Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos

Tattoo; Pigmentation Clinical Trial

— PicoS  

Official title:

Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03386760
• Other study ID #: 17-PP-07
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 15, 2018
• Est. completion date: May 2020

Study information

• Verified date: August 2019
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Thierry PASSERON, PhD
• Phone: +33492036488
• Email: passeron.t[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Tattoo; Pigmentation

Intervention

Device:
• Laser Utilisation PicoSecond
Laser utilisation for tattoo depigmentation 1 session every month for a total of 3 sessions
• Laser Utilisation Nano-second
Laser utilisation for tattoo depigmentation 1 session every month for a total of 3 sessions

Locations

Country	Name	City	State
France	CHU de Nice - Dermatologie - Hôpital Archet	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of Pain with EVA test		2 months after one session of laser utilisation
Secondary	Evaluation of tolerance	correlation between EVA test and dermatological clinical signs	2 months after one session of laser utilisation
Secondary	satisfaction evaluation of depigmanetation tattoo	satisfaction tests	2 months after one session of laser utilisation
Secondary	Skin biopsies		immediately after treatment