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Selective_sebaceous_gland_electrothermolysis_as_a_.pdfSelective sebaceous gland electrothermolysis as a treatment Jin W. Lee1, MD, Beom J. Kim1, MD, PhD, Myeung N. Kim1, MD, PhD, and Although many therapeutic options exist for acne, relapse often occurs after treatment is stopped. Some preliminary evidence suggests that selective electrothermolysis of the seba- ceous glands may represent a novel therapeutic intervention. This trial was conducted to evaluate the efﬁcacy and tolerability of selective sebaceous gland electrothermolysis for the treatment of facial acne. Twelve patients with facial acne were enrolled, all of whom under- went three sessions of therapy. During each session, a 1.5-mm-long needle with 0.45-mm of base insulation was inserted into pores of acne lesions. Upon insertion, a high-frequency electrical current was applied for 0.25–0.50 s, for a total output of 40 W. Each treatment session took approximately 30–60 min. Subject response to therapy was evaluated at 1 month and 12 months after the ﬁnal treatment. All the enrolled subjects completed the study and all reported satisfaction with treatment results. In all cases, a reduction in inﬂam- matory and non-inﬂammatory lesion counts was observed after three sessions of selective electrothermolysis, although a few small papules and comedones persisted in several areas of untreated facial skin. Mean lesion reduction at 1 month after the ﬁnal treatment was 98.14% for inﬂammatory lesions and 83.09% for non-inﬂammatory lesions. Clinical success was achieved in the majority of patients (seven of 12 patients) at 1 month after the second treatment, and in all patients at 1 month after the ﬁnal treatment. All patients reported transient post-treatment erythema, which faded after a few days. Clinically evident relapse occurred in two of 12 patients (16.7%) 1 year after the ﬁnal treatment session.
Selective sebaceous gland electrothermolysis can be a safe and effective method of achieving consistent remission in acne.
therapeutic options for acne vulgaris, relapse is common after treatments are stopped, although relapse rates after Acne vulgaris is a chronic inﬂammatory disease of the isotretinoin treatment are relatively low if the drug is pilosebaceous units, which is characterized by comedones, administered at the correct dose for the correct period.
papules, pustules and nodules, and often results in signiﬁ- However, because of side-effects such as mild cheilitis cant facial scarring. Epidemiologic studies estimate that (dryness of lips), mild xerosis, epistaxis, as well as eleva- as many as 80% of individuals between the ages of tion of serum glutamic oxaloacetic transaminase (SGOT), 11 years and 30 years are affected by this common condi- serum glutamic pyruvic transaminase (SGPT), cholesterol tion. The pathogenesis of acne is deceptively complex: and triglycerides, some patients have difﬁculty in comply- seborrhea, abnormal pilosebaceous duct corniﬁcation, ductal colonization with Propionibacterium acnes and Preliminary evidence suggests that selective electro- secondary inﬂammatory processes are all implicated in thermolysis of the sebaceous glands using the method the underlying etiology. As well as the obvious facial dis- proposed by Kobayashi and Tamada3 may represent an ﬁgurement, acne is also associated with signiﬁcant psy- additional therapeutic option for facial acne. We under- chological morbidity, including emotional debilitation, took this study to evaluate the efﬁcacy and tolerability of embarrassment, poor self-esteem and social isolation.
this modality. In a 1-year follow-up evaluation, we also Accordingly, an ongoing need for quality medical attempted to quantify the rate of recurrence in treated resources and treatments exists.1 Although there are many ª 2011 The International Society of Dermatology International Journal of Dermatology 2011 Sebaceous gland electrothermolysis in acne those used in the preceding session. Complete lesion counts and subject response rates were assessed 1 month after the ﬁnal treatment. Subjects were also evaluated for remission This was a prospective pilot study. Twelve Korean patients with rates 1 year after the ﬁnal treatment. All subjects were moderate to severe facial acne [according to Investigator’s prohibited from using any anti-acne treatment (except for 2 Global Assessment (IGA) scores] (Table 1) were enrolled. All standard washing and moisturizing procedures) while enrolled subjects had Fitzpatrick skin types III–V. Exclusion criteria included any use of oral antibiotics or isotretinoin for the treatment of acne within the previous 6 months, use of topical or systemic antibiotics within the previous 2 weeks, and The patients were photographed at each visit. On each pregnancy or lactation in female subjects. Additionally, women occasion, subjects were photographed by the same using hormonal forms of contraception with anti-androgenic photographer in the same position, using identical camera and properties for <12 weeks were precluded from enrolling. The lighting settings. To evaluate efﬁcacy, two variables were used: mean age of the subjects was 24.6 ± 3.4 years (range: 20– overall success rate (deﬁned as the percentage of patients 32 years). The group consisted of six women and six men.
rated as ‘‘clear’’ or ‘‘almost clear’’ on the IGA), and net change Table 2 summarizes participant demographics. The study was in the number of facial acne lesions. All lesion counts included approved by the Institutional Review Board of Chung-Ang both inﬂammatory (papules, pustules, nodules) and non- University Hospital. Written informed consent was obtained inﬂammatory (open and closed comedones) lesions. Lesions from all patients prior to treatment.
were assessed on the face only. At each visit, a blinded physician counted the number of facial acne lesions on each subject’s face. This same blinded physician also assessed the Before treatment, each subject’s face was gently cleansed with overall success rate before each treatment and 1 month after a mild cleanser prior to the application of a topical anesthetic the ﬁnal session and documented any side-effects. At the end 3 cream (EMLAÒ; AstraZeneca Pharmaceuticals LP, Wilmington, of the study, subjects were asked to rate their level of DE, USA). After 30 min, the anesthetic was removed and the satisfaction with the ﬁnal results of the treatment on a 4-point subject was asked to adopt a supine position prior to the scale (4 = very satisﬁed, 3 = satisﬁed, 2 = slightly satisﬁed, initiation of treatment. Throughout the duration of the 1 = unsatisﬁed). One year after the last session, all subjects procedure, ·2 to ·3 magnifying lenses were used by study returned for a ﬁnal follow-up evaluation at which treatment- personnel. Acne lesions (comedonal acne lesions and speciﬁc recurrence was assessed. Speciﬁcally, any treated inﬂammatory acne lesions) were identiﬁed, the surrounding skin patient in whom acne was rated as ‘‘mild,’’ ‘‘moderate,’’ was stretched and a 1.5-mm-long needle with a 0.45-mm base ‘‘severe’’ or ‘‘very severe’’ on the IGA was considered to have insulation was inserted into the center of the lesional follicular suffered a relapse. Treatment effects were determined based pore at an angle of 60–70° (Fig. 1). Using an electrosurgical on statistical analysis using the Wilcoxon signed rank test to apparatus (IME-HR 5000; IME Co. Ltd., Tokyo, Japan), a high- compare lesion counts at each follow-up visit with baseline frequency current was then applied for 0.25–0.50 s at an counts. A P-value of <0.05 was considered to indicate statistical intensity of approximately 40 W. Treatment duration was about 10 min per 10 lesions treated. The day after the procedure, the contents of the comedo or inﬂammatory lesion (e.g. pus) were expressed by applying gentle pressure. All subjects underwent a total of three treatment sessions at 1-month intervals. During All subjects completed the study and all showed a reduc- the second and last treatments, the operator deliberately tion in inﬂammatory and non-inﬂammatory acne lesions inserted the needles in directions that differed slightly from after three selective electrothermolysis treatments. Clinical Table 1 Investigator’s global assessment Residual hyperpigmentation and erythema may be present A few scattered comedones and a few (<5) small papules Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules More than half of the face is involved. Numerous comedones, papules and pustules Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts Highly inﬂammatory acne covering the face; nodules and cysts are present International Journal of Dermatology 2011 ª 2011 The International Society of Dermatology Sebaceous gland electrothermolysis in acne side-effect was transient erythema at the sites of treated lesions. The inﬂammatory content (pus) released by gentle pressure spread to the surrounding tissue, inducing ery- thema and further inﬂammation. Although this occurred in all subjects, the redness typically faded within several days and seldom persisted for a week. Other severe adverse events – such as pigmentary alterations, scarring and infections – were not reported. One year after the ﬁnal treatment, two of 12 patients (16.7%) were found to have relapsed. However, in both cases, the acne was rated as Lloyd and Mirkov4 ﬁrst reported selective sebaceous gland photothermolysis as an effective treatment for acne.
These authors employed a long-pulse diode laser with a Figure 1 In selective electrothermolysis in the treatment of wavelength of 810 nm to destroy enlarged sebaceous acne, a ﬁne needle with an insulated coating is inserted into glands preloaded with indocyanine green chromophore.4 the center of the follicular oriﬁce and used to deliver an electrical current, after which an extractor is used to remove Kobayashi and Tamada3 demonstrated that selective seba- ceous gland electrothermolysis is a safe and effective ther- apeutic option for facial seborrhea. They also showed that a decreased number of sebaceous glands and the for- examples are shown in Figs 2 and 3. One month after the mation of ﬁbrosis were observed after selective sebaceous ﬁrst treatment, the mean reduction in acne lesions was gland electrothermolysis in a preliminary histologic 59.20% for inﬂammatory-type lesions (P < 0.01) and study.3 Together, the results from these studies suggest 48.64% for non-inﬂammatory lesions (P < 0.01). One that this technique may represent a new therapeutic month after the second treatment, the mean reduction in acne lesions was 82.96% for inﬂammatory lesions Here, we show that selective sebaceous gland electro- (P < 0.01) and 69.79% for non-inﬂammatory lesions thermolysis effectively treats acne; all our subjects (P < 0.01). One month after the ﬁnal treatment, the mean reported satisfaction with the treatment in their self- reduction in acne lesions was 98.14% for inﬂammatory assessment surveys. Other than transient erythema and lesions (P < 0.01) and 83.09% for non-inﬂammatory mild dryness, no adverse events were observed in any of lesions (P < 0.01). In terms of the overall success rate, the subjects. Our data also indicate a low relapse rate clinical success was achieved in the majority of patients after this speciﬁc therapy: only a few tiny papules or com- (seven of 12 patients) 1 month after the second treatment edones were observed in untreated areas of skin in a few and in all cases at 1 month after the ﬁnal session.
patients. We also presume that more than three treatment Figures 4 and 5 illustrate progressive changes in numbers sessions (probably at least four or ﬁve sessions) will be of inﬂammatory and non-inﬂammatory lesions from base- required in very large cystic lesions to completely destroy line. Of the 12 patients, one (8%) reported being ‘‘slightly all associated sebaceous glands as most recurrences satisﬁed’’ with the treatment, four (33%) reported being occurred in the treatment zones of the largest acne ‘‘satisﬁed’’ and seven (59%) reported being ‘‘very satis- lesions. We attribute our results to the permanent reduc- ﬁed.’’ The mean score for patient satisfaction was tion in sebum excretion achieved by selective electro- 3.50 ± 0.67 (out of 4). The most common reported thermolysis through the precise destruction of hyperactive ª 2011 The International Society of Dermatology International Journal of Dermatology 2011 Sebaceous gland electrothermolysis in acne ﬁnal treatment, and (d) at 1 year after ment, (b) at 1 month after the ﬁrst treat- treatment, and (d) at 1 year after the last sebaceous glands by electrical heat.3 Reducing the pro- our study. This reliable, strong insulation permitted us to duction of sebum, which is a medium for bacteria use electrical power at a voltage sufﬁciently high to elimi- growth, is helpful for normalizing Propionibacterium ac- nate the target tissue without damaging the surface of the nes hypercolonization. It is also possible that this inter- vention-induced heat extended to the thermal destruction Because this study is not a comparison study, it is of bacteria.4 Moreover, the development of new technol- impossible to directly compare the efﬁcacy of this treat- ogy, which allowed for very tight adhesion between the ment with that of other treatments. However, selective short, thin needle and insulating material, was critical to electrothermolysis has some notable advantages over International Journal of Dermatology 2011 ª 2011 The International Society of Dermatology Sebaceous gland electrothermolysis in acne other acne treatments. Most conventional topical agents blue and red light sources.11–15 However, the therapeu- – including antimicrobials, retinoids and anti-inﬂamma- tic efﬁcacy of these modalities is limited and relapse is tory agents – must be applied daily for several weeks common after these treatments are stopped. As selective before any effect is seen, and most are associated with electrothermolysis results in the permanent destruction some degree of skin irritation.2,5–7 Similarly, many of of treated sebaceous glands, it is associated with a low the conventional oral medications used in treating acne relapse rate. Additionally, this intervention achieves – including antibiotics, oral contraceptives and retinoids therapeutic efﬁcacy in only two or three treatment ses- – have signiﬁcant portfolios of side-effects, including, sions. Unlike photodynamic therapy, selective electro- but not limited to, gastrointestinal upset, antibiotic thermolysis does not require patients to avoid sun resistance, thromboembolic events and teratogenicity.2,8– exposure for 48 h after treatment and can be used in By contrast, selective electrothermolysis performed by properly trained therapists has not been associated with In conclusion, our results suggest that selective electro- any severe side-effects. As this method is not a systemic thermolysis is clinically effective for the treatment of acne treatment, many of the intrinsic problems associated and that it is associated with minimal complications.
with the current acne regimens (e.g. patient compliance Although few studies have fully described this treatment, and associated side-effects) are not applicable. More we contend that selective electrothermolysis represents recently, optical treatments have been introduced as another effective treatment modality that supports consis- alternative treatments for acne, including pulsed dye tent remission in acne. However, as this is a small study, lasers (PDLs), infrared diode lasers, radiofrequency additional, larger studies are needed to fully evaluate this devices, intense pulsed light (IPL), and broad-spectrum ª 2011 The International Society of Dermatology International Journal of Dermatology 2011 Sebaceous gland electrothermolysis in acne randomized, controlled multicenter study. Arch DermatolRes 2007; 299: 467–473.
The authors of this study would like to express their sin- 10 Eady EA, Gloor M, Leyden JJ. Propionibacterium acnes cere condolences to the family of the late Dr Toshio Ko- resistance: a worldwide problem. Dermatology 2003; 11 Seaton ED, Charakida A, Mouser PE, et al. Pulsed-dye laser treatment for inﬂammatory acne vulgaris: randomized controlled trial. Lancet 2003; 362: 1347– 1 Rivera AE. Acne scarring: a review and current treatment modalities. J Am Acad Dermatol 2008; 59: 659–676.
12 Ruiz-Esparza J, Gomez JB. Non-ablasive radiofrequency 2 Thiboutot D, Gollnick H, Bettoli V, et al. New insights for active acne vulgaris: the use of deep dermal heat in into the management of acne: an update from the Global the treatment of moderate to severe active acne vulgaris Alliance to Improve Outcomes in Acne Group. J Am (thermotherapy): a report of 22 patients. Dermatol Surg Acad Dermatol 2009; 60(Suppl.): 1–50.
3 Kobayashi T, Tamada S. Selective electrothermolysis of 13 Ortiz A, Van Vliet M, Lask G, et al. A review of lasers the sebaceous glands: treatment of facial seborrhea.
and light sources in the treatment of acne vulgaris.
J Cosmet Laser Ther 2005; 7: 69–75.
4 Lloyd JR, Mirkov M. Selective photothermolysis of the 14 Choi YS, Suh HS, Yoon MY, et al. Intense pulsed light sebaceous glands for acne treatment. Lasers Surg Med vs. pulsed-dye laser in the treatment of facial acne: a randomized split-face trial. J Eur Acad Dermatol 5 Thiboutot D, Zaenglein A, Weiss J, et al. An aqueous gel ﬁxed combination of clindamycin phosphate 1.2% and 15 Haedersdal M, Togsverd-Bo K, Wulf HC. Evidence-based benzoyl peroxide 2.5% for the once-daily treatment of review of lasers, light sources and photodynamic therapy moderate to severe acne vulgaris: assessment of efﬁcacy in the treatment of acne vulgaris. J Eur Acad Dermatol and safety in 2813 patients. J Am Acad Dermatol 2008; 16 Hörfelt C, Funk J, Frohm-Nilsson M, et al. Topical 6 Gollnick HP, Draelos Z, Glenn MJ, et al. Adapalene- methyl aminolaevulinate photodynamic therapy for benzoyl peroxide, a unique ﬁxed-dose combination treatment of facial acne vulgaris: results of a randomized, topical gel for the treatment of acne vulgaris: a controlled study. Br J Dermatol 2006; 155: 608–613.
transatlantic, randomized, double-blind, controlled study 17 Haedersdal M, Togsverd-Bo K, Wiegell SR, et al. Long- in 1670 patients. Br J Dermatol 2009; 161: 1180–1189.
pulsed dye laser versus long-pulsed dye laser-assisted 7 Rao GR, Ghosh S, Dhurat R, et al. Efﬁcacy, safety, and photodynamic therapy for acne vulgaris: a randomized tolerability of microsphere adapalene vs. conventional controlled trial. J Am Acad Dermatol 2008; 58: adapalene for acne vulgaris. Int J Dermatol 2009; 48: 18 Oh SH, Ryu DJ, Han EC, et al. A comparative study of 8 Ellis CN, Krach KJ. Uses and complications of topical 5-aminolevulinic acid incubation times in isotretinoin therapy. J Am Acad Dermatol 2001; 45: photodynamic therapy with intense pulsed light for the treatment of inﬂammatory acne. Dermatol Surg 2009; 9 Akman A, Durusoy C, Senturk M, et al. Treatment of acne with intermittent and conventional isotretinoin: a International Journal of Dermatology 2011 ª 2011 The International Society of Dermatology
PRODUCTION OF DRUG NANOPARTICLES OF CONTROLLABLE SIZE USING SUPERCRITICAL FLUID ANTISOLVENT TECHNIQUE WITH ENHANCED MASS TRANSFER Gupta R.B1, and Chattopadhyay P.*2 1-Auburn University, 2-Ferro Corporation. Ferro Corporation, 7500, E. Pleasant Valley Road, Independence, OH 44133. U.S.A. Email: email@example.com Fax: (216) 7506915 ABSTRACT The use of supercritical