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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03386760
Other study ID # 17-PP-07
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 15, 2018
Est. completion date May 2020

Study information

Verified date August 2019
Source Centre Hospitalier Universitaire de Nice
Contact Thierry PASSERON, PhD
Phone +33492036488
Email passeron.t@chu-nice.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
France CHU de Nice - Dermatologie - Hôpital Archet Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

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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