The dermal filler Princess VOLUME is a highly cross-linked, viscoelastic hyaluronic acid injectable gel implant used for aesthetic treatment. To evaluate the efficacy and safety of Princess VOLUME in the treatment of nasolabial folds, an open-label uncontrolled, multicenter study was conducted. Forty-eight subjects were recruited who had moderate to deep wrinkles, according to the Modified Fitzpatrick Wrinkle Scale (MFWS). Subjects received Princess VOLUME in both nasolabial folds at Day 0. Nasolabial fold severity was evaluated at 30, 90, 180, and 270 days after treatment, using the MFWS and the Global Aesthetic Improvement Scale (GAIS). Adverse events and treatment site reactions were recorded. Among the 48 subjects, 93.8% were female with a median age of 52 years. There were significant improvements (P < 0.0001) in the MFWS scores at 30, 180, and 270 days after treatment compared with those at baseline, with a mean decrease of 1.484 (±0.408), 1.309 (±0.373), and 1.223 (±0.401), respectively; hence the primary endpoint was achieved and clinical efficacy demonstrated. Princess VOLUME was well tolerated, and most adverse events were injection site reactions of mild to moderate severity. Subject satisfaction (97.9%), subject recommendation of the treatment (93.6%), and investigators GAIS scores (97.9% improvement) were high.
BACKGROUND The demand for noninvasive skin-tightening body procedures is increasing. OBJECTIVE To develop a set of grading scales for the objective assessment of skin laxity and assess their reliability and validity. MATERIALS AND METHODS Two photonumeric grading scales were created and validated for skin laxity in female patients: Skin Laxity—Posterior Thighs/Buttocks, and Anterior Thighs/Knees. Fifteen aesthetic experts rated photographs of 50 women in 2 validation sessions. Responses were analyzed to assess inter-rater and intra-rater reliability. RESULTS Overall inter-rater reliability according to intraclass correlation efficient (ICC) 2.1 and weighted kappa was at least “substantial” for both scales in both sessions, and “almost perfect” (≥0.81) for the Anterior Thighs and Knees scale in session 2. Intra-rater reliability was “almost perfect” for both scales (ICC 2.1) and “substantial” to “almost perfect” by weighted kappa. A correlation between the skin laxity scales and body mass index, age, weight, sun exposure, and cellulite severity was observed. CONCLUSION The skin laxity photonumeric grading scales are valid and reliable instruments for assessing laxity on the posterior thighs and buttocks, and anterior thighs and knees. The scales will be of value for standardizing clinical evaluations and quantifying outcome measurements in research and clinical practice.
BACKGROUND New treatment methods for cellulite require globally accepted scales for aesthetic research and patient evaluation. OBJECTIVE To develop a set of grading scales for objective assessment of cellulite dimples on female buttocks and thighs and assess their reliability and validity. MATERIALS AND METHODS Two photonumeric grading scales were created and validated for dimples in the buttocks in female patients: Cellulite Dimples—At Rest, and Cellulite Dimples—Dynamic. Sixteen aesthetic experts rated photographs of 50 women in 2 validation sessions. Responses were analyzed to assess inter-rater and intra-rater reliability. RESULTS Overall inter-rater reliability and intra-rater reliability were both “almost perfect” (≥0.81, intraclass correlation efficient and weighted kappa) for the At Rest scale. For the Dynamic scale, inter-rater reliability and intra-rater reliability were “substantial” (0.61–0.80). There was a high correlation between the cellulite scales and body mass index, age, weight, and skin laxity assessments. CONCLUSION Consistent outcomes between raters and by individual raters at 2 time points confirm the reliability of the cellulite dimple grading scales for buttocks and thighs in female patients and suggest they will be a valuable tool for use in research and clinical practice.
In food occupations, like in many other skin risk occupations, the regular use of personal protection equipment, i.e. of skin protection ointments and protective gloves, is recommended as well as regular skin care for the prevention of occupational hand dermatitis. We investigated the uptake and maintenance of different prevention strategies (instructions for skin protection and skin care, prevocational skin hardening with UV light) in food occupations and their efficacy in the primary prevention of vocationally caused hand dermatitis. We could show that the acceptance and regular use of skin protection and care measures could be significantly increased by theoretical and practical instructions in food industry trainees. The highest acceptance was seen with skin protection ointment (100%) and skin care (90%). Protective gloves (43.3%) were used to a lesser extent. The hand dermatitis point prevalence in the groups after 6 months was 13.3% (skin protection), 19.4% (UV hardening) and 29.1% (controls). These clinical trends were supported by statistically significant differences in the basal TEWL values. Adequate skin protection and regular skin care seem to be promising for the prevention of occupationally caused hand dermatitis. The experimental approach using UV hardening prevocationally did not fulfil the expectations.
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