Having achieved status as official distributor of the DESCRIBE® PFD Patch, Astanza is pleased to provide our clients with innovative technology promoting faster ink clearance, better laser access to ink, and safer treatment compared to tattoo removal without the Patch. For convenience, we’ve compiled a master list of Describe PFD Patch frequently asked questions.
I. BASIC OVERVIEW QUESTIONS
What is the DESCRIBE Patch?
The DESCRIBE PFD PATCH is a silicone patch infused with perfluorodecalin (PFD) that allows laser passes in a single tattoo removal treatment session and helps the laser reach ink particles deep within the skin.¹ ² The Patch allows up to 4x as many passes per office visit compared to treatment without the Patch.³
What is perfluorodecalin (PFD)?
Perfluorodecalin is a fluorocarbon often used in skin moisturizers. As a class, liquid fluorocarbons can dissolve a volume of gas up to 44% of their own volume.⁴ When plant leaves are immersed in PFD, they become transparent enough to read through.⁵
In trials, did patients prefer treatment with the DESCRIBE Patch?
Yes. In a recent clinical trial, patients reported less discomfort and faster healing with the Patch, ultimately reducing the time to clearance. In the same study, 100% of subjects given the option of completing treatment with or without the Patch chose the Patch.²
Who is a good candidate for tattoo removal with the DESCRIBE Patch?
Patients should consult with their doctor to see if they are a good candidate for laser tattoo removal. Treatment with the laser varies from patient to patient, depending on the age, size, type, and color of the tattoo. The color of the patient’s skin will also affect how effective laser tattoo removal will be.
Are there any side effects from using the DESCRIBE Patch?
The use of the DESCRIBE PFD Patch does not alter Potential Adverse Events from those encountered with the use of lasers alone. These potential adverse events may include pain, redness, and swelling. In a clinical trial, patients reported considerably fewer occurrences of each with the DESCRIBE Patch.⁶
How much does the DESCRIBE Patch cost?
The cost of the Patch can vary by physician and region. It is important to remember that when your doctor uses the DESCRIBE Patch, you’ll receive more laser treatment passes during each office visit. Since each visit is additional money out of your pocket and time out of your schedule, clearing your tattoo with the DESCRIBE Patch can offer significant benefits.
Are there any competitors for the DESCRIBE Patch?
The FDA-cleared DESCRIBE Patch is the only product of its kind on the market.
- Shah SD and Arangabadkar SJ. Newer Trends in Laser Tattoo Removal. J Cutan Aesthet Surg. 2015;8(1):25-29.
- Biesman B. O’Neil M. 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):613-618.
- Data on file, ON Light Sciences, Inc. Dublin, CA. 2015 (CSR DESCRIBE-01)
- F2 Chemicals. Dissolving gases in Flutec liquids. http://www.f2chemicals.com/pdf/technical/Gas20solubility.pdf. Accessed 5/1/2017.
- Littlejohn GR. Gouveia JD. Costner C, et al. Perfluorodecalin enhances in vivo confocal resolution of Arabidopsis thaliana mesophyll. New Phytologist. 2010;186:1018-1025.
- Data on file, ON Light Sciences, Inc. Dublin, CA. 2015. (510(k)).
II. ACCESSORY DEVICE QUESTIONS
What is the FDA-cleared indication for use of the DESCRIBE Ⓡ PFD Patch?
The DESCRIBE PFD Patch is indicated 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.¹
How is this device packaged?
The DESCRIBE Patch itself is composed of a dual-layer silicone polymer film infused with medical grade liquid perfluorodecalin (PFD). The PFD Patch is packaged in a heat-sealed transparent, gas-tight polymer pouch that contains surplus liquid PFD to permit pre-wetting of the skin prior to application of the Patch over the tattoo. This accessory medical device is packaged within a folded release liner, which is removed and discarded prior to use.³
What is the structure of the PFD Patch itself?
The upper layer of the patch is a thin low-friction membrane consisting of medical-grade silicone polymer. The upper layer serves as a barrier to mitigate evaporation of the PFD. The lower layer is a skin-contacting, medical-grade silicone polymer and is mildly tacky to promote adherence of the patch to the skin.³
What is “optical clearing” and how does it work?
PFD fills voids and wicks into porous tissue, which reduces light scattering. In addition, PFD also has the ability to dissolve gases, which also contributes to enhanced clearing of the opaque micro-bubbling.⁴
Why is the PFD Patch effective for use over human skin?
The refractive indices of both the silicone and PFD components of the PFD Patch closely align with that of human skin tissue. This is due to the PFD’s affinity for gases. Thus, the PFD Patch provides good optical index matching and optical coupling into the skin, and allows for the safe and unobstructed effective passing of laser light into the skin. In addition, PFD’s ability to reduce optical scattering on the skin’s surface, helps to improve energy delivery targeted at tattoo ink.⁴
Are there any health risks using PFD on the skin? Can it be absorbed through the skin?
PFD is metabolically inert and is not metabolized by the body in any way. PFD does not mediate, change, or induce a bodily response at the cellular or molecular level. It is both hydrophobic (does not dissolve in water) and lipophobic (does not easily dissolve in organic solvents, fats, or oils).³
Who can apply this PFD Ptch?
The PFD Patch can be applied by any HCP who is trained and able to provide laser-assisted tattoo removal in a given U.S. state. This is a medical device used as an accessory to laser for tattoo removal purposes. Use of lasers for tattoo removal and state-specific regulations relative to laser treatment administered by HCPs, must be determined by the HCP or the HCP’s supervising medical director when applicable.⁵
What lasers can be used with this PFD Patch?
The PFD Patch is only cleared for use with a Q-switched Alexandrite 755 nm laser in Fitzpatrick Skin Type I-III patients.²
What is the shelf life for the PFD Patch?
Each PFD Patch has an expiration date of 2 years from the point of manufacture. The expiration date is listed on the outside of the individual PFD Patch’s clear plastic packaging.³
Does the PFD Patch contain any latex?
The PFD Patch does not contain any latex. It is comprised of a medical-grade silicone polymer.⁴
What size is the Patch? Does it come in other sizes?
Currently, the Patch is provided in one size, approximately 2.5 x 3 in.
III. SAFETY-RELATED QUESTIONS
What are the treatment contraindications?
The PFD Patch is contraindicated for patients with dermatologic conditions that would disrupt the integrity of the skin in the area of application. Do not use on open wounds.¹
Are there any precautions using the PFD Patch as an accessory to laser tattoo removal?
Below are the listed precautions for the PFD Patch:¹
- For use only with a laser and settings selected by a trained laser operator.
- Single patient use only. Risk of cross-contamination. Do not reuse.
- Do not use if product is opened, damaged, opaque or visually defective.
- If the PFD Patch becomes darkened or opaque with ejected pigment, replace it with a fresh PFD Patch.
- Although the product is non-flammable, keep away from open flame.
- Wear protective gloves and safety glasses.
- Do not perform more than four laser passes per treatment session per treatment area.
Does the PFD Patch decrease laser treatment pain experienced by the patient?
Many practices find that the epidermal protection offered by the PFD Patch during laser treatment may help decrease pain during the procedure. Patients have reported less pain and shorter healing time.²
Will use of the PFD Patch result in unusual adverse events?
Use of the PFD Patch does not alter potential adverse events typically seen from lasers alone, such as redness, swelling, pigmentary changes, infection, scabbing, scarring, crusting, bruising, itching, flaking, or blistering. Data from the clinical studies suggest the frequency of some of these adverse events were reduced with use of the PFD Patch, as compared to treatment with laser alone.¹
What if an HCP asks why the Patch has a wavy appearance? Does that mean I have a defective product?
No, the wavy appearance is a physical property of the Patch.
If the practice needs further clarification, then the following response would suffice: “This is a cosmetic property and does not impact the safety and efficacy of the Patch.”
You should then recommend the practice to watch the instructional video on DescribePatch.com to see the proper technique for product use.
IV. TREATMENT-RELATED QUESTIONS
What are the pre-treatment and post-treatment care protocols when using the Patch?
The pre-treatment and post-treatment protocols do not alter from conventional laser treatment when using the Patch. The practice is encouraged to provide pre- and post-treatment care in accordance with their standard operation procedure.
How many Patches can I use in one treatment session?
The patch is single-patient use and should be discarded at the completion of a tattoo removal session. You can use multiple Patches on a single patient, up to two Patches on the same treatment area.¹
Why is it important to use the highest tolerated fluence?
Recalcitrant ink tends to reside deeper in the dermis, typically requiring a higher fluence with conventional treatment. PFD allows for potentially an even higher tolerated fluence to be used in order to attain deeper penetration (where recalcitrant ink is found), without resulting in additional side effects.⁴
I still see whitening when I use the PFD Patch. Why?
Whitening, also known as micro-bubbling on the skin, can still occur with use of the PFD Patch. However, application of liquid PFD helps to clear this whitening within minutes. This efficient clearing allows the HCP to perform multiple passes quickly and safely. Applying additional PFD liquid from the pouch using the provided swab after whitening occurs may assist in clearing this even more quickly.² ³
What is this dark “smudging” that sometimes occured? (Ink ejection)
Sometimes, dark smudging will appear after the laser is fired. This is believed to be ink ejection into the PFD Patch. Avoid treating through a dark (i.e. smudged) area. To continue treatment, either reposition the Patch to an optically clear area or use a new Patch.³
What are the clinical endpoints if I do not see whitening?
The clinical endpoints should be the same as when treating without a patch. If whitening does not occur with use of the PFD Patch, you may need to titrate the fluence upwards to achieve the desired clinical whitening.²
Are there additional benefits to using the PFD patch other than increased number of treatment passes per session?
The PFD Patch can make the laser tattoo removal procedure safer and more effective for the patient in several ways:¹ ² ⁶
- The provider is able to treat the patient at the maximum tolerated fluence, and multiple passes can be safely performed over a short period of time.
- The PFD Patch may help to reduce laser scatter, as well as enhance HCP and patient safety. Use of the PFD Patch may help provide the surrounding tissue with added thermal protection, potentially minimizing epidermal damage.
- We have observed the PFD Patch may help improve post-procedure healing. Accelerated healing can increase patient compliance by decreasing time between treatment sessions or minimizing delays in treatment due to prolonged healing.
- A reduction in the potential laser-generated airborne contaminants that can carry harmful chemicals has been noted by providers during treatment, which may lead to a safer environment for both the provider and the patient.
- PFD Patch Instructions for Use (IFU) document.
- Beisman BS, COster C. Q-switched laser treatment of tattoos using a transparent perfluorodecalin-infused patch. Laser Surg Med. 2017
- Merz Data on File
- Biesman B, O’Neil M, Costner C. Rapid, High-Fluence Multi-Pass Q-Switched Laser Treatment of Tattoos With a Transparent Perfluorodecalin-Infused Patch: A Pilot STudy. Laser Surg Med. 2015;47(8):613-618.
- Governing State Boards of Medicine & State Boards of Nursing.
- Bargman H. Laser-generated airborne contaminants. J Clin Aesthet Dermatol. 2011; 4(2):56-57.