Healthy volunteers aged 20 to 60 years with Fitzpatrick skin types III to IV, presenting with bilateral malar melasma. melasma, botulinum toxin, tranexamic acid, MASI score
Conditions
Interventions
Letibotulinum toxin A 100 units was reconstituted with 10 mL of 0.9% sodium chloride solution. (1:10 dilution) It was then injected intradermally into the melasma lesions using a 31-gauge insulin nee
Experimental Drug,Active Comparator Drug
Botulinum toxin,Tranexamic acid
Sponsors
Phramongkutklao Hospital Foundation
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged 20 to 60 years 2 . Fitzpatrick skin types III to IV 3. presenting with bilateral malar melasma.
Exclusion criteria
Exclusion criteria: 1. Thyroid disorders 2. Current use of isotretinoin, oral contraceptive pills, anticoagulants, or photosensitizing drugs 3. Pregnancy (confirmed by a pregnancy test) or breastfeeding 4. History of hypertrophic scar or keloid formation 5. History of herpes simplex infection involving the lips or face 6. Active acne or poorly controlled inflammatory skin disease 7. History of botulinum toxin injection or facial procedures within the past 6 months 8. History of allergy to tranexamic acid 9. History of allergy to topical anesthetics containing lidocaine or prilocaine 10. Use of topical treatments for melasma within the past 3 months 11. History of seizures 12. Neurological disorders or facial muscle weakness 13. History of thromboembolic disease or coagulation disorders 14. Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hyperpigmentation 0,1,2,1,3,6 month MASI score, Visual Analog Scale, Mexameter, VISIA | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain score, Side effect 0,1,2,1,3,6 month Visual Analog Scale | — |
Countries
Thailand
Contacts
Public ContactRavion Assavanatenapa
Phramongkutklao Hospital and Phramongkutklao College of Medicine
Outcome results
None listed