Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos

Conditions
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Tattoo; Pigmentation

Intervention / Treatment
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* Device: Laser Utilisation PicoSecond
* Device: Laser Utilisation Nano-second


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A- Ultra-Speed Picosecond laser<br>Utilisation of Ultra-speed Picosecond laser for tattoo depigmentation | Device: Laser Utilisation PicoSecond<br>* Laser utilisation for tattoo depigmentation 1 session every month for a total of 3 sessions<br>|
| Active Comparator: B- Nanosecond laser<br>Utilisation of Nanosecond laser for tattoo depigmentation | Device: Laser Utilisation Nano-second<br>* Laser utilisation for tattoo depigmentation 1 session every month for a total of 3 sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Pain with EVA test |  | 2 months after one session of laser utilisation | 
| Evaluation of tolerance | correlation between EVA test and dermatological clinical signs | 2 months after one session of laser utilisation | 
| satisfaction evaluation of depigmanetation tattoo | satisfaction tests | 2 months after one session of laser utilisation | 
| Skin biopsies |  | immediately after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tattoo