months of follow-up, the mean MASI score on the injection side moved from 6.1 to 3.5. Every participant reported mild burning at the injection site, and no serious adverse events were recorded. This is a single-centre trial with a small sample, so it supports a within-trial comparison rather than a population-level conclusion.
Does melasma return after the injection course ends?
Melasma treated with tranexamic acid has been reported to return after treatment stops, though the published numbers are not consistent enough to state as one figure. A study cited within the 2017 meta-analysis recorded a 72% relapse rate within two months of discontinuation, and the 2023 split-face trial also describes a high rate of relapse after treatment ends. Both of these come from small samples and differ from each other, so this page does not present a single relapse percentage as the expected outcome — only that relapse after stopping has been reported more than once.
Sources: Acta Derm Venereol 2017 — meta-analysis of tranexamic acid for melasma (11 studies, 667 patients)J Clin Aesthet Dermatol 2023 — double-blind split-face randomised trial of intradermal tranexamic acid versus topical hydroquinone (n=48)
Is the injection safer than taking tranexamic acid by mouth?
There is no comparative safety trial in the sources behind this page that tests the injection route against the oral route head-to-head. The thrombosis data available (see below) comes from a cohort study of oral tranexamic acid, and the safety information reported for injection comes from a small split-face trial that compared it to a topical cream, not to oral tablets. Without a study that places the two routes side by side for safety, a claim that one is safer than the other is not something the evidence here supports.
Sources: JAAD International 2025 — propensity-matched cohort on venous thromboembolism risk with oral tranexamic acid (682 matched pairs)J Clin Aesthet Dermatol 2023 — double-blind split-face randomised trial of intradermal tranexamic acid versus topical hydroquinone (n=48)
What thrombosis risk has actually been measured for oral tranexamic acid?
The clearest thrombosis data available comes from a 2025 propensity-matched cohort study in JAAD International, covering 682 matched pairs treated between 2005 and 2024 for oral tranexamic acid use. At 120 days, venous thromboembolism occurred in 1.6% of the oral tranexamic acid group and 1.6% of the matched comparison group (hazard ratio 1.01, 95% CI 0.42 to 2.41), and arterial thrombosis occurred in neither group. This is a retrospective study that relies on diagnosis codes to identify cases, and it examined the oral route rather than injection — its numbers describe oral use, not what happens with the injected drug.
How long does the effect last?
The only route-specific duration data on this page comes from the 2023 split-face trial, which ran a treatment course of three months followed by three months of follow-up, with injections given every two weeks and MASI reassessed across that window — that is the actual observation period behind the numbers reported elsewhere on this page, not an indefinite result. The relapse reports tied to this drug describe the same pattern from a different angle: a study cited within the 2017 meta-analysis recorded a 72% relapse rate within two months of discontinuation, and relapse has been reported to climb further, toward 60% by around 48 weeks, in the same body of literature. Those figures come from small samples that differ from each other, so this page does not present one relapse curve as a confirmed trajectory — only that relapse after stopping has been reported repeatedly, and that it appears to continue past the two-month mark rather than stopping there. Read together, the treatment period actually studied is measured in months, is followed by a documented tendency for melasma to return, and no source here follows a patient beyond that follow-up window to say what happens next. What a consultation can usefully cover is how the treating doctor plans reassessment during and after the course, and whether repeat treatment or a maintenance plan is being proposed and on what basis.
Sources: Acta Derm Venereol 2017 — meta-analysis of tranexamic acid for melasma (11 studies, 667 patients)J Clin Aesthet Dermatol 2023 — double-blind split-face randomised trial of intradermal tranexamic acid versus topical hydroquinone (n=48)
What side effects were reported in the route-comparison studies?
The 2017 meta-analysis also recorded non-thrombotic side effects in the oral-route studies it pooled: hypomenorrhoea in 14.7% of patients, abdominal cramping in 6.9%, and headache in 11%. The side effect recorded on the injection side of the 2023 split-face trial was mild burning at the injection site in every participant, with no serious adverse events. These figures come from different routes and different study designs, so they describe what was reported in each specific study rather than one combined side-effect profile for the drug.
Sources: Acta Derm Venereol 2017 — meta-analysis of tranexamic acid for melasma (11 studies, 667 patients)J Clin Aesthet Dermatol 2023 — double-blind split-face randomised trial of intradermal tranexamic acid versus topical hydroquinone (n=48)
What history should be checked before this injection is booked?
Tranexamic acid acts on clotting throughout the body rather than on skin tissue directly, so the history taken before this injection matters more than which device or technique is used. A consultation needs to establish, before anything about melasma is discussed, a personal or family history of blood clots, current use of oral contraceptives, pregnancy or breastfeeding, smoking status, and any diagnosed clotting-related condition. These are the same categories of patient placed in the contraindication and precaution lists on the drug labels, and they apply whether the drug is taken by mouth or injected.
Sources: MFDS drug product record — tranexamic acid injection, approved indications and route of administrationDailyMed — CYKLOKAPRON (tranexamic acid) injection prescribing information, indications and warnings
What does a treatment course and follow-up look like in the cited trial?
The one route-specific trial on this page, the 2023 split-face study, ran a treatment course of three months followed by three months of follow-up, with injections given every two weeks and MASI reassessed over that period. That schedule belongs to a single 48-person trial, not a universal protocol, and the relapse reports described above mean that what happens after the follow-up window closes is not settled by this study alone. A course built around this evidence should include a plan for reassessment during and after treatment, not just a fixed number of sessions.
Which route, which reported effect size, which study design?
Read this as a map of what each source measured for the same three routes, not as a ranking. The rows list the effect size each meta-analysis reported for oral, injection and topical tranexamic acid, and the design behind the number.
| Route | 2017 meta-analysis (11 studies, 667 patients) | 2018 meta-analysis (21 studies, 1,563 patients) | What the number is based on |
|---|---|---|---|
| Oral | SMD -2.46 (95% CI 1.13-3.80, p<0.001, I²=71%) | Mean difference -1.866 | Neither drug label lists melasma as an approved use for this route; the 2017 pooled studies show high heterogeneity and the 2018 review authors rated their own included studies as low quality |
| Injection | SMD -1.42 (95% CI 0.98-1.87, p<0.001, I²=72%) | Mean difference -1.673 | The labelled route is intravenous or intramuscular injection for bleeding control, not intradermal injection for melasma; a 2023 split-face trial used intradermal 100 mg/mL every two weeks and reported a MASI change from 6.1 to 3.5 over three months |
| Topical | SMD -1.36 (p=0.08, not significant, I²=87%) | Mean difference -1.850 | Comparator arm in the 2023 split-face trial (4% hydroquinone) and the topical-arm studies pooled in both meta-analyses |
These figures come from two separate meta-analyses that pooled different and only partly overlapping sets of studies, plus one split-face randomised trial for the injection-versus-topical comparison specifically. They are not one single trial comparing all three routes head-to-head, and neither drug label behind the injection route lists melasma as an approved indication.
Sources: Acta Derm Venereol 2017 — meta-analysis of tranexamic acid for melasma (11 studies, 667 patients)BioMed Research International 2018 — systematic review and meta-analysis of tranexamic acid for melasma (21 studies, 1,563 patients)J Clin Aesthet Dermatol 2023 — double-blind split-face randomised trial of intradermal tranexamic acid versus topical hydroquinone (n=48)MFDS drug product record — tranexamic acid injection, approved indications and route of administrationDailyMed — CYKLOKAPRON (tranexamic acid) injection prescribing information, indications and warnings
Medical care at Abijou
Care is provided by the medical team at the branch you select. These clinicians lead the three branches linked from this guide; confirm the doctor assigned to your visit with that branch.
Chief MD, Myeongdong
Cheol-su Yoon
I want to be thinking about how the patient feels right up to the last moment of the procedure.
Chief MD, Hongdae
Jae-wook Kim
I will give my best with the attentiveness to catch even the smallest change.
Listed branch medical team — not a medical-review byline for this article.
Frequently asked questions
Is a melasma injection approved for treating melasma?
No. Neither the Korean drug record nor the US prescribing information for tranexamic acid injection lists melasma or any pigmentation condition as an approved indication. The Korean record approves its use for bleeding tendency and abnormal bleeding linked to hyperfibrinolysis, and the US label approves short-term bleeding control around tooth extraction in patients with haemophilia. Its use for melasma is studied in clinical trials rather than written on either drug label.
Is intradermal injection into facial skin an approved route on the label?
No. The route defined on the Korean label is intravenous or intramuscular injection, and the US label describes a short perioperative course tied to tooth extraction — neither one lists intradermal injection into facial skin. The intradermal schedule used for melasma, such as the 100 mg/mL dose given every two weeks in a 2023 split-face trial, comes from a clinical trial protocol, not from either approved label.
Who should not receive this injection?
Anyone with thromboembolism or a history of it, according to the contraindication list on the Korean label, and anyone with active intravascular clotting, according to the contraindication on the US label. Both labels also flag caution for a history of cerebral thrombosis, myocardial infarction or thrombophlebitis, and the US label warnings list reported venous and arterial thrombosis. These are the categories a consultation needs to rule out before anything about melasma is discussed.
How much does the injection actually reduce melasma, according to the studies?
In the 2017 meta-analysis, the pooled injection studies showed a standardised mean difference of -1.42 (95% CI 0.98 to 1.87, p<0.001), and the 2018 meta-analysis reported a mean difference of -1.673 for injection. In the one split-face randomised trial that used intradermal injection, the mean MASI score on the treated side moved from 6.1 to 3.5 over three months. Both meta-analyses report high heterogeneity or low study quality behind their pooled numbers, so these figures describe study populations rather than a fixed result for any one person.
Why do the 2017 and 2018 meta-analyses report different numbers for the same drug?
Because they pooled a different and only partly overlapping set of studies — 11 studies and 667 patients in 2017 against 21 studies and 1,563 patients in 2018 — and the two do not rank the three routes the same way. The 2017 review put oral ahead of injection, with topical not reaching significance; the 2018 review put oral ahead of topical, with injection trailing close behind. The 2018 review authors also rated the studies in their own pooled analysis as low quality. Different study sets and different quality levels produce different pooled numbers; that does not mean one review is right and the other wrong.
Does the injection work better than a topical cream for melasma?
One trial compared them directly: a 2023 double-blind split-face study gave 48 participants intradermal tranexamic acid on one side of the face and topical 4% hydroquinone on the other, and the mean MASI score on the injection side moved from 6.1 to 3.5 over three months of treatment. That is a single trial with a small sample at one centre, so it describes what happened within that trial rather than settling the comparison for every topical product or every patient.
Does melasma come back after the injections stop?
Relapse has been reported, but not as one settled number. A study cited within the 2017 meta-analysis recorded 72% relapse within two months of stopping treatment, and the 2023 split-face trial also describes a high rate of relapse after treatment ends. Both come from small samples and the figures differ from each other, so this page does not quote a single relapse rate as the expected outcome.
Is the injection safer than taking tranexamic acid tablets?
That has not been tested directly — none of the sources behind this page place the injection and oral routes side by side in the same safety study. The thrombosis data available comes from a cohort study of oral tranexamic acid, and the safety data for injection comes from a small trial that compared it to a topical cream, not to tablets. Without a head-to-head study, this page does not state that one route is safer than the other.
What is the actual risk of blood clots with tranexamic acid?
The clearest data available is for the oral route: a 2025 propensity-matched cohort study of 682 matched pairs found venous thromboembolism at 120 days in 1.6% of the oral tranexamic acid group against 1.6% of the matched comparison group (hazard ratio 1.01, 95% CI 0.42 to 2.41), with arterial thrombosis in neither group. That study is retrospective and relies on diagnosis codes, and it examined the oral route rather than injection, so it describes oral use rather than what happens after an injected course.
What side effects have been reported?
In the oral-route studies pooled by the 2017 meta-analysis, hypomenorrhoea was reported in 14.7% of patients, abdominal cramping in 6.9%, and headache in 11%. On the injection side of the 2023 split-face trial, every participant reported mild burning at the injection site, with no serious adverse events recorded. These come from different routes and different studies rather than one combined side-effect profile for the drug.
What should I tell the clinic before this injection?
A history of blood clots, current use of oral contraceptives, pregnancy or breastfeeding, smoking, and any diagnosed clotting-related condition. Tranexamic acid acts on clotting throughout the body rather than on skin tissue directly, so this history matters more than which injection technique is used. These are the same categories placed in the contraindication and precaution lists on the drug labels.
How many sessions does the treatment involve?
In the one route-specific trial cited on this page, treatment ran for three months with injections given every two weeks, followed by three months of follow-up. That schedule belongs to a single 48-person study rather than a fixed protocol, so the number and spacing of sessions in an individual plan is set by the treating clinician.
Can this injection be combined with topical treatment?
The trial evidence here was designed as a comparison rather than a combination: the 2023 split-face trial tested intradermal injection on one side of the face against topical 4% hydroquinone on the other side of the same face. Whether combining an injection course with a topical product changes the result is not something the sources behind this page measured.
What should prompt me to contact the clinic during or after a course of injections?
Because tranexamic acid works on the clotting system, leg swelling or pain, chest pain, shortness of breath, or a sudden change in vision or speech all call for prompt attention. This follows directly from the thrombosis warnings on both drug labels rather than from the melasma studies cited here. For the injection site itself, the 2023 trial recorded mild burning as an expected finding in every participant, not a reason for concern on its own — persistent pain, swelling or a reaction that does not settle is what to raise with the clinic.
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