Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos

NCT03386760 | Completed Phase 1

• 1 other identifier: 17-PP-07
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Tattoo; Pigmentation

Keywords

tattoo

Outcome Measures

Primary Outcomes (1)

• Percentage of decrease of tattoos 2 months after the third session as compared to baseline on standardized pictures

  2 month after the end of laser utilisation

Secondary Outcomes (4)

• Evaluation of Pain with EVA test

  2 months after one session of laser utilisation

• Evaluation of tolerance

  2 months after one session of laser utilisation

• satisfaction evaluation of depigmanetation tattoo

  2 months after one session of laser utilisation

• Skin biopsies

  immediately after treatment

Study Arms (2)

A- Ultra-Speed Picosecond laser

EXPERIMENTAL

Utilisation of Ultra-speed Picosecond laser for tattoo depigmentation

Device: Laser Utilisation PicoSecond

B- Nanosecond laser

ACTIVE COMPARATOR

Utilisation of Nanosecond laser for tattoo depigmentation

Device: Laser Utilisation Nano-second

Interventions

Laser Utilisation PicoSecond DEVICE

Laser utilisation for tattoo depigmentation 1 session every month for a total of 3 sessions

A- Ultra-Speed Picosecond laser

Laser Utilisation Nano-second DEVICE

Laser utilisation for tattoo depigmentation 1 session every month for a total of 3 sessions

B- Nanosecond laser

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Black tattoos with surface between 10 and 100 cm²
• Skin type I to VI

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Dermatologie - Hôpital Archet

Nice, 06200, France

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 29, 2017
• Study Start: January 15, 2018
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

FR (1)