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© 2009 The Authors JEADV 2009, 23 , 523–528 Journal compilation © 2009 European Academy of Dermatology and Venereology DOI: 10.1111/j.1468-3083.2009.03101.x JEADV Blackwell Publishing Ltd ORIGINAL ARTICLE A validated photonumeric cellulite severity scale DM Hexsel, † T Dal’Forno, ‡ * CL Hexsel § † School of Medicine, University of Passo Fundo, Passo Fundo, Brazil ‡ Federal University of Rio Grande do Sul, Rio Grande do Sul, Brazil § Department of Dermatology, Henry Ford Hospital, Detroit, MI, USA *Correspondence: D Hexsel. E-mail: dohexsel@terra.com.br Abstract Background With recent advances in the treatment of cellulite and localized fat, a comprehensive objective method of measuring cellulite can be potentially useful, especially since important morphological aspects of cellulite are not part of the current classification. Objective To develop and to validate a new photonumeric cellulite severity. Methods Based on standardized photographs of 55 patients with cellulite, five key morphological aspects of cellulite were identified. A new photonumeric severity scale was developed and validated. Results The five key morphological features of cellulite were identified and included the number of depressions, depth of depressions, clinical appearance of evident raised lesions, and presence of flaccidity and the grade of cellulite. Each item was graded from 0 to 3, allowing final classification of cellulite as mild, moderate, and severe. Results for validation of the scale are statistically significant ( P < 0.05) and are as follows: intraclass correlation coefficient > 0.7; correlation item-total > 0.7, with the exception of the right buttock; intraclass correlation coefficients 0.881–0.922; Cronbach’s alpha 0.851–0.989 and factor analysis 68–76%. Conclusion The proposed photonumeric scale is a consistent, comprehensive, reliable, and reproducible tool for the standardized and objective assessment of the severity of cellulite. Received: 28 February 2008; Accepted 10 September 2008 Keywords classification, cellulite, localized fat, morphological aspects, scale, severity Conflicts of interest The authors hereby affirm that neither the manuscript nor any part of it has been published or is being considered for publication elsewhere . Introduction While the current classification of cellulite, illustrated in Table 1, describes different grades of cellulite, which is very important, there are additional key morphological aspects that affect the severity of cellulite and therefore can be influenced by treatment options. For this reason, the authors created and validated a new method to measure and classify the severity of cellulite, which compliments the current classification by suggesting the assessment of additional important clinical and morphological aspects. Cellulite is characterized by relief alterations of the skin surface, which give the skin an orange peel, 1,2 cottage cheese, 3 or mattress appearance 1 in addition to other morphological variants. The relief alterations of cellulite include depressions and raised areas. The depressions are caused by retraction of the skin by subcuta- neous fibrous septa, while raised areas are projections of fat and subcutaneous structures to the skin surface. 1,4,5 Flaccidity, laxity, or sagging of the skin further aggravates relief alterations in the majority of patients. Cellulite usually presents after puberty and tends to be chronic. While it is a common clinical condition affecting the majority of women of all countries and cultures, it is rarely found in men. It mainly affects the buttocks and thighs, although other areas of the body such as the abdomen, arms, and back may also be affected. 1,2 Because of its cosmetically unattractive appearance and its fre- quency, patients often desire treatment options and prevention Previous presentations: Presented as an exhibit poster at 65th American Academy of Dermatology (2–6 February 2007, Washington, DC), podium oral presentations at the 16th EADV Congress (16–20 May 2007, Vienna, Austria) and at the II International Symposium of Cellulite (30–31 May 2008, Rio de Janeiro, Brazil). 524 Hexsel et al. © 2009 The Authors JEADV 2009, 23 , 523–528 Journal compilation © 2009 European Academy of Dermatology and Venereology measures. Therefore, appropriate research to investigate treat- ment options is warranted. With recent advances in surgical and medical treatments, such as Subcision®, liposuction, 6 non-invasive laser lypolisis, 7 radiofre- quency, and the increasing marketing of topical or mechanical treatments for cellulite, research is needed and a comprehensive objective method of measuring cellulite can be potentially very useful. With the purpose of creating an objective method to measure cellulite severity and the effects of different treatment modalities, a new cellulite severity scale (CSS) and classification was devel- oped. Validation was carried out in order to test its efficacy and reproducibility in the diagnosis and classification of the condi- tion. The proposed scale expands the current classification by adding four items, therefore allowing a comprehensive measure- ment of the intensity of the condition. It is an objective method that can facilitate patient follow-up and measure treatment outcomes. Objective To develop and validate a photonumeric scale for grading severity of cellulite, called the Hexsel, Dal’Forno & Hexsel Cellulite Severity Scale (CSS) and a new classification system for cellulite. Materials and methods A photonumeric scale that grades the severity of cellulite was developed based on extensive clinical and photographic evaluations of baseline pictures from a sample of 55 patients that participated in two cellulite clinical trials. These trials were approved by local Ethic Committee and were performed in conformance to the ethical guidelines of the 1975 Declaration of Helsinki. Informed consent for participation and release of photographs for scientific purposes was obtained from all participants. To be included, patients had to be healthy female individuals, 18–45 years of age (mean 33.8 ± 7.58), body mass index between 18.5 and 29.9 (mean 25 ± 3.01) with a clinical diagnosis of cellulite with grades I to III according to the classification that ranges from 0 to III 8 (Table 1), located on the thighs and/or buttocks. The photographs were taken in a standardized manner: in the same room by the same investigator, with the same camera fixed at the same location. All patients stood at the same distance from the camera, in the standing position with relaxed gluteus muscles, as illustrated in Fig. 1. A one-piece black body suit was used as standard clothing by all patients. Five key clinical morphologic features of cellulite were identified: (A) the number of evident depressions; (B) depth of depressions; (C) morphological appearance of skin surface alterations; (D) grade of laxity, flaccidity or sagging skin; and (E) the classification scale originally described by Nürnberger and Müller 8 (Fig. 1). After extensive analysis of the photographs of all the 55 patients, the photonumeric scale was constructed based on the most representative pictures of the sample of 55 patients. The final photonumeric scale consists of 20 pictures, which were derived from 18 of these 55 patients. The severity of each item was graded from 0 to 3, allowing a final sum of scores that range numerically from 1 to 15. Based on the final numeric score, cellulite was further classified as mild, moderate, or severe. Since cellulite mainly affects the buttocks and thighs, other areas of the body such as the abdomen, arms, and back that are less frequentlyaffected were not included in the validation of the scale. After the development of the photonumeric scale, the scale was validated. Validation of the scale As determined a priori by the statistician, for a significance level of P < 0.05, one of the authors of the scale, Dr T. Dal’Forno as the ‘gold standard’ or the ‘evaluator author’, applied the scale thrice to all the photographs of the sample of 55 patients. These was once during the study and twice again during the validation process with one week interval. As determined a priori by the statistician, for a significance level of P < 0.05, independent evaluation of the set of standardized photographs of the aforementioned 55 patients, was also obtained from two dermatologists that were unfamiliar with the scale. A copy of the CSS (Fig. 1) was provided to all three dermatologist evaluators. The two independent evaluators and the evaluator author applied the CSS to each photograph of each of the following areas: left buttock (LB), right buttock (RB), left posterior thigh (LT), and right posterior thigh (RT). Statistical analysis As determined a priori, statistical analysis for validation included four tests: intraclass correlation coefficient, item-total correlation, Cronbach’s alpha, and factor analysis. Table 1 Current classification of cellulite, based on the data from medical literature Grade or stage Clinical characteristics 0 (zero) There is no alteration of the skin surface. I The skin of the affected area is smooth while the subject is standing or lying, but the alterations to the skin surface can be seen by pinching the skin or with muscle contraction. II The orange skin or mattress appearance is evident when standing, without the use of any manipulation (skin pinching or muscle contraction). III The alterations described in grade or stage II, are present together with raised areas and nodules. Photonumeric cellulite severity scale 525 © 2009 The Authors JEADV 2009, 23 , 523–528 Journal compilation © 2009 European Academy of Dermatology and Venereology The intraclass correlation coefficient evaluates the level of concordance between the evaluators and for the same evaluator at different time points; to determine whether the evaluation is consistent. Ideally, the scale should allow consistent grading of the severity of cellulite independently of the evaluator and the time of the evaluation. The correlation item total assesses whether all items of the scale are necessary (in this case, a through e) and whether there are any superfluous components of a scale that do not contribute to the final goal of the scale or intended diagnosis. The Cronbach’s alpha evaluates the internal consistency of a scale to ensure that there is no item in which multiple results are possible when there is diverse opinion between evaluators. F actor analysis assesses whether the scale effectively measures a single factor or the same condition (in this case, cellulite). Generally, a mini- mum of 60% of variance is necessary for satisfactory accomplishment. Figure 1 Hexsel Dal’Forno & Hexsel CSS. 526 Hexsel et al. © 2009 The Authors JEADV 2009, 23 , 523–528 Journal compilation © 2009 European Academy of Dermatology and Venereology Results The most important results regarding the development and validation of the Photonumeric CSS are described below: Photonumeric cellulite severity scale (A) Number of evident depressions This item refers to the total number of evident depressions by visual inspection in the area to be examined. The scores are expressed as folloes: ZERO = None/no depressions 1 = A small amount: 1–4 depressions are visible 2 = A moderate amount: 5–9 depressions are visible 3 = A large amount: 10 or more depressions are visible (B) Depth of depressions This item evaluates the depth of depressions by visual inspection of the affected areas; comparison to the pictures of CSS is recommended. ZERO = No depressions 1 = Superficial depressions 2 = Medium depth depressions 3 = Deep depressions (C) MORPHOLOGICAL APPEARANCE OF SKIN SURFACE ALTERATIONS Item C assesses the different morphological patterns of skin surface alterations; comparison with the pictures of CSS is recommended. ZERO = No raised areas 1 = ‘Orange peel’ appearance 2 = ‘Cottage cheese’ appearance 3 = ‘Mattress’ appearance (D) GRADE OF LAXITY, FLACCIDITY OR SAGGING SKIN Laxity, flaccidity, or sagging skin confers the affected skin a draped appearance. 1 This effect aggravates the appearance of cellulite. Item D assesses the grade of flaccidity and comparison to the pictures of CSS is recommended. ZERO = Absence of laxity, flaccidity, or sagging skin 1 = Slight draped appearance 2 = Moderate draped appearance 3 = Severe draped appearance (E) CLASSIFICATION SCALE BY NÜRNBERGER AND MÜLLER This item is based on the current classification of cellulite 1,5,6,8 shown in the Table 1. Patients should be evaluated in the standing position with relaxed gluteus muscles. However, if the patient has no evident depressions, they should be asked to contract their glu- teus muscles or the pinch test should be applied (by pinching the skin between the thumb and index finger) in order to differentiate between scores 0 and 1 1,5,6 (see Fig. 1, item E – contracted). ZERO = Zero grade 1 = First grade 2 = Second grade 3 = Third grade The new classification of cellulite as mild, moderate, and severe is determined by the severity scores obtained for sections A to E, as illustrated in Table 2: Validation and statistical analysis of the new scale The intraclass correlation coefficient analysis resulted in values over 0.7 for all studied regions, as illustrated in the Table 3. Correlation values very close to 1 are ideal and considered strong if above 0.7. All correlations were statistically significant ( P < 0.001). 9 The intraclass correlation coefficient analysis of the results of the evaluator author at three different time points also demonstrated the consistency of the scale, in the LB ( r = 0.921; P < 0.001), RB ( r = 0.881; P < 0.001), LT ( r = 0.922; P < 0.001) and RT ( r = 0.889; P < 0.001). All items (number of depressions, depth of depressions, morphology of skin surface alterations, presence of flaccidity and grade of cellulite) had Cronbach’s alpha values varying from 0.851 to 0.989, according to the region (Table 4). The correlation item total showed that all items were necessary in order to grade the severity of cellulite (> 0.7), with the exception of flaccidity in the RB, in which the coefficient was 0.563 (Table 4). The factor analysis values encountered were 68% for the LB, 67% for the RB, 76% for the LT and 74% for the RT. Discussion The results of the validation pertain to cellulite of the thighs and buttocks. When compared to the results of the evaluator author, the factor analysis demonstrated that the scale effectively measured a single factor or the same condition, in this case, cellulite. Generally, a minimum of 60% of variance is necessary for satisfactory accomplishment. 10 Strong correlation item total values were found. Although flaccidity, laxity, or sagging skin of the RB had a smaller correla- tion item total than the remainder of the items (LB, RT, LT), the authors kept flaccidity in the classification and scale since the lower values were only on the right side and most importantly, because flaccidity may require additional physical examination and it is a considerable aggravating factor that seems to contribute Table 2 Scoring system of the cellulite severity scale and cellulite new classification Cellulite severity scale New classification 1–5 Mild 6–10 Moderate 11–15 Severe Table 3 Analysis of the concordance between the investigators Region Intraclass correlation coefficientP-value LB 0.938 < 0.001 RB 0.934 < 0.001 LT 0.922 < 0.001 RT 0.939 < 0.001 Photonumeric cellulite severity scale 527 © 2009 The Authors JEADV 2009, 23 , 523–528 Journal compilation © 2009 European Academy of Dermatology and Venereology at least partially to surface alterations in the affected areas, and as evidence in (Fig. 2a,b). 5 Laxity, flaccidity, and sagging skin are caused by physiological ptosis of subcutaneous structures, making the skin permanently distended and sagg. 1 Flaccidity is more frequently observed on the inner parts of the buttocks, thighs, and arms, in the region above the knees and around the buttocks and proximal thigh as well as in the abdomen and lower back. It is important to highlight that most of cellulite lesions are oval in shape with the longest axis lying parallel to the relaxed skin tension lines, 5 which is likely related to flaccidity. Flaccidity is aggravated by aging and the force of gravity and is related to personal characteristics of the skin in some patients. Flaccidity is often seen worsening cellulite in patients over 30 years of age. By the current classification system reported by Nürnberger and Müller in 1978 8 (Table 1), different clinical aspects or different severity of cellulite may be attributed to the same grade. The new photonumeric cellulite severity scale allows the qualitative and quantitative assessment of four additional key clinical and morphological aspects that significantly affect the severity of cellulite and therefore can potentially be influenced by treatment options. From the clinical experience of thousands of patients and some clinical trials, the present authors consider very important to objectively evaluate these additional morphological aspects, not only in the assessment of cellulite but also in its treatment responses. The head to head comparison between the two classifications is illustrated in Fig. 3(a–c). Conclusion This article introduces a validated photonumeric severity scale of cellulite, which objectively adds additional morphologic characteristics of cellulite to the current classification. By summing the scores of the five items, the new CSS facilitates the objective classification of cellulite as mild, moderate, or severe. The new photonumeric CSS and the resulting classification system may be useful in the assessment of different therapeutic modalities for treating cellulite. Both the scale and the new classification can be applied in a standardized manner. Table 4 Results of item-total correlation analysis and Cronbach’s alpha values LB RB LT RT Item-total Correlation (A) Number of evident depressed lesions 0.893 0.880 0.899 0.907 (B) Depth of depressed lesions 0.734 0.753 0.783 0.746 (C) Morphological appereance of laxity, flacidity or sagging skin 0.869 0.909 0.872 0.885 (D) Grade of laxity, flaccidity or sagging skin 0.737 0.563 0.897 0.858 (E) Classification scale by nürnberger and müller 0.876 0.922 0.905 0.894 Cronbach’s alpha 0.869 0.851 0.913 0.989 (P < 0.01) (P < 0.01) (P < 0.01) (P < 0.01) Figure 2 (a) A pinch test applied to the LT making cellulite more evident. (b) Distention test is made by distending the skin against gravity, improving cellulite in areas of laxity. 528 Hexsel et al. © 2009 The Authors JEADV 2009, 23 , 523–528 Journal compilation © 2009 European Academy of Dermatology and Venereology Data analysis demonstrated that the CSS is a consistent, com- prehensive, reliable, and reproducible tool for the complete assessment of cellulite severity and can therefore be successfully used by dermatologists as a valuable instrument for research and clinical evaluation of patients with cellulite. Funding/support This study was supported by the Brazilian Center for Studies in Dermatology, a non-profit organization that promotes research in Dermatology. Acknowledgements The authors are grateful to the dermatologists Josiane Burmann Viecili, MD, and Cristine Kloekner Kraemer, MD, for their participation in the validation process, to the Clinical Coordina- tors of the Brazilian Center for Studies in Dermatology, Debora Zechmeister do Prado, Pharmacist, and Maryelle Lima Gamboa, Pharmacist, for their assistance in the elaboration of this article and figures and to the Statistician Mathias Bressel, BS, Federal University of Rio Grande do Sul for his expertise. References 1 Hexsel DM. Body repair. In: Parish LC, Brenner S, Ramos-e-Silva M, eds. Women’s Dermatology – from Infancy to Maturity . Parthenon Publishing, New York (NY), 2001: 586–595. 2 Rossi AB, Vergnanini AL. Cellulite: a review. J Eur Acad Dermatol Venerol 2000; 14 : 251–262. 3 Draelos ZD, Marenus KD. Cellulite. Etiology and purported treatment. Dermatol Surg 1997; 23 : 1177–1181. 4 Hexsel DM, Gobbato DO, Mazzuco R, Hexsel CL. Subcision ® . In: Kede MPV, Sabatovitch O, eds. Dermatologia Estética . Ateneu, São Paulo (SP), 2003: 350–359. 5 Hexsel D. Dal’Forno TO, Cignachi S. Definition, clinical aspects, associated conditions, and differential diagnosis. In: Goldman MP, Bacci PA, Leibaschoff G, Hexsel D, Angelini F, eds. Cellulite – Pathophysiology and Treatment . Taylor&Francis, New York (NY), 2006: 7–28. 6 Hexsel DM, Mazzuco R. Subcision: a treatment for cellulite. Int J Dermatol 2000; 39 : 539–544. 7 Alster TS, Tehrani M. Treatment of cellulite with optical devices: an overview with practical considerations. Lasers Surg Med 2006; 38 : 727–730. 8 Nürnberger F, Müller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol 1978; 4 : 221–229. 9 Hripcsak G, Heitjan DF. Measuring agreement in medical informatics reliability studies. J Biomed Inform 2002; 35 : 99–110. 10 Hair JF, Anderson RE, Tatham RL, Black WC, eds. Multivariate Data Analysis . Prentice Hall, Upper Saddle River (NJ), 1998. Figure 3 (a–c) Head to head comparison between the two classifications: current classification vs. the new Cellulite Severity Scale and Classification. << /ASCII85EncodePages false /AllowTransparency false /AutoPositionEPSFiles true /AutoRotatePages /None /Binding /Left /CalGrayProfile (Dot Gain 20%) /CalRGBProfile (sRGB IEC61966-2.1) /CalCMYKProfile (U.S. Web Coated \050SWOP\051 v2) /sRGBProfile (sRGB IEC61966-2.1) /CannotEmbedFontPolicy /Warning /CompatibilityLevel 1.4 /CompressObjects /Tags /CompressPages true /ConvertImagesToIndexed true /PassThroughJPEGImages true /CreateJDFFile false /CreateJobTicket false /DefaultRenderingIntent /Default /DetectBlends true /DetectCurves 0.1000 /ColorConversionStrategy /sRGB /DoThumbnails false /EmbedAllFonts true /EmbedOpenType false /ParseICCProfilesInComments true /EmbedJobOptions true /DSCReportingLevel 0 /EmitDSCWarnings false /EndPage -1 /ImageMemory 1048576 /LockDistillerParams false /MaxSubsetPct 35 /Optimize true /OPM 1 /ParseDSCComments 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