A Single-Blinded, Randomized, Split-Face Study of Efficacy and Safety Using Low-Fluence Q-Switched Nd:YAG 1064 nm Compared to Fractional Picosecond Nd:YAG 532 nm in the Treatment of Melasma
Phase 4
Completed
- Conditions
- Melasma,all typesmelasma
- Registration Number
- TCTR20171130002
- Lead Sponsor
- Division of Dermatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
1. Age over 18 year-old
2. Presence of all types of melasma on both sides of face
3. Compatible with follow-up and treatment schedule
4. Informed consent
Exclusion Criteria
1. Pregnancy or on lactation periodตั้งครรภ์ ให้นมบุตร
2. Receiving oral contraception or replacement hormonal therapy within 1 year
3. Previously treated with energy-based devices within 1 months (for melasma)
4. Previously treated with topical anti-melasma or bleaching agents within 1 month
5. Presence of underlying autoimmune disorders
6. Presence of wound or severe cystic acne on face
7. Presence of pre-existing facial skin conditions
8. Severe underlying diseases
9. History of photo allergy
9. Withdraw
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mMASI (modified Melasma Area and Severity Index) Week 0, Week 2, Week 4, Week 6, Week 10, Week 14, Week 18 Photos taken with VISIA and evaluated by blinded dermatologists,Melanin index Week 0, Week 2, Week 4, Week 6, Week 10, Week 14, Week 18 Chromameter CR-200 Panasonic,Improvement score Week 10, Week 14, Week 18 Rating scale by blinded dermatologists and patients
- Secondary Outcome Measures
Name Time Method Adverse effects Week 0, Week 2, Week 4, Week 6, Week 10, Week 14, Week 18 Evaluated from patients and attending dermatologists,Patient satisfaction Week 10, Week 14, Week 18 Patients satisfaction rating score,Pain score Week 0, Week 2, Week 4, Week 6 Visual analogue scale