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Tattoo Removal with Ultrafast Burst of Pulses: Phase I-II Prospective Study

32 Pages Posted: 28 Sep 2018

See all articles by Aurélie Lorgeou

Aurélie Lorgeou

Centre Hospitalier Universitaire de Nice

Florence Le Duff

Centre Hospitalier Universitaire de Nice; Université Nice Côte d’Azur

Nathalie Cardot-Leccia

Centre Hospitalier Universitaire de Nice

Romain Royon

Centre Hospitalier Universitaire de Nice

Romain Dubrasquet

Centre Hospitalier Universitaire de Nice

Jean-Philippe Lacour

Centre Hospitalier Universitaire de Nice

Thierry Passeron

Centre Hospitalier Universitaire de Nice - Service de Dermatologie; Université Nice Côte d’Azur

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Abstract

Background: Q-Switched laser in nano- or pico-second regime are actually the gold standard for tattoo removal. Despite the selective feature, the delivered power is important and these lasers have shown their limitations in term of efficiency, pain and side effects. We propose a new approach to avoid the energy levels used today. The objective of this study was to assess the tolerance and the efficacy of a laser delivering ultrafast burst of pulses for tattoo removal.  

Methods: A preclinical followed by a phase 1-2 prospective studies were performed on ex-vivo skin explants and on healthy subjects with black tattoos, respectively, using an ultrafast burst of pulses laser (35 ps, 4 MHz, 1064 nm) with cumulative fluencies of 2.5 to 50 J/cm². Efficacy was assessed on standardized pictures by two independent physicians. Pain during treatment was evaluated using a visual analogical scale. Histological examinations were performed immediately after the laser session and at two months.  

Findings: In the preclinical study, the treated explants presented no clinical sign of suffering. Histological analysis showed no damage in epidermis, dermis or hypodermis. In the first in man proof-of-concept study, 10 patients from skin type II to IV were included. The fluences of 10 and 50 J/cm2 have reduced the intensity of the pigment in 6 patients with a better decrease at 50 J/cm2. The average pain ranged from 0.4 to 2.75/10 depending on the fluences. Side effects were mild and only at the highest fluencies.  

Interpretation: We report here for the first time, the use of a new way to deliver the energy into the skin by emitting a burst of pulses to sum up the energy and decreasing the unwanted heating of the tissues. Our results show that such a technique provides very good tolerance and promising efficacy for removing tattoos.

Clinical Trial Number:  NCT03386760

Funding Statement: This study was supported by Irisiome©, France.

Declaration of Interests: RR and RD are employees of Irisiome© company

Ethics Approval Statement: IRB status: Accepted: 60-17 (Ile de France VI); ANSM (French Agency for Medicine Security) approval: Id-RCB : 2017-A02216-47

Keywords: Picosecond Laser; Ultrafast Burst of Pulses; Nd:YAG Laser; Tattoo Removal

Suggested Citation

Lorgeou, Aurélie and Le Duff, Florence and Cardot-Leccia, Nathalie and Royon, Romain and Dubrasquet, Romain and Lacour, Jean-Philippe and Passeron, Thierry, Tattoo Removal with Ultrafast Burst of Pulses: Phase I-II Prospective Study (August 29, 2018). Available at SSRN: https://ssrn.com/abstract=3244925

Aurélie Lorgeou

Centre Hospitalier Universitaire de Nice

Nice, 06200
France

Florence Le Duff

Centre Hospitalier Universitaire de Nice

Nice, 06200
France

Université Nice Côte d’Azur

INSERM U1065
Nice, C3M
France

Nathalie Cardot-Leccia

Centre Hospitalier Universitaire de Nice

Nice, 06200
France

Romain Royon

Centre Hospitalier Universitaire de Nice

Nice, 06200
France

Romain Dubrasquet

Centre Hospitalier Universitaire de Nice

Nice, 06200
France

Jean-Philippe Lacour

Centre Hospitalier Universitaire de Nice

Nice, 06200
France

Thierry Passeron (Contact Author)

Centre Hospitalier Universitaire de Nice - Service de Dermatologie ( email )

151, Route de Saint Antoine de Ginestière
Hôpital Archet 2
Nice, 06200
France

Université Nice Côte d’Azur ( email )

INSERM U1065
Nice, C3M
France

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