Evaluation of safety and efficacy of variable pulsed light in the treatment of unwanted hair in 77 volunteers

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1 J D V 0 Operat: Wang Duanyang Dispatch:.0.0 PE: Karyn Millar Journal Name Manuscript No. Proofreader: Chen Xiaoming No. of Pages: Copy-edit: Luisa J. Conti JEADV ISSN Blackwell Publishing Ltd ORIGINAL ARTICLE Evaluation of safety and efficacy of variable pulsed light in the treatment of unwanted hair in volunteers H Nahavandi, R Neumann, G Holzer, R Knobler* Department of Dermatology, Division of Special and Environmental Dermatology, Medical University of Vienna, Vienna, Austria Keywds hair removal, hypertrichosis, pulsed light, selective photothermolysis, variable pulsed light *Cresponding auth, Department of Dermatology, Division of Special and Environmental Dermatology, Medical University of Vienna, Währingergürtel 0, 00 Vienna, Austria, tel. xxxx; fax xxxx; robert.knobler@meduniwien.ac.at Received: May 00, accepted 0 May 00 DOI: 0./j x Introduction Abstract Unwanted hair growth is a common cosmetic problem f both women and men; mechanical and cosmetic improvement through elimination of the unwanted hair includes electrolysis (can be slow and painful, with efficacy rates of between % and 0% in long-term hair removal), shaving, laser epilation and chemical epilation (e.g. Eflnithine). In spite of the availability of numerous alternatives f hair removal, the management of this condition is often a significant challenge. Most methods f hair removal are associated with side-effects and a lack in efficacy., Pulsed light sources, commonly referred to as intense pulsed light (IPL), are devices that emit high-intensity polychromatic light. Their output is non-coherent in nature and delivers wavelengths across a broad spectrum from 00 to 00 nm. By placing appropriate filters over the light source, the specific wavelength of choice (dependent upon different indications) can be selected. In the majity of pulsed light systems, the energy is Background Several studies on hair removal with intense pulsed light (IPL) and various laser sources have been done, but adequate data on long-term follow up are scarce. The present uncontrolled prospective pilot study evaluated safety and long-term efficacy of variable pulsed light (VPL ) on hair removal in the face f medical and/ cosmetic indications. Study design/material and methods The VPL system (Energist Ltd, UK) was used f the treatment of hypertrichosis in the face, mainly hirsutism, in female volunteers. The minimum follow-up time after the last treatment was months (mean:. ±. months). Results Over 0% of hair clearance was observed in (.%) of all cases. Erythema and leucotrichia were the most often associated side-effects encountered. Transient pigmentary changes were not repted. Conclusion The VPL System presents as a relatively efficient and safe treatment alternative f long-term removal of unwanted hair. It seems to be particularly effective in fair-skinned patients with dark hair (skin types II III IV). Adverse effects were minimal and transient and, in no patient, significant enough to interrupt treatment. delivered in a single pulse by a fixed train of pulses, which may lead to unwanted side-effects. The variable pulsed light (VPL ) system delivers a pulse train of filtered visible light, in which each train can contain up to micro pulses. The unique properties of the VPL system lie in its ability to change the number, width and delay of the micro pulses in the train. These micro pulses of light ensure the target reaches its desired temperature with little effect on the surrounding tissue, thus reducing the incidence of pain and unwanted sideeffects. The VPL system is described as incpating a glass absption filter to allow output wavelengths in the range from 0 to 0 nm and a secondary water jacket to eliminate any water absbing wavelengths that may be present. This ensures that the treatment is me tolerable and minimizes non-specific thermal damage. VPL treatment of unwanted hair independent of indication is highly dependent on skin type and hair colour as well as hair coarseness. As is standard f these treatment fms, cooling is achieved by application of a layer of transparent cooled gel; thus, unwanted epidermal injury is 00 The Auths JEADV 00,, Journal compilation 00 European Academy of Dermatology and Venereology

2 XXXX Nahavandi et al minimized, particularly in dark-skinned individuals, and an increase of tolerance to treatment is achieved. The mechanism of hair removal by use of lasers, pulsed light and VPL is based on the principle of selective photothermolysis by targeting specific energy absbing molecules and/ ganelles called chromophes such as melanin. The melanin-containing melanocytes within the hair follicles absb light in a spectrum ranging from ultraviolet to infrared wavelengths, and the energy absbed by melanin is transfmed into heat that is capable of damaging the surrounding germinative cells., Hair in the anagen phase responds better to laser and IPL VPL treatment because of an increased concentration of melanin within the hair follicles. Because hair follicles in the catagen and telogen phase lack melanin, the possibility of light (energy) absption and subsequent heat generation is significantly reduced; the result is thus a reduced capability of follicular germinative cell damage with subsequent hair removal. Due to the lack of energy absbing chromophes, lasers, pulsed light systems and VPL are not able to induce removal of very light coloured white hairs., In some patients, reversible white/ clear hair re-growth after application of pulsed light VPL use f hair removal (leukotrichia) can occur. 0 The aim of this pilot study was to document our centre s clinical experience in the treatment of female volunteers with VPL f hair removal in different body sites with a range of delivered energies and a number of treatments. Materials and methods A total of consecutive female patients were included in the study and were evaluated f final statistical analysis. The Fitzpatrick skin types were distributed as follows:.% (n = ) were skin type II,.% (n = ) were skin type III,.% (n = ) were skin type IV,.% (n = ) were skin type V and.% (n = ) skin type VI. All volunteers were treated f excessive, generally male pattern hair growth in the face. None of these women was diagnosed as suffering from hyperandrogenamia syndrome of polycystic ovaries. Pri to VPL, patients (.%) repted having undergone pri laser hair removal with other light-based systems, such as the Ruby, Diode, Nd:YAG and Alexandrite lasers, with no evidence of long-term hair growth reduction. Patients with recent sun exposure and mild photosensitivity were not included. Pri to treatment, a signed infmed consent was obtained from all patients. Treatments were done with a VPL System (Energist Ltd, UK) consisting of a 0-nm hand piece; the spot size was cm cm. Pre-cooled optical coupling gel was applied generously befe treatments on the target area. The initial treatment settings were adjusted accding to skin type, pigmentation, hair colour and hair thickness. In der to gauge individual patient pain tolerance, the initial settings were set at the lower range of known effective fluence. The number of micropulses within the total pulse train varied between and 0 and was selected on patient tolerance and energy to be delivered to achieve perifollicular erythema. The width of each micropulse was selected, dependent upon the diameter of the treated hair with a -ms micropulse utilized f nmal to coarse hairs and a -ms micropulse f finer hairs. The delay between each micropulse was selected, dependent upon the skin colour of the patient. This ranged from to ms f light-skinned patients and up to ms f darker skin types. Treatments were generally repeated until no re-growth of hair in the treated area was observed and repted at the following visit, usually after a - to -week interval. The mean number of treatments per patient was. (range: ) treatments. The time interval between treatments was selected in accdance to the physiological aspects of the hair growth cycle (i.e. in the face, to weeks). Patients were instructed to stop shaving waxing weeks pri to the following treatment. The long-term efficacy of the treatment was evaluated clinically and by photographic documentation using the teach screen-moniting system (Foto-finder ; Germany). After months of minimum follow-up (mean:. ±. months), hair clearance was analysed by grading the response to treatment into four categies: Very good (loss of treated hairs: %) Good (loss of treated hairs: %) Moderate (loss of treated hairs: 0%) No response (loss of treated hairs: < %) The clinical grading was further substantiated by comparing pre- and post-treatment photographs. In addition, side-effects of the treatment, such as erythema, leucotrichia and hyperpigmentation and hypopigmentation, were evaluated after each treatment by the investigats. The Wilcoxon rank test was used f calculating statistically significant differences between the treatment response groups. Differences in distribution of qualitative patient characteristics (skin type, anatomic treatment location) accding to different treatment responses were assessed using a chi-squared (χ ) test. A two-tailed P-value of < 0.0 was considered significant. All statistical calculations were made with SPSS 0.0 f Windows (SPSS, Chicago, IL). Results Over 0% of hair clearance was observed in (.%) of all cases The overall treatment response after a follow-up of a minimum of months was as follows: Most of the patients 00 The Auths JEADV 00,, Journal compilation 00 European Academy of Dermatology and Venereology

3 Nahavandi et al. XXXX fig. Distribution of treatment results in facial areas (n = ) and relative distribution of the results accding to Fitzpatrick skin types II, III and IV: Patients with skin type III and IV generally demonstrated a better treatment response in the face than patients with skin type II. fig. Removal of facial hair with VPL: Befe treatment (a) and months after treatments (b). yielded a very good (n =,.%) good (n =,.%) long-term treatment response. Moderate long-term treatment response (hair clearance: 0%) was observed in cases (.%). No treatment failure was to be observed. There were no significant differences between the groups of very good and moderate response concerning mean energy levels (. ±. vs.. ±.) and mean treatment numbers (. ±.0 vs..00 ±.). Concerning patients characteristics, we observed that patients who showed a very good long-term treatment response were predominantly skin type III (n =, %; P < 0.0) and skin type IV (n =, %; P < 0.0), in comparison with patients with skin type II who prevailed in the group of moderate long-term treatment response (n =, %; fig. a). Mean age between the groups of very good and moderate treatment response did not differ significantly (P > 0.0). Adverse effects, such as scarring post-treatment pigmentary changes of the skin, were not observed under the treatment with the VPL System. Interestingly, 0 Colour image 00 The Auths JEADV 00,, Journal compilation 00 European Academy of Dermatology and Venereology

4 XXXX Nahavandi et al Colour image patients developed reversible leucotrichia. One patient also repted very sht lived small multiple follicular blisters in the abdominal area day after the treatment. Because these lesions resolved without any medication after a few days, they could not be identified by the investigats upon the planned return visit. Erythema was often seen immediately post-treatment but resolved within a few hours. The adverse effects were minimal and transient and in no case presented an indication f cessation of treatment. Discussion The concept of hair removal has recently been defined as a delay in hair growth, which usually lasts f to months, consistent with the induction of telogen hairs. Permanent hair reduction refers to a significant reduction in the number of terminal hairs after a given treatment regime, which is stable f a period of time longer than the complete growth cycle of hair follicles at the given body site. Recently, it has been suggested to add months to this post-treatment observation time. The period of observation of our patients was a minimum of months and with a significant difference noted in the time f the hair to re-grow. A number of patients who were observed f over year after the last treatment showed the same reduction in density, thus showing longterm efficacy. However, in a few patients, hair re-growth occurred after only months. The exact interpretation of these differences remains to be expled but may be directly related to the extent of thermal damage incurred by the hair follicle upon treatment. The hairs that did regrow were thinner and lighter, which to achieve better results required additional treatments at longer intervals. In subsequent studies, clinical evaluation should take into account not only hair count, but hair diameter reduction as well, as this has a significant clinical effect., Previously conducted comparable clinical studies evaluating the efficacy of similar IPL devices f depilation on much less study participants (n = n =, respectively) have repted a mean hair clearance months after the last treatment between % (two treatments, total fluence: 0 J/cm ) and % (mean treatment number:., total fluence: J/cm ). In our study (total energy fluence: 0 J/cm ), we observed a hair clearance of me than 0% in > % of the participants after months minimum follow-up (mean:. ±. months). Mean number of treatments (. ±.) in our study was higher, though. As f side-effects, the VPL system showed a high safety profile in our study., In our study, repeated increases in energy density of up to J/cm (maximum) without adverse effects of note were easily achieved. It thus seems that the VPL system used is extremely safe because the temperature rise in the hair follicle and surrounding tissue is slow., Conclusion The VPL system presents itself as an efficient and safe method f long-term hair removal. In addition, the VPL system was effective in a selected group of patients which included those who had previously failed other fms of treatment. The associated side-effects were minimal, so that non-e of the patients had to interrupt treatment. Additional longterm observations and controls, as well as application of repeat treatments at predetermined time intervals have shown efficacy in long lasting hair removal in this subset of patients. Based on these positive initial observations further prospective randomized studies are warranted. References fig. Detail view of facial skin treated with VPL: Befe treatment (a) and 0 months after treatments (b). Wagner RF. Physical methods f the management of hirsutismus. Cutis 0; :. Altman DJ, Huber F, Schrode K et al. Randomized double blind, vehicle controlled safety and efficacy evaluation of eflnithine % cream in the treatment of women. Poster presented at the th Annual meeting of the AAD. San Francisco, USA, The Auths JEADV 00,, Journal compilation 00 European Academy of Dermatology and Venereology

5 Nahavandi et al. XXXX Hatch R, Rosenfield RL, Kim MH, Tredway D. Hirsutism: implications, etiology and management. Am J Obstet Gynecol ; 0: 0. Andersson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absption of pulsed radiation. Science ; 0:. Raulin C, Greve B, Grema H. IPL technology: a review. Lasers Surg Med 00; :. Dierickx CC. Hair removal by Lasers and intense pulsed light sources. Dermatol Clin 00; 0:. Dierickx CC, Grossmann MC. Laser hair removal. In: Goldberg DJ, ed. Laser and Lights, Vol.. Elsevier Saunders, USA, 00:. Nanni CA, Alster TS. Laser-assisted hair removal: side effects of Q-switched Nd: Yag, Long-pulsed ruby and alexandrite lasers. J Am Acad Dermatol ; :. Tanzi EL, Lupton JR, Alster TS. Lasers in dermatology. Four decades Prog. JAAD 00; :. 0 Goldberg DJ. Laser Hair Removal UK. Martin Dunitz Ltd., 000. Dierickx CC. Hair removal by Lasers and intense pulsed light sources. In: Fitzpatrick RE, Goldman MP, eds. Cosmetic Laser Surgery USA 000: Mosby. Weiss RA, Weiss MA, Marwaha S, Harrington AC. Hair removal with a non-coherent filtered flashlamp intense pulsed light source Laser Surg. Medical ; :. Sadick NS, Shea CR, Burchette JL, Prieto VG. High-intensity Flashlamp Photoepilation: a clinical, histological and mechanistic study in human skin. Arch Dermatol ; :. Sadick NS, Weiss RA, Shea CR, Nagel H, Nicholsion J, Prieto VG. Long-term Photoepilation using a broadspectrum intense pulsed light source. Arch Dermatol 000; : 0. Goh CL. Comparative study on a single treatment response to long pulse Nd: YAG lasers and intense pulse light therapy f hair removal on skin type IV to VI is longer wavelengths lasers preferred over shter wavelengths lights f assisted hair removal. J Dermatolog Treat 00; :. Haedersdal M, Wulf HC. Evidence-based review of hair removal using lasers and light sources. J Eur Acad Dermatol Venereol 00; 0: The Auths JEADV 00,, Journal compilation 00 European Academy of Dermatology and Venereology

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