Comparison of 1064 nm picosecond laser alone and combination with fractional 1064 nm picosecond laser for tattoo removal
Phase 3
Completed
- Conditions
- Black tattoo on the body size from 1x1 cm to 10x10 cmMales and females aged 18ᇋ years-
- Registration Number
- TCTR20201027006
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. Healthy males and females aged 18-55 years with the presence of black tattoos on the trunk and extremities size from 1x1 cm to 10x10 cm
2. Fitzpatrick skin types III to V
3. Willing to participate in the study and signed the inform consent
Exclusion Criteria
1. Pregnancy or breastfeeding
2. History of overtattooing with colors other than black
3. History of keloid or hypertrophic scar
4. Performed laser treatments, dermabrasion, chemical peeling on tattooed skin within 6 months
5. Systemic retinoids within 6 months
6. History of photosensitivity
7. Skin infection around tattoo area
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tattoo clearance Week 0, 4, 8, 12 4 point scale tattoo clearance using standardized digital photographs
- Secondary Outcome Measures
Name Time Method Skin texture Week 0, 4, 8, 12 Antera 3D,Scar assessment Week 4, 8, 12 0= none, 1= mild, 2=moderate, 3=severe,PIH assessment Week 4, 8, 12 0= none, 1= mild, 2=moderate, 3=severe,Patient satisfaction index Week 4, 8, 12 0 dissatisfied, 1-25% slightly satisfied, 26-50% moderately satisfied, 51-75% very satisfied, 76-100,Pain score Week 0,4,8 VAS 0-10,Adverse effects Week 0,4,8,12 Physician and patients