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A randomized, double-blind, split-face study of the efficacy of using tranexamic acid injection for the treatment of melasma

A randomized, investigator blind, split-face study of the efficacy of using tranexamic acid injection for the treatment of melasma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240731005
Enrollment
30
Registered
2024-07-31
Start date
2024-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male or female patients aged 18-60 years with melasma on both sides of the face. malasma, tranexamic acid, intralesional injections

Interventions

The group receiving an injection of TA at a concentration of 4 mg/ml: 0.1 ml of TA (250 mg/5 ml) is drawn and mixed with 0.9% NSS to make 1 ml. Then, 0.8 ml of this mixture is combined with 0.2 ml of
Tranexamic acid(TA) 4 mg/ml,Tranexamic acid(TA) 40 mg/ml,Normal saline

Sponsors

none
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, aged 18-60 years, diagnosed with facial melasma. 2. Volunteers with mild to severe melasma (mMASI 1-24) that is symmetrical and of equal severity (mMASI difference not exceeding 5) between both sides of the face, assessed using the mMASI score criteria.

Exclusion criteria

Exclusion criteria: 1. Individuals with a history of allergic reactions to tranexamic acid or anesthetics. 2. Those who have used topical vitamin A derivatives or hydroquinone within 3 months prior to the study. 3. Individuals with a history of using other topical agents that affect skin color, such as arbutin, azelaic acid, kojic acid, or cosmetic products with skin-lightening properties within 4 weeks prior to the study. 4. Individuals with contact dermatitis, photosensitivity dermatitis, erythematous inflammation, skin infections, or other abnormal skin pigmentation issues besides melasma on the treatment area of the face. 5. Those who have undergone procedures like chemical peels or laser treatments on the research area of the face within 6 months before the study. 6. Individuals with a history of taking oral contraceptives or hormone therapy within 6 months before the study. 7. Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
mMASI baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 16 weeks, and 24 weeks ranges from 0 (clear) to 24 (most severe melasma)

Secondary

MeasureTime frame
Skin color baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 16 weeks, and 24 weeks by colorimeter (mg/L),melanin index baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 16 weeks, and 24 weeks Antera 3D (melanin index(unit)),Pain score week0 (after injection), 2 weeks, 4 weeks, 6 weeks, 8 weeks, ranged from 0(no pain) to 10 (severe pain) ,Patient's satisfaction score 8 weeks, 16 week, and 24 weeks Patient Satisfaction Scale(0-10)

Countries

Thailand

Contacts

Public ContactChanat Kumtornrut

Faculty of Medicine, Chulalongkorn University

chanat_1@yahoo.com6622564253

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026