The Influence of Different Treatment Combinations on Skin Laxity and Dimpling.

OBJECTIVE: The aim of the study was to identify the effectiveness of the combination of tissue stabilized guided subcision, microfocused ultrasound, and minimally invasive calcium hydroxylapatite injections in various sequences for treating skin surface irregularities of the buttocks and thighs. MATERIAL AND METHODS: 61 females (body mass index: 22.6 ± 2.4 kg/m², age: 37.2 ± 6.8 years) were enrolled in this randomized interventional prospective study. Treatment arms included a variable combination and sequence of three treatment modalities: (1) Tissue-stabilized guided subcision, (2) microfocused ultrasound, and (3) calcium hydroxylapatite injections. Six months after the final intervention skin laxity and skin dimpling severity scores were assessed by the study participants, the treating physicians and by eleven blinded independent board-certified experts. RESULTS: No adverse events were observed during the study that required intervention outside the standard of care treatment protocol. The combination of three treatment modalities was shown to provide greater improvement in skin laxity 1.88 (95% CI, 0.66–5.37) and skin dimpling 1.31 (95% CI, 0.61–2.81) scores as compared to any combination of two modalities. The combination of concomitant microfocused ultrasound and calcium hydroxylapatite injections followed three months later by tissue stabilized guided subcision yielded the greatest improvement in skin laxity 2.23 (95% CI, 0.51–9.82) and skin dimpling 1.79 (95% CI, 0.67–4.78) at 9-month follow-up. CONCLUSION: This study provides evidence for the effectiveness of combination therapies for the improvement of skin surface irregularities on the buttocks and thighs. J Drugs Dermatol. 2020;19(11): 1030-1038. doi:10.36849/JDD.2020.5117.

Validated Assessment Scales for Cellulite Dimples on the Buttocks and Thighs in Female Patients.

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.

Validated Assessment Scales for Skin Laxity on the Posterior Thighs, Buttocks, Anterior Thighs, and Knees in Female Patients.

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.

An open-label uncontrolled, multicenter study for the evaluation of the efficacy and safety of the dermal filler Princess VOLUME in the treatment of nasolabial folds.

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.