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Completed

NCT Number: NCT03386760

Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos

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.

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Key information

Conditions

Tattoo; Pigmentation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CHU de Nice - Dermatologie - Hôpital Archet

Nice, 06200, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser Utilisation PicoSecond

Device

Laser utilisation for tattoo depigmentation

1 session every month for a total of 3 sessions

Laser Utilisation Nano-second

Device

Laser utilisation for tattoo depigmentation

1 session every month for a total of 3 sessions

Primary outcomes

  1. 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

  1. Evaluation of Pain with EVA test

    Time frame: 2 months after one session of laser utilisation

  2. Evaluation of tolerance

    Time frame: 2 months after one session of laser utilisation

    correlation between EVA test and dermatological clinical signs

  3. satisfaction evaluation of depigmanetation tattoo

    Time frame: 2 months after one session of laser utilisation

    satisfaction tests

  4. Skin biopsies

    Time frame: immediately after treatment

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: PicoS

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2017
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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