1

Acquired diffuse hypermelanosis

Characterized by localized, symmetrical, irregular, light-to-
dark brown maculae
Occurring in sun-exposed areas of the skin
Especially the cheeks, upper lips, the chin, and the forehead

WHAT IS Commonly in females (female to male ratio, 9:1)

Those with darker complexion – Fitzpatrick’s skin types IV-VI

MELASMA?
 2
SIGNIFICANT
PSYCHOLOGICAL IMPACTS
DUE TO DISFIGURING NATURE

Anxiety Low self-esteem

Depression Poor body image

 3
THE EXACT CAUSES OF MELASMA ARE UNKNOWN!!!!

TRIGGERING FACTORS

1 Sun exposure 6 Ovarian tumors

2 Pregnancy 7 Intestinal parasitoses
3 Use of oral contraceptive 8 Thyroid dysfunction

4 Pills 9 Cosmetic
5 Steroids 10 Photosensitizing drugs
 4
TREATMENTS IN MELASMA
Suppression of Removal of already present melanin in
melanogenesis the epidermis and dermis

Peeling (Superficial &

Sunscreen medium depth peels)
Tinted sunscreens (UV and visible light) Trichloroacetic acid, Glycolic acid,Salicylic acid, Jessner's
solution, Tretinoin peels, Phytic acid peels, Amino fruit peels

Inhibiting the melanin production

Lasers
Hydroquinone, Arbutin, Ellagic acid, Rucinol, Azelaic acid, Licorice
Q-switched lasers, Ruby, Alexandrite, Nd-YAG, Ablative lasers,
extract, Kojic acid, Ascorbic acid, Retinoids, Dioic acid, N-Acetyl
CO2, Erbium, Fractional ablative and non-ablabtive lasers,
Glucosamine, Mulberry extract, Silymarin,Resveratol,
Fractional Q-swtiched Ruby lasers and Pulsed dye laser
Oligopeptides, Tranexamic acid,Metformin

Inhibiting the melanin Transfer

Intense pulsed light
Soy, Niacinamide
 5

NO TREATMENT HAS BEEN PROVEN TO BE

CONSISTENTLY SATISFACTORY.
TREATING MELASMA REMAINS A CHALLENGE FOR
DERMATOLOGISTS

RECURRENCE IS COMMON!!!
 6
CURRENT GOLD STANDARD SECOND-LINE
TREATMENT TREATMENT

HYDROQUINONE LASER

Potential Risks Potential Risk

Contact Dermatitis Confetti-like hypopigmentation
Exogenous ochronosis

https://jcadonline.com/the-asian-problem-of-frequent-laser-
https://ijdvl.com/exogenous-ochronosis/
toning-for-melasma/
 7

SO, THERE IS NO MORE

POTENTIAL EFFECTIVE
TREATMENT WITH LESS OR
MILD SIDE-EFFECT FOR
MELASMA???
 8

Yes!!! Of course
It's "Tranexamic
1 Acid"

HOW TRANEXAMIC ACID IS DIFFERENT FROM CURRENT
TREATMENTS FOR MELASMA?
All the pre-existing treatment of melasma aim
at reducing the formation of melanin from
melanocyte (topical agents) and eliminating
pre-existing melanin pigment (peeling, IPL,
laser). However, they inevitably may activate
melanocyte by different irritation,
inflammation or by injuries to keratinocyte
that lead to recurrence or postinflammatory
hyperpigmentation (PIH).
9
Tranexamic acid is now the only modality that
can actually prevent the activation of
melanocyte by sun- light, hormonal influence,
and injured keratinocyte (after UV, peeling,
IPL, laser) through the inhibition of the PA
activation system. It can not only reduce the
formation of melasma, but also reduce the
likelihood of recurrence after other treatment
modalities themselves activate melanocyte.
 10

TRANEXAMIC ACID
Trans-4-Aminomethylcyclohexane-carboxylic acid
Synthetic derivative of the amino acid lysine
A plasmin inhibitor
Reversibly blocking lysine binding sites on plasminogen molecules
Inhibiting the plasminogen activator (PA) from converting plasminogen to
plasmin.
Use to prevent abnormal fibrinolysis to reduce the blood loss.
Widely used clinically for over 30 years for hemorrhagia, angioedema and
primary and secondary hyperfibrinolysis.
No serious side-effect are observed even when the dosages were increased to
4-4.5g/day.

PHARMACODYNAMIC & PHARMACOKINETIC
PROPERTIES OF TA
Orally taken, TA will reach the
peak plasma concentrations
within 3 h and is not affected
by food in the GI tract.
For intravenous administration,
45% of the dose is recovered
in urine in the first 3 h, and 90%
of the drug is eliminated mostly
in 1 day.
11
The drug can cross the
blood–brain barrier and the
placenta, but excretion into
breast milk is minimal.No
mutagenic activity or harmful
fetal effects have been
reported..
 12

HISTORY OF TRANEXAMIC ACID

USED IN MELASMA
In 1979, Nijo Sadako had tried to use TA to treat a patient with chronic
urticaria . Incidentally, he found that the melasma severity of that
patient was significantly reduced after 2–3 weeks. Then, he put on the
first trial of TA on melasma patients and showed that 1.5 g of daily oral
TA together with vitamin B, C, and E supplements for 5 months has an
obvious response in 11/12 patients aged 30–69. Most of the effect was
noticed within 4 weeks of therapy.
In that time period, the mechanism of TA affecting the severity of
melasma remained unknown.
 13
UV light
Plasmin
Sc-UPA

MELANOCYTE
KERATINOCYTE

Plasminogen
activator
aMSH

Pregnancy, oral
contraceptive

Fibroblast
Plasmin
growth factor
Induction of PA

Arachidonic PGE2
acid Leukotrienes
Mast cell VEGF

Angiogenesis
= TA Pathogenesis of melasma and role of tranexmic acid
 14

PROMISING EFFECTS
OF TA ON MELASMA
 15
ORAL TA IN TREATMENTS OF MELASMA
Patient Dose &
Study Accessment tool Result Comment
number Duration

Oral TA provides rapid and

500 mg daily for Significant decrease in the mean MASI
Karn et al. (2012) 260 MASI sustained imprvement in the
3 months from baseline to 8 and 12
treatment of melasma

Clinical and Patients rating for excellent, good, fair Oral TA is effective and
500 mg dialy for
Wu et al. (2012) 74 photographic and poor outcome accounted 10.8%, 54%, safe for treatment of
6 months
assessment 31.% and 4.1% respectively melasma

The MI and EI scores decreased

significantly. Significant reduction of TA decreased epidermal
1500 mg daily for
Na et al. (2012) 25 MI and EI scores epidermal pigmentation, vessel numbers pigmentation associated
2 months
and mast cell count in histological with melasma.
analysis.

Clinical and Patients rating for excellent, good, fair Oral TA is safe and
Aamir and 500 mg daily for
65 photographic and poor outcome accounted 23%, 63%, effective for treatment of
Naseem 6 months
assessment 12% and 1.5% respectively. melasma
 16
ORAL TA IN TREATMENTS OF MELASMA
Patient Accessment
Study Dose & Duration Result Comment
number tool

5 point scoring Oral TA seems to be a

Improved patient accounted for 85% in
Li et al system in skin 1500 mg daily for 4 potentially new and
35 4 weeks, 97% in 8 and 12 weeks and
(2014) tone color months promising therapeutic
100% in 16 weeks.
scale option.

500 mg daily and topical

Fast reduction in pigmentation in
cream containing Addition of oral TA to triple
Padhi and combination group as compared to
fluocinolone acetonide combination cream rsults
Pradhan 40 MASI topical group was shown and the results
0.01%, tretinoin 0.05% in a faster and sustained
(2015) were statistically significant at 4 weeks
and hydroquionone 2% improvement
and 8 weeks.
once daily for 2 months

500 mg daily in addition The mean MASI scores after TA Low-dose oral TA can
Tan et al. to pre-existing treatment were significantly lower than serve a safe and useful
25 MASI
(2016) combination topical those prior to treatment. The mean adjunct in the treatment of
therapy improvement in scores was 69% refractory melasma.

Physician Oral TA may be an

Lee et al. TA 250 mg twice daily for 89.7% patient showed improvement, 10%
561 Global effective adjunct for
(2016) 4 months remained unchange and 0.4% worsened.
Assessement refractory melasma.
 TOPICAL TA IN TREATMENTS OF MELASMA 17
Patient Accessment
Study Dose & Duration Result Comment
number tool

Group A: 12.5% improved, 50%

3% TA cream twice a day
Photographic, worsening and no change in 37.5%.
or once weekly of Significant improvement with
Steiner et MASI, Group B: 66.7% improved, 11.1%
18 intradermal injections no statistical difference
al.(2009) colormetry worsening and non changed in 22.2%.
with TA 0.05 ml (4mg/ml) between groups.
evolution Significant improvement with no
for 12 weeks
difference between treatments.

3% TA topical solution or
Ebrahimi topical solution of 3% A significant decreasing in MASI score Topical TA as effective and
et al. 50 MASI hydroquinone ,0.01% of both groups with no significant safe medication for the
(2014) dexamethasone twice difference between them. treatment of melasma.
daily for 12 weeks

5% TA topical liposomal The mean MASI scores significantly

Banihashe Topical liposomal TA can be
or reduced in both side after 12 week. A
mi et al. 30 MASI used as an effective and safe
4% hydroquinone cream greater decrease was observed with 5%
(2015) therapeutic agent
twice daily for 12 weeks liposomal TA.

The mMASI scores significantly

Kim et al. 2% TA twice daily for 12 Topical TA is effective as a
23 mMASI improved in 22 out of 23 patients after
(2016) weeks treatment for melasma
12 weeks application
 18
INTRADERMAL TA IN TREATMENTS OF MELASMA
Patient Accessme
Study Dose & Duration Result Comment
number nt tool

MASI
Intradermal TA as effective
Lee et al. patient Weekly intradermal injections 8 patients rated good, 65 rated fair and
85 for the treatment of
(2006) Satisfaction of 0.05% (4mg/ml) TA 12 rated poor results.
melasma.
score

Treatment group: intradermal

TA and glutathione montly + No side effect reported.
Treatment group had statistically
Feng et al. topical hydroquinone every Intradermal TA adds to the
180 MASI significant better results than control
2018 night effect of topical
group
hydroquinone.
Control group: Topical only

TA (20mg/ml) intradermally At one month TA was better than HQ Intradermal TA may be

Saki et.al
37 MI and EI monthly vs topical At week 20, no difference between two more beneficial than 2%
(2018)
hydroquinone 2% groups hydroquinone

Budamask 35.72% improvement in Intradermal The improvement was

Intradermal TA 4mg/ml Vs
untla et al 60 mMASI group and 44.41% improvement in maintained at 3 months of
microneedling monthly
(2013) microneedling group follow-up
 19
ADVERSE EFFECTS TXA is a well-tolerated drug and it is mostly
considered safe at the usual dosage. Nausea
and diarrhea are the most common side effects.

Other systemic side effects observed with low-dose

administration include oligomenorrhea, gastric
upset, and palpitations.

Venous thromboembolism, myocardial

infarction, cerebrovascular accidents, and
pulmonary embolism have been reported when
given in hemostatic doses (up to 1000 mg daily).

Mild discomfort, burning sensation, and erythema

were observed when it was used intradermally,
which subsided without the need for other
interventions
 20
INTERESTING STUDIES OF TRANEXAMIC ACID
IN TREATMENT OF MELASMA
1

Comparative study of efficacy of intradermal tranexamic acid versus topical

tranexamic acid versus triple combination in melasma
2

A Randomized Comparative Study of Intralesional Tranexemic Acid and Kligman’s

Regimen in Indian Patients with Melasma
3

A comparative study of topical 5% tranexamic acid and triple combination therapy for
the treatment of melasma in Indian population
4

TThe optimal dose of oral tranexamic acid in melasma: A network meta-analysis

21

MATERIALS & METHOD
Total 205 patients with mild-to-severe
melamsa patient
Group A (65 patients) - Intradermal TA
Group B (76 patients) - Topical TA
Group C (64 patients) - Topical triple
combination
RESULTS
MASI score at baseline and at 6 months for
Group A,B and C was 15.4 and 2.2, 15.4 and 6.4,
and 15.3 and 5.4 respectively.
MASI score decreased in all three groups but it
was statisitcially significant in Group A followed
by Triple combination therapy.
22
DRUGS & DOSAGE
Intradermal TA - 0.05ml (4mg/ml) injection in
each cm2 melasma every 15 days
3% TA cream once a day
Triple combination ( hydroquinone 2%,
tretinoin 0.025%, flucocinolone acetonide
0.01% once a day
ADVERSE EFFECTS
Group A and B showed lesser side effect than
Group C.
Mild discomfort, burning sensation & erythema
were observed in intradermal injection.
Acne eruption, erythema, hypopigmentation
and hypertrichosis were observed in Triple
combination therapy.
 23
INTRADERMAL TA GROUP

ORDER NOW

BEFORE

AFTER
 24

TOPICAL TA GROUP

ORDER NOW

BEFORE
AFTER
 25

TRIPLE COMBINATION THERAPY GROUP

ORDER NOW

BEFORE
AFTER
26

MATERIALS & METHOD
Total 60 patients with mild-to-severe
melamsa patient
Group A (29 patients) - Intralesional TA
Group B (30 patients) - Kligman's formula
RESULTS
Decrease in mean MASI score is statistically
significant in both groups on week 4, 8 and 12.
Between intergroup, there is significant
difference only at week 12, with group B
showing better response to therapy.
27
DRUGS & DOSAGE
Intradermal TA - 0.05ml (4mg/ml) injection in
each cm2 melasma every 2 weeks
Kligman's formula ( hydroquinone 4%,
tretinoin 0.05%, flucocinolone acetonide
0.01% daily
Total - 10 weeks
ADVERSE EFFECTS
Group A showed no significant side-effects
Group B showed erythema, burning and
hypopigmentation in 18 patients.
28
 29
MATERIALS & METHOD DRUGS & DOSAGE

Total 23 out of 25 patients completed the
research
Group A (left side of face) - Topical TA
Group B (right side of face) - Topical triple
combination therapy
5% Tranexamic acid applied twice a day
Triple combination ( hydroquinone 2%,
tretinoin 0.025%, flucocinolone acetonide
0.01%) once a day
Total - 3 months

RESULTS ADVERSE EFFECTS

The mean MASI scores decreased statistically Group A showed lesser side effect than
significant in both groups but there is no Group B.
significant difference between the two groups. Erythema, irritation and talengiectasia were
observed
30
 31
INDIVIDUAL STUDIES INCLUDED IN META-ANALYSIS
Patient Accessment
Study Dose & Duration Treatment duration (weeks) Recruiting area
number tool

Karn et.at Oral TA 500mg/day Vs

260 MASI 12 Nepal
(2012) placebo

Jung et al. Oral TA 750mg/day Vs

44 mMASI 8 Korea
(2013) placebo

Vihideh et Oral TA 750mg/day Vs

88 MASI 12 Iran
al. (2017) placebo

Mariana et Oral TA 500mg/day Vs

37 MASI 12 Brazil
al. (2018) placebo

Khushboo
Oral TA 500mg/day Vs
et al. 120 mMASI 12 India
placebo
(2020)

Nahla et al. Oral TA 500mg/day Vs

50 mMASI 12 Indonesia
(2020) placebo
 32
RESULT
A dose of 750 mg per day of oral tranexamic acid for
12 consecutive weeks was found to be the optimal
dose and duration to treat meslama.
The effect of oral tranexamic acid 250 mg twice daily
and three times daily over 12 weeks are similar.
Tranexamic acid 500 mg per day for 12 weeks had a
better outcome than 750 mg per day for 8 weeks.
Show that the duration of therapy may have been
more important than the total daily dosage.
 33

ABSOLUTE RELATIVE CONTRAINDICATION

CONTRAINDICATIONS
Active thromboembolic disease: DVT, PE, Concomitant use with the oral
Cerebral thrombosis contraceptive pill
Personal or family history of
Acute promyelocytic leukaemia
thromboemobolism including DVT, PE,
taking all-trans retinoi acid
cerebral thrombosis, cerebral retianl vein or
artery occlusion Breast feeding
Intrinsic risk of thrombosis or Renal/hepatic impairment: may
thromboembolism, e.g thrombogenic valvular require dose adjustment
disease, thrombogenic cardiac rhythm disease
or hypercoagulopathy
Hypersensitivity to TA
Severe renal insufficiency
Acquired disturbances of colour vision
 34

Optimal dose - 750 mg per day (250 mg three times

per day
The duration of therapy is more important than the

TAKE HOME
dosage
Even though, the lightening effect is visible earlier, the

MESSAGE
minimum recommended duration is 3 months
For the intralesional injection, 4 mg/ml to 50 mg/ml
can be used as a safe and effective
For topical TA, 2% to 5% concentration are as
effective as the HQ.
 35

Tranexamic acid can be used for melasma with the

unresponsive to standard treatments

TAKE HOME Tranexamic acid is the only agent that can be used
in melasma by inhibiting UV light-induced
MESSAGE melanocyte activation, hormone-induced
melanocyte proliferation, VEGF-induced
neovascularization and mast cell-induced basement
membrane damage.
 36

Patients should be counselled about the rare risk of

thromboembolic events, and underlying risk factors

TAKE HOME should be ascertained before initiation of treatment.

Tranexamic acid is a promising, safe and effective
MESSAGE drug for the treatment of melasma.
 37
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 40
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 42
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