The Treatment of Acne Vulgaris using a Synchronous Intense Pulsed Blue Light and Radio Frequency Energy System

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1 The Aurora Acne Head The Treatment of Acne with the Aurora Acne Head The FotoFacial RF AC Unattractive skin, unwanted face or body hair and acne are the three most common undesirable skin concerns of patients seeking treatment in a medical spa environment, all of which can be treated using laser, IPL or Diode-RF, IPL-RF ELOS technology. We have focused intensely in this book on the art and science of the FotoFacial RF procedure. However, many patients present for FotoFacial RF treatments who are not good candidates because they suffer from moderate to severe acne. Very mild acne will often improve with FotoFacial RF treatment, but moderate to severe acne has a very high likelihood of getting much worse after a FotoFacial RF treatment. Approximately 30 40% of significant acne sufferers will have a large and unattractive papulareruptive acne outbreak after a FotoFacial RF treatment as the IPL-RF treatment causes some edema of the infundibulum of the pilosebaceous secretory duct, exacerbating any obstruction from a sebaceous plug that may exist and resulting in diminished sebum outflow, proliferation of Proprionium Bacterium Acnes in an ideal medium and a diffuse or regional papular eruption. For those patients suffering from acne who present for FotoFacial RF treatment, they must first enter our Aurora acne program prior to beginning the FotoFacial RF treatments. The Aurora Acne Head The Treatment of Acne Vulgaris using a Synchronous Intense Pulsed Blue Light and Radio Frequency Energy System Acne has been estimated to affect over 90% of the human population at some point in their lives. The pathophysiology of acne is multifactorial: a disorder of keratinization of the lining of the pilosebaceous unit, an overgrowth of Propionibacterium Acnes (P. acnes), hormonal factors and an overproduction of oil. Multiple treatments are available including topical treatments in the form of cleansers, creams, gels, lotions and masks. These topical treatments consist predominantly of salicylic acid, vitamin A/tretinoin, benzoyl peroxide and antibiotic formulations, which are designed to be mild keratolytics (acids and cleansers), decrease sebum or oil formation (Retin A), or be bacteriostatic or bacteriocidal (topical antibiotics and benzoyl peroxide). In addition, oral antibiotics and oral isotretinoin (Accutane) are also used in the treatment of moderate acne. The problem with topical antibiotics is inadequate depth of penetration to the level where the bacteria operate, and P. Acnes exhibit almost 70% resistance to oral antibiotics. X 36.1

2 On average the duration of time to achieve maximal effectiveness for topical and/or oral medications is 3 4 months. Many side effects are associated with traditional topical and oral therapies including skin irritation, erythema, chelitis, dry eyes, liver and renal abnormalities, anemia, leukopenia, lupus erythematosus, pseuduotumour cerebri, thyroid abnormalities, hypersensitivity reactions, fetal defects, diffuse skeletal hyperostosis, photosensitivity, irreversible night blindness, depression, hypertriglyceridemia and hypercholesterolemia. Aurora Acne Head IPL and Radio Frequency The newest innovation in acne treatment has been the emergence of blue light systems. Blue light, passive blue light systems, such as the ClearLight, emit a passive blue wavelength of light, between 400 nm and 420 nm. Blue wavelengths of light are longer than carcinogenic, harmful UV, but short enough to act as catalysts with phorphorins. Urophorphorins and corporphorins are produced by the P. Acnes and can be activated by blue light, Fig. 1. Aurora acne head. The blue light IPL cut-off is nm and, like the SR and DS heads, is positioned between the two RF electrodes. becoming unstable and producing oxygen free radicals, which then in turn are cidal for the bacterial. The problem with the passive blue light systems is that the passively emitted light and very short wavelength often cannot penetrate deeply enough to reach acne bacteria in nodular or cystic lesions. Thus, the passive blue light systems are generally only effective on mild, stage 1 superficial papular type acne (which is often successfully treated with the Aurora SR head alone). The Aurora acne head consists of a combination of short wavelength, intense pulsed blue light energy (IPL), similar to IPL (intense pulsed light) and radio frequency (RF) in the same pulse profile. The optical head of the Aurora acne head emits an intense pulsed blue light optical head and RF treatment head (fig. 1). The therapeutic advantage of the Aurora acne head over the ClearLight is the direct contact with the large spot size, all of which contribute to a deeper depth of penetration over passive blue light systems. The deeper depth of penetration means a more efficacious effect on the P. Acnes bacteria. This dual system acts on porphyrins through the short wavelength, blue light pulsed optical head (400 nm 900 nm), while the RF is theorized to cause sebaceous gland atrophy. The maximal IPL energy is 16 J/cm 2 (lower fluences as the short wavelength of light penetrates the dermis more superficially and the risk for superficial thermal injuries is slightly higher than with longer wavelength broadband light) and the maximal RF energy is 20 J/cm 2. The Aurora acne head is made even safer with its pulse sequencing, in that there is a maximum of 2J /cm 2 for each 2 ms pulse duration, then there is an obligatory 30 ms pulse delay and this continues until all the IPL fluence has been delivered. Thus, with the maximum IPL setting being 16 J/cm 2, it would require eight pulses of 2 ms each with seven interpulse delays, for a total pulse duration of 226 ms. X 36.2

3 This synergistic optical energy profile and radio frequency is effective in treating two key factors involved in the pathophysiology of acne vulgaris; P. Acnes and oil/sebum production. The short wavelength, blue light IPL flash lamp targets porphyrins produced by P. Acnes at the base of the pilosebaceous unit. The pulsed blue light stimulates the formation of coproporphyrinogens and uroporphyrinogens, which are chemically unstable. The result is destruction of P. Acnes in the pilosebaceous unit. The first big advantage of the pulsed blue light is that the direct contact of the head and higher relative fluences forces the blue light much deeper into the dermis. Second, the RF energy causes radiophotothermolysis and atrophy of the sebaceous gland and a subsequent decrease in oil production, where the bacteria actually live. This combined pulsed blue light and RF attack is much more effective on acne and can treat even nodulocystic eruptions (stage 1 to stage 4 acne). Thus, as a result of targeting both P. Acnes and the sebaceous gland, the Aurora acne head is a more potent and efficacious acne therapy than a passive, non-pulsed blue light source, i.e. the ClearLight, or a long pulsed YAG system targeting only the sebaceous gland, i.e. the Smoothbeam. Acne Classification 1. Stage 1 comedonal acne 2. Stage 2 papular acne 3. Stage 3 pustular acne 4. Stage 4 nodulocystic acne 5. Failure of ClearLight or other acne programs 6. Skin types 1 6 Indications and Contraindications Indications: for this dual combination therapy include acne vulgaris grades 1 4 (i.e. comedomal to nodulocystic), failure of passive blue light systems, such as ClearLight or other acne programs, skin types 1 6, and patients in whom systemic antibiotics or Accutane are contraindicated. Contraindications: include unrealistic expectations, Accutane use within three months of treatment, photosensitization disorders, collagen vascular diseases (such as lupus erythematosus, scleroderma, dermatomyositis, rheumatoid arthritis and mixed connective tissue disease), and pregnancy. X 36.3

4 FotoFacial RF AC Parameters: Initial and incremental settings Skin Type 1 IPL 10 J/cm 2 (Max IPL = 16 J/cm 2 ) RF = 10 J/cm 3 (increase IPL by 1 J/cm 2 each visit and RF by 2 J/cm 3 ) Skin Type 2 IPL 10 J/cm 2 (Max IPL = 16 J/cm 2 ) RF 10 J/cm 2 (increase IPL by 1 J/cm 2 each visit and RF by 2 J/cm 3 ) Skin Type 3 IPL 8 J/cm 2 (Max IPL = 16 J/cm 2 ) RF 8 J/cm 3 (increase IPL by 1 J/cm 2 per visit and RF by 2 J/cm 3 ) Skin Type 4 IPL 6 J/cm 2 (Max IPL = 12 J/cm 2 ) RF 6 J/cm 3 (increase IPL by 1 J/cm 2 per week and RF by 2 J/cm 3 ) Skin Type 5 IPL 4 J/cm 2 (Max IPL = 12 J/cm 2 ) RF 4 J/cm 3 (increase IPL by 1 J/cm 2 per week and RF by 2 J/cm 3 ) X 36.4

5 Skin Type 6 IPL 2 J/cm 2 (Max IPL = 12 J/cm 2 ) RF 4 J/cm 3 (increase IPL by 1 J/cm 2 per week and RF by 2 J/cm 3 ) FotoFacial RF Acne Treatment Protocol The treatment protocol is to treat the entire acne prone facial regions, not just active papules or pustules. The hand piece consists of an Aurora head, similar to the SR head, with contact cooling and containing an intense pulsed optical crystal of short, blue light wavelength, between two bipolar, conducted radiofrequency electrodes. Just as in the FotoFacial RF, it is important during treatment that optimal contact is made with the skin to deliver the RF energy and to deliver the available fluences of the optical energy safely, as the contact cooling hand piece reduces the risk of thermal injuries to the skin with the short wavelength of light emitted. Similarly, arcing is possible with the radio frequency current which can also result in overheating and burning. This treatment protocol targets sub-clinical sebaceous glands with high bacterial loads and results in sebaceous gland atrophy, even before the appearance of papules. Inflammatory papules and pustules are treated with a second or third pulse, in a non-stacked fashion. The pulsed nature of the device allows a greater depth of penetration than passive blue light systems, thus delivering the blue light to greater depths in the dermis. Aurora Acne Head Physics Each pulse emits a train of 2 J/cm 2 over 2 ms of IPL with wavelengths between 400 nm to 980 nm. The interpulse delay between each of these pulses is 30 ms. The RF pulse is a constant 320 ms pulse duration. The fluences from the short wavelength IPL head range from 2 16 J/cm 2 and the RF up to 20 J/cm 3. The number of pulses will depend upon the total amount of fluence entered, e.g. a 16 J/cm 2 setting would deliver eight pulses of 2 J/cm 2 and a total of six interpulse delays of 30 ms. The protocol calls for two treatments/week over four weeks for a total of eight treatments. Just like in a FotoFacial RF treatment, a test spot is performed first on each cheek. Look for erythema and, in skin type 1 3, the ISM% should be in the 15% range. With each visit, if there have been no complications, then you will increase the IPL by 1 2 J/cm 2 and the RF usually by 2 J/cm 3. Over the four week, eight visit treatment period, you most commonly witness a 70 80% clearance of papules to dry, potentially erythematous remnants. If there is a treatment failure, characterized by persistence of papules, then additional twice weekly treatments (usually four treatments over two weeks). Treatment is initiated at low IPL and RF fluences and increased, based upon skin type and response, weekly. X 36.5

6 Step 1. AcneFacial I: Similar to the FotoFacial RF, the entire acne prone regions of the face are treated with a first pass using the FotoFacial overlap technique. A test spot is done in front of each ear to ensure a good endpoint and should demonstrate slight erythema. The intial parameters for the AcneFacial I are outlined in the FotoFacial RF parameters table (see earlier in the chapter). The treatment might result in minimal to moderate discomfort. This can be eliminated with the use of a topical anesthetic cream applied 30 minutes prior to treatment and a topical chiller like the SynerCool. The duration of treatment is 30 minutes and can be delegated to a laser nurse or treatment technician (depending on your state laws). Step 2. AcneFacial II: Papulo-Pustular Treatment After the first pass over the acne prone regions, active papules and pustules are treated with a double or triple pulse, after the entire acne prone region of the cheeks, temples and chin have had an initial pass. At the end of the treatment, there should be very mild, generalized erythema. In regions of the skin that are more pigmented or over active papules and pustules more erythema might be present. Erythema usually lasts minutes; however, non-comedogenic makeup can be applied immediately after treatment. Acne Treatments on Non-Facial Areas The same two-step treatment protocol, with the same parameters, may be applied to other, nonfacial areas, most commonly the upper back in males. Maintenance Treatments Acne Vulgaris Grades 1 3 Acne 70-80% of papules resolve after six weeks and maintenance treatment decreases the frequency and severity of outbreaks by 50%. Acne Vulgaris Grade 4: Nodulocystic 50 60% of nodulocystic lesions resolve after six weeks and maintenance treatment decreases the frequency and severity of outbreaks by 30 40%. Acne is an inflammatory skin disorder responsive to a number of factors including hormones, stress and the environment. Because of this, unlike other skin lesions which are treated with lasers and resolve, acne may not be curable but can be controlled. Our findings for long-term acne control with the Aurora acne head are very similar to the use of Accutane. In our initial studies, 40 50% of patients who complete the full program appear to remain free over the long term (one or more years) of significant acne breakouts. Other patients achieve good long-term control, but have intermittent breakouts and will have a four-treatment, two-week bolus of acne head treatments to settle the outbreak. Other, more recalcitrant patients with require 1 2 treatments per month on an ongoing basis to maintain control. After the four weeks of treatment, patients with residual erythema, irregular texture, or acne scars may proceed directly into a formal FotoFacial RF program. X 36.6

7 Adjunctive Acne Treatments (i) Of course, oral and topical acne programs may be instituted and run concurrent with the Aurora AC head treatments. (ii) ALA Levulinic acid (ALA) the kera stik can be applied to the skin of selected acne patients minutes before a FotoFacial acne treatment. The ALA increases intracellular protophoryin 9 in the cells and can dramatically increase the selective photothermolytic and antibacterial effects of the treatment. (iii) Polaris WR head: The Polaris WR head is often used to treat active papular or nodulocystic regions of the acne form patient. The WR head improves chronically scarred acne skin, but also exerts a powerful high fluence RF effect on nodulocystic users and facilitates an atrophy of pilosebaceous cysts. Fig. 2. Nodulocystic patient treated with the FotoFacial RF AC head and protocol of eight treatments over four weeks. Almost complete resolution of active nodulocystic lesions. The now quiescent erythema and potential scars may be aggressively treated with the standard FotoFacial RF program. Expected Results It is important to give your acne patients a realistic expectation of outcome. Our initial acne head studies, using a split face comparison to no treatment on the control side, resulted in a 100% response rate. A reduction of new papules of 60 70% was seen after four weeks and this improved to 70 80% by six weeks and maintenance treatment was found to decrease the frequency and severity of outbreaks by 50% (Fig. 2). For residual erythema, hyperpigmentation or scarring, patients may then enter the 15-week FotoFacial RF programs after the eight-week acne program. X 36.7

8 Potential Acne Head Complications The Aurora acne head, despite short wavelengths of light, uses relatively low fluences with prolonged pulse sequencing and is thus very safe and relatively free of significant adverse reactions. However, there are some potential complications: Acute Complications Bullae rare (less than 1%) Hyperpigmentation or hypopigmentation (which in the absence of bullae is rare) Scarring there are no reports of scarring in our series to date Acute exacerbation of the acne 10 20% of all acne patients might experience a flare of acne before improvement, thus they must be informed of this risk Persistant erythema lasting more than the usual 90 minutes or less can occur Long-term Complications Scarring zero incidence Failure of treatment 20 30% of nodulocystic acne patients do not respond 10 15% of inflammatory acne patients do not respond For treatment failures, more treatments with progressively higher fluences are recommended, as well as adding a second to fourth pass (multiple AC head passes are more effective). Some recalcitrant patients may need more aggressive medical acne treatment, including Accutane. In general, complications are uncommon and most patients are able to return to normal activities immediately with no downtime. X 36.8

9 Conclusions On the basis of our series of acne patients treated with synchronous pulse optical blue light and radiofrequency energy we have witnessed the following observations: 1. A series of synchronous, intense pulse optical blue light and radiofrequency energy appears to provide significant reduction in active acneiform papules and pustules. 2. The intense pulse optical, direct contact and RF energy synergy appears to be effective on both stage 1 2, inflammatory-papular and more advanced nodulocystic acne vulgaris pathologies. 3. Long-term acne breakouts appear diminished in a large proportion of patients. 4. The treatments are very well tolerated and have very acceptable, negligible complication profiles. The use of this aggressive and successful pulsed IPL blue light and RF protocol is an ideal option for treating acne stage 1 4. The use of Accutane can be eliminated in many of these patients and they can segue immediately into formal FotoFacial RF treatments which will reduce the incidence of post acne inflammatory erythema, hyperpigmentation and scarring. The treatment protocol compares favorably with Accutane at this early juncture of investigation. X 36.9