PFD patch decreases thermal exposure to tattooed skin

April 1, 2019

New research reports data on the effects the PFD patch has on thermal injury of the epidermis as well as airborne particle emissions.

Research has shown that the DESCRIBE perfluorodecalin (PFD) patch (Merz) can be used to safely and effectively enhance the tattoo removal process for patients by allowing multiple passes in a single laser treatment session.1 It has also shown that the patch improves treatment tolerability.2 However, research has yet to examine the effects the PFD patch has on thermal injury of the epidermis - until now.

Adding another layer to this growing body of research, Wojciech Danysz, Ph.D., Merz Pharmaceuticals, provided recent study data on the PFD patch and evaluation of thermal injury and plume, in a poster, at this year’s annual meeting of the American Academy of Dermatology (AAD) in Washington DC.3

PFD Patch Background
The PFD patch, which has been on the market since 2015, was initially FDA-cleared for use as an accessory to laser tattoo removal procedures using a 755 nm Q-Switched Alexandrite laser in Fitzpatrick Skin Type I-III patients. The patch received a new clearance in 2017, expanding to approved use with 532 nm, 694 nm, 755 nm and 1,064 nm standard Q-Switched lasers as well as 532 nm, 755 nm, 785 nm and 1,064 nm standard picosecond lasers in Fitzpatrick Skin Type I-III patients.

The PDF patch works by minimizing the time epidermal whitening remains on the laser treatment area. As a result, multiple passes during a single treatment session are possible, which can help to reduce the number of treatment sessions a patient may need for effective tattoo clearance.

“Every time you treat a tattoo, there is some epidermal whitening. That is the endpoint that we look for as the successful treatment of a tattoo. But when the epidermal whitening is present, it actually limits us from continuing the treatment because you are adding thermal damage while only minimally continuing to break down the tattoo ink,” according to Dr. Tsao, as reported by Dermatology Times in a previous article.4 

In 2017, Biesman and Costner demonstrated improved tolerability with the PFD patch in terms of patients having fewer and less severe adverse events related to epidermal injury compared with conventional laser tattoo removal treatment.2

Notably, published research has recently shown that use of the PFD patch with Q-Switched and picosecond lasers may be used safely and effectively in darker (Fitzpatrick IV-VI) skin types.5 Study authors performed a retrospective chart review in 14 patients (23 to 66 years of age) with Fitzpatrick skin types IV-VI who were treated with PFD patches and either the picosecond (532 nm, 785 nm and 1064 nm) or the Q-switched Nd:YAG (1064 nm). Tattoos included a wide range of ink colors ⏤ blue, black, red, green, purple and pink. No adverse effects were reported, according to the study authors who concluded that their review “supports the safety and efficacy of the PFD patch in protecting the epidermis from thermal injury during laser-assisted removal of multicolored tattoos in patients with Fitzpatrick skin types IV-VI.”

Enter the Merz PFD Patch Study
This latest study, according to the poster presented at this year's annual meeting of the AAD, was designed explicitly to evaluate thermal injury to the epidermis as well as airborne particle emissions.

In the study, 20 tattoos were created on dorsal pig skin. At day 16 post-tattoo, 40 sites (20 with, 20 without tattoos) were treated for 20 seconds (20 passes) per site with one of the following protocols:

Protocol 1: Skin + tattoo + PFD patch
Protocol 2: Skin + tattoo
Protocol 3: Skin + PFD patch
Protocol 4: Skin only

“We used Tattoolos® mobile desktop Q-switch laser Model YILIYA-MVII, Nd:YAG,” says Dr. Danysz. "The device was set at 1064 nm wavelength with a fluency of 600 to 800 mJ per 4 mm2.”

Results were determined via skin temperature measurements with the FLIR C3 thermal camera (FLIR Systems, Inc.). Air particle emission was measured using the condensation particle counter (CPC) 3007 (TSI Incorporated), with range of sensitivity (0.01-1 µm) and maximal particles number 100 000 applied, according to Dr. Danysz.

Each tattooed skin site treated with Protocols 1 and 2 showed visible discoloration (redness). None was observed for any non-tattooed skin site in Protocols 3 or 4. Skin treated with Protocol 1 (+PFD patch) resulted in a significant (40%) decrease in skin temperature compared with Protocol 2 (no PFD patch). With regard to plume, Protocols 1 and 3 (+PFD patch) resulted in less air particle emission, compared to Protocols 2 and 4, respectively. Results reached significance for Protocols 3 vs 4 (non-tattooed) and a 2-fold (nonsignificant) difference was achieved for Protocol 1 vs Protocol 2.

These reported results demonstrate that the PFD patch significantly decreases thermal exposure to the skin. The PFD patch also limits particle emissions into the air, according to data reported in the poster.

When asked about whether additional studies are forthcoming, Dr. Danysz says, “It’s always better to have more data, but [in this case] it is not necessary.” The data presented at AAD is being submitted for publication later this year, he says.

Disclosures:

Dr. Danysz is an employee of Merz Pharmaceuticals.

References:

  • Biesman BS, O'neil MP, Costner C. Rapid, high-fluence multi-pass q-switched laser treatment of tattoos with a transparent perfluorodecalin-infused patch: A pilot study. Lasers Surg Med. 2015;47(8):613-8.

  • Biesman BS, Costner C. Evaluation of a transparent perfluorodecalin-infused patch as an adjunct to laser-assisted tattoo removal: A pivotal trial. Lasers Surg Med. 2017;49(4):335-340.

  • Danysz, W. Evaluation of the Perfluorodecapin Patch for Laser Tattoo Removal in a Pig Model to Evaluate Thermal Injury Protection and Plume.” Poster. The Annual Meeting of the AAD. Washington DC: 2019.

  • Top 3 trends for tattoo removal. Dermatology Times. September 6, 2016. Available at: https://www.dermatologytimes.com/dermatology/top-3-trends-tattoo-removal Accessed April 1, 2019.

  • Vangipuram R, Hamill SS, Friedman PM. Perfluorodecalin-infused patch in picosecond and Q-switched laser-assisted tattoo removal: Safety in Fitzpatrick IV-VI skin types. Lasers Surg Med. 2019;51(1):23-26.