Apparatus and method for assessing and treating cellulite
An orange peel, tissue technology, applied in biochemical equipment and methods, skin system evaluation, preparations for skin care, etc., can solve problems such as lack of patient-to-patient accuracy
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example 1-C
[0339] Example 1 - Efficacy and safety of CCH for the treatment of EFP
[0340] In a phase 2a clinical trial of CCH for the treatment of cellulite, applicants demonstrated three doses of CCH (Low (0.06mg), Medium (0.48mg) and High (0.84mg)) showed improvements in the appearance of cellulite by the researchers' test endpoints and according to the overall cosmetic Measured by patient scores on the Outcome Improvement Scale (GAIS). Both the mid-dose and high-dose groups showed statistically significant improvements in cellulite appearance (measured by GAIS score) with p-values < 0.05 compared to placebo for both endpoints. In the mid-to-high dose group, 68% of patients reported being "satisfied" or "very satisfied" with their treatment outcomes, compared with 34% of patients in the randomized placebo group. CCH was well tolerated in all dose groups, and most adverse events (AEs) were mild to moderate and mainly limited to the local injection area.
[0341] Applicants next...
example 2
[0403] Example 2 - Clinician-reported and patient-reported data using existing scales for measuring cellulite severity Comparison of reported cellulite severity scales
[0404] The Hexsel Cellulite Severity Scale (CSS) is an assessment tool currently used to measure the severity of cellulite. The Hexsel CSS rated each of the 5 domains of cellulite (number of apparent depressions, depression depth, morphological skin surface changes, skin laxity, laxity or sagging, and the Nürnberger and Müller classification) on a scale from "0" ( No change) to "3" (most severe).
[0405] In the phase 2 trial, the PR-PCSS was used to rate 4 anatomical quadrants of the buttocks and posterolateral thigh in adult women with edematous collagen fibrillar sclerosis (cellulite) at screening. Clinicians assessed and reported cellulite severity in the same 4 quadrants using CR-PCSS and HexselCSS. Those with moderate or severe cellulite (i.e., CR-PCSS score of 3 or 4, PR-PCSS score of 3 or 4, and ...
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