Comparisons of Clinician-Reported and Patient-Reported Cellulite Severity Scales With Existing Scales for Measurement of Cellulite Severity
Vernon L. Young, MD1, Neil Sadick2, Genzhou Liu, PhD3, Neil Shusterman, MD3, Michael McLane, PhD3, David Hurley, MD3, Mitchel Goldman, MD4.
1Mercy Health Research - Washington, Washington, MO, USA, 2Weill Medical College of Cornell University, New York, NY, USA, 3Endo Pharmaceuticals Inc., Malvern, PA, USA, 4Goldman, Butterwick, Groff, Fabi and Wu Cosmetic Laser Dermatology, San Diego, CA, USA.
BACKGROUND: Edematous fibrosclerotic panniculopathy (cellulite) is a common condition in women. The Hexsel Cellulite Severity Scale (CSS) is a current evaluation tool to measure cellulite severity. The Hexsel CSS rates each of 5 domains of cellulite (number of evident depressions, depression depth, morphologic skin surface alterations, skin laxity, flaccidity, or sagging, and Nürnberger and Müller classification) from "0" (no alteration) to "3" (most severe). Two new cellulite assessment tools, the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS), have been developed to facilitate robust assessment of cellulite severity. These two 5-point photonumeric scales rate cellulite severity from "0" (none) to "4" (severe) from a patient's (PR-PCSS) and clinician's (CR-PCSS) perspective.
METHODS: In a phase 2 trial, adult women with edematous fibrosclerotic panniculopathy (cellulite) rated 4 anatomical quadrants of the buttocks and posterolateral thighs at screening using the PR-PCSS. Clinicians assessed the same 4 quadrants and reported cellulite severity using the CR-PCSS and the Hexsel CSS. Patients who had ≥1 quadrant with moderate or severe cellulite (ie, CR-PCSS score of 3 or 4, PR-PCSS score of 3 or 4, and Hexsel CSS score ≤13) at screening and Day 1 were randomly assigned to receive a pharmacologic treatment or placebo in 1 cellulite quadrant. The CR-PCSS, PR-PCSS, and Hexsel CSS were completed at screening and at Days 1, 22, 43, and 71. The Subject Global Aesthetic Improvement Scale (S-GAIS), which assesses patient-rated improvement in cellulite from 3 ("very much improved") to -3 ("very much worse"), was completed at Day 71. Agreements between CR-PCSS and Hexsel CSS, between CR-PCSS and PR-PCSS, and between mean changes in PR-PCSS from Day 1 to Day 71 and S-GAIS score at Day 71 were evaluated using Spearman rank correlation.
RESULTS: A total of 375 patients were randomized to treatment and received ≥1 treatment sessions (intent-to-treat population [ITT]). Ratings on the CR-PCSS, PR-PCSS, and Hexsel CSS at screening (N=1500) were included in correlation calculations. CR-PCSS scores significantly correlated with Hexsel CSS total scores overall (P<0.001) and in the thighs (P<0.001) and buttocks (P<0.001). Significant correlations between clinician and patient rating scales (CR-PCSS and PR-PCSS) were also observed overall (P<0.001) and within each target area (P<0.001 for both). In patients in the modified ITT population (patients in the ITT with ≥1 post-injection CR-PCSS and PR-CSS assessment, n=352), mean changes in PR-PCSS score correlated with ratings of aesthetic change on the S-GAIS (P<0.001).
CONCLUSIONS: The CR-PCSS may be an easier way for physicians to evaluate cellulite (ie, single item) than the 5-domain Hexsel scale). Positive correlations between CR-PCSS and Hexsel CSS total scores and between PR-PCSS and S-GAIS support the validity of CR-PCSS and PR-PCSS in terms of standard scales (Hexsel CSS and S-GAIS). PR-PCSS correlated to the CR-PCSS (P<0.001), indicating that the 2 scales evaluated the disease state similarly (ie, static evaluations of cellulite severity).
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