Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos (PicoS)

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 2; Phase 1

Conditions: Tattoo; Pigmentation

Treatments: Device: Laser Utilisation Nano-second; Device: Laser Utilisation PicoSecond

Study type: Interventional

Funder types: Other

Identifiers

NCT03386760

17-PP-07

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

A- Ultra-Speed Picosecond laser

Experimental group

Description:

Utilisation of Ultra-speed Picosecond laser for tattoo depigmentation

Treatment:

Device: Laser Utilisation PicoSecond

B- Nanosecond laser

Active Comparator group

Description:

Utilisation of Nanosecond laser for tattoo depigmentation

Treatment:

Device: Laser Utilisation Nano-second