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Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos (PicoS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03386760
Recruitment Status : Unknown
Verified August 2019 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : December 29, 2017
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Tattoo; Pigmentation Device: Laser Utilisation PicoSecond Device: Laser Utilisation Nano-second Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: A- Ultra-Speed Picosecond laser
Utilisation of Ultra-speed Picosecond laser for tattoo depigmentation
 Device: Laser Utilisation PicoSecond

Laser utilisation for tattoo depigmentation

1 session every month for a total of 3 sessions
Active Comparator: B- Nanosecond laser
Utilisation of Nanosecond laser for tattoo depigmentation
 Device: Laser Utilisation Nano-second

Laser utilisation for tattoo depigmentation

1 session every month for a total of 3 sessions


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of decrease of tattoos 2 months after the third session as compared to baseline on standardized pictures [ Time Frame: 2 month after the end of laser utilisation ]

Secondary Outcome Measures :
  1. Evaluation of Pain with EVA test [ Time Frame: 2 months after one session of laser utilisation ]
  2. Evaluation of tolerance [ Time Frame: 2 months after one session of laser utilisation ]
    correlation between EVA test and dermatological clinical signs

  3. satisfaction evaluation of depigmanetation tattoo [ Time Frame: 2 months after one session of laser utilisation ]
    satisfaction tests

  4. Skin biopsies [ Time Frame: immediately after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386760


Contacts
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Contact: Thierry PASSERON, PhD +33492036488 passeron.t@chu-nice.fr

Locations
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France
CHU de Nice - Dermatologie - Hôpital Archet Recruiting
Nice, France, 06200
Contact: Thierry PASSERON, PhD    +33492036488    passeron.t@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03386760    
Other Study ID Numbers: 17-PP-07
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nice:
tattoo