The treatment of Acne Vulgaris with Variable Pulsed Light (VPL ) using the Energist Ultra VPL

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1 DOCUMENT_4_GRAM_ENGLISH 6/9/06 01:15 Page 1 The treatment of Acne Vulgaris with Variable Pulsed Light (VPL ) using the Energist Ultra VPL Dr. med. Gebhard E. M. Gramlich Chefarzt Privatklinik Hagenmühle GbR Hagenmühle, Seckach, Germany. Introduction 1. Definition of the disease Acne is a genuine illness of the skin predominantly affecting younger people. It is the oil rich follicle regions of the skin that are mainly affected and shows itself as a polymorphous clinical picture. The basis for acne lies in 4 pathogenic factors: Pathogenic factors of Acne Primary Factors Follicular hyperkeratosis Sebaceous hyperplasia Genetic Active Acne Outer influences for example, psychological Microbacteria hypercolonisation Inflammatory & immune response Secondary Factors 2. Epidemiology & Clinical state Acne exhibits the highest prevalence in puberty, where 80-90% of young people are susceptible. The maximum incidence of acne lies around years of age, affecting girls somewhat earlier than boys. Over and above the normal regressive period at years of age, persistent long term acne (Acne Tarda) can be seen occurring in both men and women into their 40 s. 3. Pathogenic factors Under the influence of androgens there is an increase of the sebocytes, with hyperplasia of the sebaceous glands, followed by hyper-seborrhoea and/or keratosis of the infundibulum of the hair follicle. It is well-known that both sebocytes as well as keratinisation of the infra-infundibulums can produce 5 A-Reductase ISO enzyme type I and 17 beta - Dehydroxysteroiddehydrogenase, which are both able to convert androgens. The increased lipid-secretion favours the growth of Propionibacterium of acne, which probably for the initial signs is not a necessary pathogenic factor, but only a secondary factor. By enzymes, e.g. the P. Acne bacteria - lipase, free fatty acids become split from triglycerides of the sebum, to which an irritative effect is attributed. Page 1 of 8

2 DOCUMENT_4_GRAM_ENGLISH 6/9/06 01:15 Page 2 Therapy Levels State of acne Table 1: State of Acne Decision for therapy (from Gollnick und Orfanos, 1993) Comedones Papules, Pustules Small nodules (< 1 cm) Nodules, Cysts, Fistules Inflammation Scarring I comedones < 20> < 10> none none none none II light papules, pustules III severe papules, pustules IV very severe (combination) Fistula comedones < 10> none medium none strong Yes Very strong and deep Yes During the clinical evaluation, no differentiation is accorded to primary non-inflammatory and inflammatory indications. Non-inflammatory: o Open comedone o Closed comedone Inflammatory: o Papules, Pustules, (Macula) o Nodules, In addition, secondary indications show: o Hemorrhagic crusts, cysts, Fistula comedones, drained sinus, scars. 4. Therapy Regime In principle, the treatment will depend on the severity level and the speed of acne development. Further, the therapy decision should depend on the skin type, sex, age, dermatology and nondermatology side-effects and the expected compliance as well as the private, social and vocational field. The therapy decision is dependent upon the dosage of medicine and will be differentiated as: topical mono therapy topical combination therapy systemic mono therapy systemic and topical combination therapy 5. Therapy Limitations Under no circumstances, is it the aim of the author to critically judge medicine therapy or conventional additives therapy procedures such as UV, acne washes, DADPS (Dapson) or Cryotherapy. However, each therapist when confronted with the therapeutic beginnings of the acne problem must make the best therapeutic decision. In addition, it must be determined clearly and critically that many of these therapeutic options for the patients are linked with relative "side effects", like social unattractiveness, limited effectiveness or violent skin reactions and irritations - for example, with topical solutions containing benzoyl peroxide. Oral antibiotics are very effective, however, the start of the desired therapeutic effect has very long lead times and such antibiotics must be taken continuously for long periods (>8 months). Besides, since 1979, increasingly the body trunk and patients with nodulocystic acne are documented to have antibiotic-resistant P. Acnes, as well as documented side effects. In general, this is a very highly effective medicine for severe acne, the Isotretinoin acts on the drainage of the skin and mucous membranes. However, severe side-effects such as visual disturbances, Page 2 of 8

3 DOCUMENT_4_GRAM_ENGLISH 6/9/06 01:15 Page 3 excessive cholesterol and possible depression, psychosis and acts of violence have been described which clearly limit their use. Due to the aforementioned effects it was clear that further therapeutic options were to be considered. Laser users over many years have knowledge and experience of lightbased phenomena and these associated reports allow new therapeutic paths to be taken. Alternatives Light-based Treatment Early inflammatory acne lesions are characterised by the pilosebaceous duct becoming infiltrated by Propionibacterium, a common cutaneous commensal. The improvement of acne lesions in individuals after exposure to sunlight is explained by the photosensitivity of the P. acnes bacterium which is a porphyrin-containing organism that is killed by exposure to specific wavelengths of light following the release of singlet oxygen species. With the highest sensitivity at 320nm (Near UV) with a secondary maximum at 415nm (blue). This corresponds to the absorption maximum of the porphyrins produced by P. Acnes, which are likely to act as chromophores. Therefore, irradiation of P. Acnes with light in the blue region could result in photodynamic stimulation of porphyrins stored in the bacteria leading to singlet oxygen production and bacteria death. Clinical research has established the photosensitivity of protoporphyrin. The absorption characteristics for protoporphyrin IX (PpIX) include significant absorption peaks at 508nm, 534nm, 578nm and 630nm. As blue light has been calculated to penetrate to less than 0.25mm in depth, thus it is unlikely to activate the porphyrins in the acne lesion. Consequently, longer wavelengths with a deeper penetration will be beneficial in the treatment of acne by exciting the porphyrins situated deeper within the acne lesion. It has also been hypothesised that light absorption by target cells also induces cell membrane permeability resulting in a proton influx and dissipation of ph gradients across the cell membrane. This effect, coupled with that of the singlet oxygen species induced by PpIX provides a micro-environment unsuitable for P. Acnes. Flashlamp pumped dye (FPDL) lasers at 585nm have been shown to produce a substantial reduction in the severity of acne infection over a 12-week period following a single treatment. The reported evidence and anecdotal experience of low-fluence pulsed-dye lasers which have been used for facial inflammatory acne provides a relevant basis for equivalent results to be expected when using high energy broad-band intense pulsed artificial light devices such as the Energist ULTRA VPL. As it has been reported that longer laser wavelengths (630nm, 670nm and 810nm) have also been successful in the treatment of acne, it is therefore reasonable to assume that the more deeply penetrating longer wavelengths of broadband light also achieve greater penetration depth to include reaching acne bacteria in the pilosebaceous duct. However, there is little evidence to suggest that any wavelengths over 810nm have any significant benefit. Page 3 of 8

4 DOCUMENT_4_GRAM_ENGLISH 6/9/06 01:15 Page 4 Use of ULTRA VPL in Acne Vulgaris Treatment As discussed above, there are several absorption peaks for PpIX which are covered by the output of broad-band light using a 530nm 950nm filter and will therefore provide a calculated aggregate of energy absorption in PpIX equal to or greater than that provided by the single wavelength FPDL laser at 585nm. VPL System Applicator Output 530nm - 950nm Normalised Max Intensity = 100% 100% 90% 80% 70% 60% 50% Ultra Vascular 40% 30% 20% 10% 0% Wavelength The Energist ULTRA VPL can produce filtered light in the range nm at energy densities over 50J/cm 2. Thus, energy delivered even below half-maximum output of the ULTRA at the peaks of PpIX absorption covered by the 530nm ULTRA VPL Applicator head will exceed 1.5 J/cm 2 across most of those significant absorption peaks listed above. With ULTRA VPL, both short (and potentially harmful) UV wavelengths and longer IR wavelengths (which might cause excessive tissue heating) are filtered out and an appropriate selection of micropulses in a longer pulse train ensures precisely dosed energy to target endogenous chromophores and provide optimum effectiveness in stimulating the body s own immune system response. The pulse selection is unique in that it allows for substantial cooling of the skin between each micro-pulse delivery of energy. This limits the pain associated with the treatment and subsequent side-effects. It has also been shown that post pulsed light treatment there is a stimulation of proteins leading to the increased production of collagen Type I & III and elastin. This can assist in the improvement of skin texture and rapid healing of the acne lesions. This may in turn lead to a reduction in the scarring associated with acne. Page 4 of 8

5 DOCUMENT_4_GRAM_ENGLISH 6/9/06 01:15 Page 5 Ultra Specification Light Source: Wavelength Range: Handpiece Waveguide: Handpiece Filter: Maximum Available Pulse Energy: Pulse Duration: Pulse Sequencing: Pulse Off Delays: Pulse Train Times: Repetition Rate: Treatment area: Energy Densities: Interface Control Panel: Electrical: Cooling: Single Flashlamp, Reflective Cavity, Filter 530nm Handpiece: 530nm 950nm 610nm Handpiece: 610nm 950nm BK7 Glass waveguide Cut-on Absorption filter 255J 3ms, 5ms and 7ms 2 15 pulses 1ms 20ms 7ms 385ms Up to 1 Hz 5cm 2 (5cm x 1cm) 530nm Handpiece: up to 51 J/cm2 610nm Handpiece: up to 45 J/cm2 (Energy densities accurate to ±20%) Full Colour LCD display with Touch-screen. Windows XP 100 Volts (6.5A) to 240 Volts (3.0A), 50/60 Hz. Continuous mode of operation Self contained, de-ionised water cooled Study Initiative The initiative for the study came from the need to find an optimal pain-free and non-combination therapy for the numerous acne patients in our clinic. Experiences with laser systems with wavelengths between 400 and 1068nm in other indications, shown above, showed positive effects with acne patients which encouraged us to use a light system for this treatment. The study is undertaken as a stand alone treatment option. In the period of September 2004 until February 2006, 31 patients with different stages of acne vulgaris were included in the study. With all patients acne-specific medications were stopped four weeks before beginning of the treatment with the VPL technology. No patient in the study was treated during the study duration with topical or systemic medicines. As for Home Care, only a cleansing fluid, a tonic and also a rehydrating care cream (Thalgo or La Roche-Posay) was supplied. The sex of the patients in the study were: Male - 12 (38.71%) Female - 19 (61.29%) The age of the patients lay between 16 and 50 years. With the following breakdown: 9 participants (29.03%) were between years of age, 15 participants (48.39%) were between years of age and 7 participants (22.58%) were years of age. Inclusion criteria for the study was a frustration or non-response to previous therapy with topical and systemic applications for acne vulgaris of the face at each severity level. Admission into the study: 3 participants (9.68%) in stage I, 18 participants (58.06%) in stage II, 8 participants (25.81%) in stage III and 2 participants (6.45%) in stage IV As graded using the Gollnick and Orfanos scale. Contraindications were: Keloid scarring or spontaneous keloids Taking roaccutane in the last 6 months Ideopathic photosensitivity Page 5 of 8

6 DOCUMENT_4_GRAM_ENGLISH 6/9/06 01:15 Page 6 Pregnancy Epilepsy Kaposi s Sarcoma and other pathologies in the treatment area Tattoos in the treatment area Fitzpatrick Skin type 2 patients = 6.5% of the study number were Fitzpatrick I 10 Patients = 32.26% Fitzpatrick II, 16 Patients = 51.61% Fitzpatrick III, 3 Patients = 9.68% Fitzpatrick IV, None of the patients could be classified as Skin Type V or VI Treatment Schedule The treatments were continued until significant patient satisfaction was reported, the frequency of treatments varied between 3 and 11. The treatment times were standardized with a minimum 14 days and a maximum of 4 weeks. Altogether with all patients 163 treatments were undertaken. This results in an average treatment frequency of 5.25 for each patient. During the 163 treatments, altogether 14,255 VPL shots were delivered, this corresponds to an average of shots for each treatment. Treatment Protocol On each treatment the whole face (Full Face) including the mouth, chin and the beginning of the neck region was treated. The 5x1cm Applicator of the ULTRA VPL with an overlap of 20% was applied sequentially with gentle pressure. Safety For ocular safety of the patient, dark green glasses (Shade 5, Glendale) were used. Preparation Great attention to detail for the exact preparation of the skin was undertaken with a deep cosmetic cleansing. Administration of anaesthesia with the ULTRA VPL was not necessary. Treatment Parameters The energy levels were selected according to areas of the face: Forehead: J/cm 2 average 22 J/cm 2 Cheeks: J/cm 2 average 20 J/cm 2 Nose and perioral: J/cm 2 average 19 J/cm 2 Mouth, chin & neck: J/cm 2 average 19 J/cm 2 The power densities were delivered in each case to a test spot in the area to be treated with initial power density, using the VPL multi-pulse procedure; on thriving acne with 5 micro-pulses, the micropulse time 3ms, pulse delay (= distance between the micro impulses) 2ms; on stabilized conditions with 8 micro-pulses, micro-pulse time 5ms, pulse delay 10ms. Before beginning the treatment session in the respective anatomical area test shots were applied. The respective patient was requested to articulate the subjective feeling, a light stinging feeling and/or a "pleasant" thermal sensation was to be tolerated, but treatment was never allowed to be painful. Objective criteria were the speed of the consequent erythema (under 10s, 10-30s, over 30s). If necessary a correction took place up or down. Before the actual treatment the entire area to be treated was covered with a colourless, particle-free cooling gel in a thin layer. The hair growth regions were protected with damp common saline-soaked compression. After treatment, the respective anatomical region was cooled with cold-packs, and after conclusion of the total procedure the entire face had a cool gel mask applied for approximately 5 minutes. Post-Treatment After conclusion of the treatment session rehydrating gel with a sun protection factor 15 was applied. The patients received a sun protective cream with SPF 15 to use following the week after treatment and instructed to avoid in this time unprotected UV exposure. Each study participant was monitored closely in follow-up to ensure there was no clinical deterioration. Page 6 of 8

7 DOCUMENT_4_GRAM_ENGLISH 6/9/06 01:15 Page 7 Side-Effects No patient of the study experienced any further side effects than the local brief erythema formation which can be expected (with 90% of the patients under 1h). Results With 19 patients (= 61.29%) it required an average of 4 treatments to achieve an 80% improvement of the symptoms and a reduction in classification of around 1.5 severity level in the Gollnick and Orfanos scale. 6 patients (= 19.35%) profited after on average 4 treatments from an improvement of at least 70%, further 5 patients (= 16.13%) from an improvement of at least 60%, both groups showed a reduction in the scale of at least 1 level. One patient (= 3.22%) had to break off because of further education and associated change of residence. After 3 treatments he was the only patient to achieve only a 50% improvement, but was nevertheless satisfied with the resultant outcome. Objectively, no patients were in the stages III and IV of the acne scale by the end of the study Improvement after 4 Tx 80% and more 70% and more 60% and more 50% and more Patient satisfaction The subjective evaluations of the treatment by the patient produced the following results: Patient observed feeling 22 patients = 70.97% judged the treatment from the feeling as very pleasant, 7 patients = 22.59% as pleasant, 1 patient = 3.22% as not unpleasant, and 1 patient = 3.22% as bearable. Patient observed results 20 patients = 64.52% judged the treatment result as very good, 8 patients = 25.81% as good, 2 patients = 6.45% as satisfying, and 1 patient = 3.22% as not completely satisfying. Everyone in the study would like to be treated with VPL again if required Very good Good OK Satisfactory 0 Results Page 7 of 8

8 DOCUMENT_4_GRAM_ENGLISH 6/9/06 01:15 Page 8 Summary In this self-initiated study, 31 patients with acne vulgaris of the face of different development and different severity level were treated by means of VPL light therapy. With an average frequency of approximately 5 treatments per patient and on average 87 delivered macro-pulses, significant improvements were achieved. Altogether 80.64% of the cases achieved at least 70% improvement of the symptoms % of the patients judged the result of the treatment as good and/or very good. Each of the test patients could be treated again at any time according to this method, showing this to be a gentle therapy, which was classified by 96.78% of those treated as extremely pleasant. The treatment with variable pulsed light is an outstanding method for the treatment of acne vulgaris at every level of severity. Since there is no contraindication, with a few exceptions, this opens up a broad application field for this therapy. When utilised correctly, this is a problem-free application which is practically pain free during and after the treatment, with an absence of side effects and rapid success. This therapy is important and valuable in the treatment of this dermatological complaint. To ensure a guaranteed treatment result it is imperative that the correct equipment is used and the therapist has a good basic knowledge. State of the art of pulsed light therapy is at present surely the ULTRA VPL system. Disclaimer: Energist Limited has endeavoured to translate the text to the best of their ability and with utmost care. While every effort is made to ensure the accuracy of the translation, due to the technical nature of this document, portions may be incorrect. Translation has been provided for those persons who do not speak German and is intended solely as a convenience. Any person or entity who relies on the information obtained from the document does so at his or her own risk. Page 8 of 8