A Single-Center Study Evaluating the Effects of a Novel Retinol and Cannabidiol Combination Topical on Facial Skin.

Background: While retinol is known to reduce the appearance of fine lines and wrinkles, it is associated with irritating effects. However, when combined with water soluble cannabidiol (CBD; CR Topical), CBD may act to reduce oxidative stress and inflammation, mitigating irritation from retinol and further improving the skin's appearance through independent anti-aging mechanisms. Objectives: To assess the efficacy and tolerability of CR-Topical for improving facial skin. Methods: In this prospective, single-center pilot study, 9 female patients and one male patient aged 20 to 53 years who presented with facial skin imperfections (visible pores, dehydration, roughness, and/or static/dynamic wrinkles) applied CR-Topical to the entire face once daily for 42 days. Outcomes were measured on days 1, 21, and 42 using the Global Ranking Scale (GRS) with Comprehensive Skin Analysis by the patient and senior investigator as well as by a blinded reviewer (board-certified plastic surgeon). Dynamic videos and static imagery were taken before and after treatment, and patient satisfaction surveys were completed. Results: Global improvement across all 13 domains was observed, with the greatest mean differences for visible pores (2.0; 95% CI, 1.5-2.5), dehydration (2.0; 95% CI, 1.4-2.6), surface roughness (1.8; 95% CI, 1.2-2.4), static wrinkles (1.8; 95% CI, 1.1-2.5), and dynamic wrinkles (1.6; 95% CI, 0.8-2.3). Patient satisfaction (100%) and willingness to recommend the product to others (90%) were high, and tolerability of CR-Topical was excellent. Conclusions: CR-Topical is effective at improving global skin quality, including static and dynamic wrinkles. This study also used 4-dimensional analysis in the evaluation, a novel and developing method.

Validating a Series of Photonumeric Rating Scales for Use in Facial Aesthetics Using Statistical Analysis of Intra- and Inter-rater Reliability.

Background: Growing demand for minimally invasive aesthetic procedures to correct age-related facial changes and optimize facial proportions has been met with innovation but has created an unmet need for objective assessment tools to evaluate results empirically. Objectives: The purpose of this study is to establish the intra- and inter-rater reliability of ordinal, photonumeric, 4-, or 5-point rating scales for clinical use to assess facial aesthetics. Methods: Board-certified plastic surgeons and dermatologists (3 raters) performed live validation of jawline contour, temple volume, chin retrusion, nasolabial folds, vertical perioral lip lines, midface volume loss, lip fullness, and crow's feet dynamic- and at rest-rating scales over 2 rounds, 2 weeks apart. Subjects selected for live validation represented the range of scores and included 54 to 83 subjects for each scale. Test-retest reliability was quantitated through intra- and inter-rater reliability, determined from the mean weighted kappa and round 2 intraclass correlation coefficients, respectively. The clinical significance of a 1-grade difference was assessed through rater comparison of 31 pairs of side-by-side photographs of subjects with the same grade or a different grade on the developed scales. Results: The study demonstrated substantial to near-perfect intra- and inter-rater reliability of all scales when utilized by trained raters to assess a diverse group of live subjects. Furthermore, the clinical significance of a 1-point difference on all the developed scales was established. Conclusions: The high test-retest reliability and intuitive layout of these scales provide an objective approach with standardized ratings for clinical assessment of various facial features.

A 12-Month Study to Evaluate Safety and Efficacy of Polymethylmethacrylate-Collagen Gel for Correction of Midface Volume Loss Using a Blunt Cannula as Measured by 3-D Imaging.

BACKGROUND: Although polymethylmethacrylate (PMMA)-collagen gel is approved for correction of nasolabial folds, there are no reports characterizing safety and efficacy in the midface, an area where fillers are often used in clinical practice. OBJECTIVE: To determine the safety and efficacy of PMMA-collagen gel for long-term volume restoration in the midface. METHODS: In this prospective, single-center, 12-month study, 23 subjects with a pretreatment Midface Volume Deficit Scale (MFVDS) grade of 3, 4, or 5 were treated with PMMA-collagen gel. Efficacy was measured by the investigator and blinded reviewers using the MFVDS at 3, 6, and 12 months. Subject Global Aesthetic Improvement Scale (SGAIS) and physician GAIS (PGAIS) ratings were collected at 3, 6, and 12 months. RESULTS: Improvement in the MFVDS score from baseline was significant at all post-treatment time points (p < .0001). All subjects with baseline MFVDS grades of 5 (severe) or 4 (significant) had a grade of 0 (none) or 1 (minimal) at 12 months. Subject GAIS (SGAIS) and PGAIS ratings of improved or much improved were 100% at Month 3 and were maintained at 12 months (PGAIS = 100%, SGAIS = 91.3%). All adverse events were minor. CONCLUSION: Polymethylmethacrylate-collagen gel is safe and effective for long-lasting correction of midface volume deficit.

Nonsurgical Tissue Repositioning: Analysis of Long-Term Results and Patient Satisfaction From 100 Absorbable Suture Suspension Cases.

BACKGROUND: Absorbable suspension sutures are the only nonsurgical modality approved for tissue repositioning. OBJECTIVES: To quantitate patient perceptions of treatment at 24 months and determine the impact of age and prior surgical procedures on perceptions of efficacy, treatment longevity, and overall satisfaction. In addition, the authors sought to describe the impact of treatment with absorbable suspension sutures on the likelihood a patient will undergo future surgical procedures. METHODS: The first 100 treated patients who underwent treatment with absorbable suspension sutures, by the senior author, were critically evaluated. Subjects completed surveys 24 months following initial treatment. RESULTS: Of the initial 100 patients, complete records were available for 80 patients (age 39-86). Eighteen (22.5%) received a second treatment with absorbable suspension sutures and average time to second treatment was 23.4 months (range 13-37 months). Overall satisfaction was affected by age, 100% of patients ≤ 50 vs. 60% of patients > 50 (P = 0.026). Prior surgery appeared to be a factor in patient perception of efficacy: 82.6% of patients with no prior surgery indicated that absorbable suspension sutures were effective vs. 45.5% of patients with a prior surgical procedure (P = 0.0286). Just under one third of pretreatment surgical patients underwent surgery following treatment while 25% of surgery naïve patients went on to have surgery. Importantly, satisfaction with the initial procedure does not preclude later surgery. CONCLUSIONS: Treatment with absorbable suspension sutures is associated with high satisfaction through 24 months and does deter patients from surgery. The combination of lift and volumization results in 4-dimensional rejuvenation that includes rejuvenation of dynamic expression.

Postmarket Experience of Polymethylmethacrylate-Collagen Gel Dermal Filler.

BACKGROUND: This report synthesizes 12 years of postmarket surveillance data (PMSD) for polymethylmethacrylate (PMMA)-collagen gel dermal filler. OBJECTIVE: To present PMMA-collagen gel PMSD findings on real-world safety. METHODS: Postmarket surveillance data were collected from January 2007 to December 2018 and evaluated to determine the overall adverse event (AE) complaint rate, the nature of reported AEs, and whether the complaint included on-label, off-label, both, or unknown areas. RESULTS: In the 12 years examined, 754,229 PMMA-collagen gel syringes were distributed worldwide, and 839 product-related complaints (including those classified as unknown) resulted in an overall complaint rate of 0.11%. The 3 most frequent primary complaints in AE reports were lump/bump (309/839, 37%), nodule (152/839, 18%), and swelling (138/839, 16%). Histologically confirmed granuloma accounted for 17/839 complaints (2.0%; overall complaint rate of 0.002%), and histologically unconfirmed granuloma accounted for 66/839 complaints (8%; overall rate of 0.009%). There were 666 complaints representing AEs related to off-label injection in which the periocular area was most frequently represented. CONCLUSION: Although a limiting factor across all PMSD is voluntary reporting and resultant underrepresentation of AEs, the PMSD reported here are consistent with safety findings from US clinical studies in more than 1,500 patients with up to 5 years of follow-up.