Tattoo; Pigmentation Clinical Trial
— PicoSOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nice - Dermatologie - Hôpital Archet | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
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 |
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---|---|---|---|
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