Male or female patients aged 18-60 years with melasma on both sides of the face. malasma, tranexamic acid, intralesional injections
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Faculty of Medicine, Chulalongkorn University