Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos
NCT ID: NCT03386760
Last Updated: 2024-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2018-01-15
2022-07-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A- Ultra-Speed Picosecond laser
Utilisation of Ultra-speed Picosecond laser for tattoo depigmentation
Laser Utilisation PicoSecond
Laser utilisation for tattoo depigmentation
1 session every month for a total of 3 sessions
B- Nanosecond laser
Utilisation of Nanosecond laser for tattoo depigmentation
Laser Utilisation Nano-second
Laser utilisation for tattoo depigmentation
1 session every month for a total of 3 sessions
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Skin type I to VI
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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CHU de Nice - Dermatologie - Hôpital Archet
Nice, , France
Countries
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Other Identifiers
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17-PP-07
Identifier Type: -
Identifier Source: org_study_id
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