Melasma in Thai women transdermal tranexamic acid delivery for treatment of melasma
Conditions
Interventions
fractional skin resurfacing system based on thermo-
mechanical ablation(Tixel) to enhanced transdermal delivery of tranexamic acid in treatment of melasma,fractional skin resurfacing system based on thermo-
mechanical ablation(Tixel) with application of normal saline solutionn as a placebo control arm
Experimental Device,Placebo Comparator Device
Tixel with tranexamic acid,Tixel with normal saline solution
Sponsors
Division of Dermatology, Department of Medicine, Faculty of Medicine, Mahidol University
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Female age 18-60 years 2. No underlying medical condition 3. Having similar melasma lesions on both sides of face 4. Not allergy to tranexamic acid 5. NO history of photosensitivity or heat intolerance 6. Capacity and agreement to comply to treatment and follow up protocol 7.Capacity to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy and breast feeding 2. Taking hormonal drugs or birth control pills within 1 year before treatment 3. Having light and laser treatment within 6 months before treatment 4. Using topical drugs for melasma or depigmented agents within 1 month before treament 5. Having rash or abnormal skin condition on face 6. Having cancer, hematologic disease, severe allergy, or serious systemic disease 7. Unwilling to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative lightness index (RLI) weeks 4, 8, 12, 16 Relative lightness index (RLI) = L normal skin - L Melasma | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified MASI score weeks 4, 8, 12, 16 mMASI = (darkness of pigment + homogeneity) x area | — |
Countries
Thailand
Contacts
Public ContactSalinee Rojhirunsakool
Unaffiliated
Outcome results
None listed