Melasma Melasma, hyperpigmentation, Abobotulinum toxin type A
Conditions
Interventions
In week 0, one side of the face will be randomly assigned using simple random sampling. Intradermal injection of Abobotulinum toxin type A will be performed on melasma lesions using a 32G needle, inse
Experimental Drug,Active Comparator Drug
Intradermal Abobotulinum toxin,Applying whitening serum
Sponsors
Chanisa Kiatsurayanon
Eligibility
Sex/Gender
Female
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Female 2. Aged between 18 to 59 years 3. In good general health 4. Fitzpatrick skin types II III or IV 5. Presence of epidermal dermal or mixed type melasma on both cheeks with relatively symmetrical distribution and dermoscopic examination showing no dark brown globules or globular like structures which may be observed in the early stages of exogenous ochronosis
Exclusion criteria
Exclusion criteria: 1. History of keloid tendency, severe inflammatory acne, infections (herpes, HIV, hepatitis B), skin cancer, allergic dermatoses, active facial infection/inflammation, open facial wounds, or neuromuscular/autoimmune disorders (e.g., Myasthenia gravis) 2. Current use of isotretinoin or use within the past 6 months 3. Current or recent (within 6 months) use of hormonal therapy or oral contraceptives 4. Use of topical melasma treatments within 1 month, or oral/injectable treatments within 3 months prior to the study 5. Pregnancy or breastfeeding 6. Bleeding disorders 7. Recent aesthetic procedures: botulinum toxin within 6 months, fillers within 2 years, or bio-regenerators within 2 years 8. History of facial procedures (e.g., laser, dermabrasion, chemical peeling, radiofrequency, or microfocused ultrasound) within 6 months prior to the study 9. Current smokers or those taking antioxidant supplements (including vitamin C) within 3 months before and during the study 10. Individuals with outdoor occupations or sun exposure >3 hours/day 11. History of hypersensitivity to botulinum toxin, FIOD whitening serum, or local anesthetics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Melanin index Week 2, 4, 8, 12, 16, 20 and 24 Mexameter,Modified melasma area and severity index for malar region scores (mMASI) Week 2, 4, 8, 12, 16, 20 and 24 3 dermatologists | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient overall satisfaction Week 2, 4, 8, 12, 16, 20 and 24 Patient overall satisfaction questionnaire,Side effects Week 2, 4, 8, 12, 16, 20 and 24 Questionnaire ,Elasticity Week 2, 4, 8, 12, 16, 20 and 24 Cutometer,Transepidermal water loss Week 2, 4, 8, 12, 16, 20 and 24 Tewameter,Wrinkles Week 2, 4, 8, 12, 16, 20 and 24 Antera 3D | — |
Countries
Thailand
Contacts
Public ContactKetsarapon Sanguanwuttitham
Institute of dermatology
Outcome results
None listed