Clinical diagnosis of melasma with symmetrical involvement of both malar areas Melasma
Conditions
Interventions
The study was conducted using a split-face randomization method. One side of each patient'
s face received treatment with TCC alone (monotherapy).,The study was conducted using a split-face randomization method. The other side was treated with a combination of intradermal incobotulinum toxi
Active Comparator Drug,Experimental Drug
Monotherapy,Combined therapy
Sponsors
Division of Dermatology, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 62 Years
Inclusion criteria
Inclusion criteria: 1. Age more than or equal to 18 years 2. Clinical diagnosis of melasma with symmetrical involvement of both malar areas 3. Willingness to comply with the study protocol and follow-up visits
Exclusion criteria
Exclusion criteria: 1. Active skin infection or inflammation at the treatment sites 2. Open wounds at the treatment sites 3. Known allergy to study medications 4. Neuromuscular disorders 5. Uncontrolled acne vulgaris 6. History of recurrent herpes infection 7. Use of topical melasma treatments within 1 month or systemic/injectable treatments within 3 months 8. Facial procedures (laser, dermabrasion, peeling, radiofrequency, micro-focused ultrasound) within 6 months 9. Facial botulinum toxin injections within 6 months 10. pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of botulinum toxin A for the management of melasma Evaluation at 0, 2, 4, 8, 12, 16, 20 and 24 weeks Visia, Antera 3D, Colorimeter, MASI score on malar area (MASIm), GAIS score, and patient satisfaction | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of botulinum toxin A for a beneficial effect in melasma treatment and prevention of melasma recurrence Evaluation at 0, 2, 4, 8, 12, 16, 20 and 24 weeks Visia, Antera 3D, Colorimeter, MASI score on malar area (MASIm), GAIS score, and patient satisfaction | — |
Countries
Thailand
Contacts
Public ContactSasipim Chaijaras
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed