Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos

NCT ID: NCT03386760

Last Updated: 2024-07-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2022-07-08

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.

Detailed Description

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Conditions

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Tattoo; Pigmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A- Ultra-Speed Picosecond laser

Utilisation of Ultra-speed Picosecond laser for tattoo depigmentation

Group Type EXPERIMENTAL

Laser Utilisation PicoSecond

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

Laser Utilisation Nano-second

Intervention Type DEVICE

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

Intervention Type DEVICE

Laser Utilisation Nano-second

Laser utilisation for tattoo depigmentation

1 session every month for a total of 3 sessions

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nice - Dermatologie - Hôpital Archet

Nice, , France

Site Status

Countries

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France

Other Identifiers

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17-PP-07

Identifier Type: -

Identifier Source: org_study_id

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