Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos

Phase 1

Completed

• Conditions: Tattoo; Pigmentation
• Interventions: Device: Laser Utilisation Nano-second; Device: Laser Utilisation PicoSecond

• Registration Number: NCT03386760
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-29
• Study Start: 2018-01-15
• Primary Completion: 2022-07-08
• Study Completion: 2022-07-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B- Nanosecond laser	Laser Utilisation Nano-second	Utilisation of Nanosecond laser for tattoo depigmentation
A- Ultra-Speed Picosecond laser	Laser Utilisation PicoSecond	Utilisation of Ultra-speed Picosecond laser for tattoo depigmentation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evaluation of tolerance	2 months after one session of laser utilisation	correlation between EVA test and dermatological clinical signs
satisfaction evaluation of depigmanetation tattoo	2 months after one session of laser utilisation	satisfaction tests
Evaluation of Pain with EVA test	2 months after one session of laser utilisation
Skin biopsies	immediately after treatment

Trial Locations

Locations (1)

CHU de Nice - Dermatologie - Hôpital Archet; 🇫🇷 Nice, France