A two‐center, assessor‐blinded, prospective trial evaluating the efficacy of a novel hypertonic draining cream for cellulite reduction: A Clinical and instrumental (Antera 3D CS) assessment

摘要

Summary Introduction Gynoid lipodystrophy, also known as cellulite, is a very common skin alteration representing mainly a cosmetic problem rather than a real disease. An effective treatment of cellulite has not been well established. The initial phase of cellulite is characterized by subdermal tissue edema with interstitial fluids retention. A new hypertonic topical product with draining action ( HTC ) containing NaCl 13%, escine, caffeine, and beta‐sitosterol has been recently developed. A 28‐day double‐blind placebo‐controlled study has shown that this cream is able to reduce thigh circumference and the thickness of adipose tissue. No data so far are available regarding an objective evaluation of skin appearance for a longer application period. Study aim To evaluate the clinical efficacy of 2‐month HCT treatment with clinical and instrumental assessments. Subjects and methods In a prospective, 2‐center, assessor‐blinded trial 20 women (mean age 34 years) with cellulite of Grade I‐III in severity were enrolled after their informed consent. HTC was applied once daily for 60 days. Primary outcomes of the trial were the evolution of thigh circumference measurements (assessed at baseline, after 1 and 2 months) and the computer‐analysis of skin profilometry (ie, skin volumes) of a prespecified target area evaluated by means of Antera 3D CS digitalized images (assessed at baseline and at the end of the trial). Secondary outcome was the orange peel severity score (from 0 to 5) before and after pitch test. Results All subjects concluded the study period. Thigh circumference was reduced by ?0.88 (right)/?1.2 cm (left) and by ?1.8(right)/?2.1 (left) cm, after 30 and 60 days of treatment, respectively ( P = .001, Wilcoxon test vs baseline). Antera 3D profilometry of the target zone showed a significant reduction in skin depression expressed in mm 3 of ?56% (from 59.7 to 26.73 mm 3 ) after HTC application. Orange peel (no pitch test) mean ( SD ) score was 2.3 (1) at baseline, 2.0 (1) and 1.8 (0.8) after 1 and 2 months ( P = .0031), respectively. After‐pitch orange peel score was significantly reduced after treatment (from 3.3 to 2.2). Conclusion Once daily application of HTC for 2 months has confirmed its efficacy in the improvement of objective and subjective assessments of cellulite parameters.( Trial Number registration : ISRCTN 15111614).