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

August 9, 2019 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nice, France, 06200
        • Recruiting
        • CHU de Nice - Dermatologie - Hôpital Archet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 month after the end of laser utilisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Pain with EVA test
Time Frame: 2 months after one session of laser utilisation
2 months after one session of laser utilisation
Evaluation of tolerance
Time Frame: 2 months after one session of laser utilisation
correlation between EVA test and dermatological clinical signs
2 months after one session of laser utilisation
satisfaction evaluation of depigmanetation tattoo
Time Frame: 2 months after one session of laser utilisation
satisfaction tests
2 months after one session of laser utilisation
Skin biopsies
Time Frame: immediately after treatment
immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (Actual)

December 29, 2017

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17-PP-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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