Efficacy of botulinum toxin A for the management of melasma: A split-face, randomized control study
Phase 4
Recruiting
- Conditions
- Clinical diagnosis of melasma with symmetrical involvement of both malar areasMelasma
- Registration Number
- TCTR20240721002
- Lead Sponsor
- Division of Dermatology, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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