Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Percentage of decrease of tattoos 2 months after the third session as compared to baseline on standardized pictures
Study Overview
Brief Summary
The investigators developed an ultra-speed picosecond laser (20ps) with a 20gHz repetition rate that provide very promising results in vitro and in ex vivo skin to remove skin tattoos.
The aim of this study is to evaluate the efficacy and tolerance of a new ultra-speed picosecond laser and to compare it to a nanosecond laser for treating black tattoos.
In a first phase of the study 10 patients with black tattoos will be treated with increasing fluencies of the picosecond laser to the optimal parameters in terms of efficacy and tolerance.
In a second phase, 10 additional subjects with black tattoos will be treated after central randomization on half of the tattoo with the picosecond laser (with the parameters determined in the first phase) and the other half treated with a nanosecond laser.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Black tattoos with surface between 10 and 100 cm²
- •Skin type I to VI
Exclusion Criteria
- •Childbearing age women
- •Active dermatosis located on the tattoo
- •Personal history of hypertrophic scars or keloids
- •Pigmentary or vascular lesions located on the tattoo
- •Subject taking oral steroid or retinoid or have any risk of delayed healing problems
- •Acquired or hereditary conditions that could leead to a delayed healing
- •Allergy to xylocaine, prilocaine or lidocaine
Arms & Interventions
A- Ultra-Speed Picosecond laser
Utilisation of Ultra-speed Picosecond laser for tattoo depigmentation
Intervention: Laser Utilisation PicoSecond (Device)
B- Nanosecond laser
Utilisation of Nanosecond laser for tattoo depigmentation
Intervention: Laser Utilisation Nano-second (Device)
Outcomes
Primary Outcomes
Percentage of decrease of tattoos 2 months after the third session as compared to baseline on standardized pictures
Time Frame: 2 month after the end of laser utilisation
Secondary Outcomes
- Evaluation of tolerance(2 months after one session of laser utilisation)
- satisfaction evaluation of depigmanetation tattoo(2 months after one session of laser utilisation)
- Evaluation of Pain with EVA test(2 months after one session of laser utilisation)
- Skin biopsies(immediately after treatment)