BACKGROUND:Nasolabial folds (NLFs) are common age-related facial lines, often treated with dermal fillers. Princess FILLER Lidocaine (PFL; now saypha filler Lidocaine) and Juvéderm Ultra XC (JUXC) are both hyaluronic acid-based fillers used for this purpose. OBJECTIVES:The aim of the authors of this study is to evaluate the effectiveness and safety of PFL in reducing NLF severity compared with JUXC using a split-face study design. METHODS:In this randomized, subject- and investigator-blinded multicenter study, patients with moderate-to-severe NLFs received PFL on one side of the face and JUXC on the other. Baseline NLF severity was assessed using the 5-point NLF-Severity Rating Scale (NLF-SRS). Follow-up assessments occurred at Weeks 12, 24, 36, and/or 48. The primary endpoint was the proportion of NLF-SRS responders at Week 24. Secondary endpoints included assessments by photographic reviewers and treating investigators, along with Global Aesthetic Improvement Scale (GAIS) ratings. Safety was monitored by adverse event reporting and patient diaries. FACE-Q questionnaires evaluated patient satisfaction. Repeat treatment was permitted at Week 36 or 48 if needed. RESULTS:At Week 24, PFL demonstrated noninferiority to JUXC (82.2% vs 81.9% responders; difference 0.37%, P < .0001). Secondary assessments confirmed this finding. Adverse events occurred in 24.4% of patients post PFL, with most being mild to moderate. Serious treatment-emergent adverse events were rare (1.1%). CONCLUSIONS:PFL is a noninferior alternative to JUXC for treating moderate-to-severe NLFs, with comparable efficacy, safety, and patient satisfaction. LEVEL OF EVIDENCE: 1 (THERAPEUTIC):For image description, please refer to the figure legend and surrounding text.
BACKGROUND:Lasers are commonly used to treat fine lines and wrinkles. While traditional 1550-nm resurfacing lasers can be limited by their delivery mechanism, a newer 1550-nm nonablative resurfacing laser was recently developed, which uses a novel conical beam delivery system for high-energy treatments. OBJECTIVE:To evaluate the utility of this novel 1550-nm nonablative resurfacing laser that uses Focal Point Technology to improve fine lines and wrinkles in Fitzpatrick Skin Types I-VI with high-energy delivery. METHODS:A retrospective, multicenter clinical data review evaluated this device for fine lines and wrinkles by Fitzpatrick Wrinkle and Elastosis Scale with 3 blinded physician reviewers and blinded photographic identification. RESULTS:Thirty-three subjects were treated. Mean age was 56.7 years, and 84.8% were women. Subjects had significant overall improvement in pooled Fitzpatrick Wrinkle and Elastosis Scale score (4.48 vs 3.36; p < .001). For blinded photographic evaluation, 2 of 3 reviewers were in agreement for correct identification of 81.8% of subjects. Treatments were well-tolerated, and there were no serious unanticipated adverse events. CONCLUSION:This new-generation 1550-nm nonablative resurfacing laser that uses Focal Point Technology with high-energy delivery is safe and effective in the treatment of fines lines and wrinkles in diverse Fitzpatrick skin types.
BACKGROUND:There is a lack of evidence-based consensus to assist clinicians in using photobiomodulation (PBM). OBJECTIVE:To create a consensus on the safe and effective use of PBM. METHODS:A systematic literature review of Embase and MEDLINE was conducted in June 2022 to identify publications reporting research on PBM. An international multidisciplinary panel was convened to draft recommendations informed by the systematic search; they were refined through 2 rounds of Delphi survey, 2 consensus meetings, and iterative review by all panelists until unanimous consensus was achieved. RESULTS:A multidisciplinary panel of experts (n = 21) was assembled based on publication history. The key findings that informed the consensus developed by the expert panel were as follows: PBM is a safe treatment modality for adult patients and red light PBM does not induce DNA damage. PBM is an effective treatment option for peripheral neuropathy, androgenic alopecia, wound ulcers due to multiple etiologies, decubitus ulcers, pain attributed to diabetic foot ulcers, and acute radiation dermatitis. CONCLUSION:The systematic literature search and structured Delphi consensus approach culminated in an evidence-based clinical practice guideline for safe and effective use of PBM in medical and aesthetic applications. Future research will further bolster our understanding of this evolving noninvasive technique.
INTRODUCTION:The mental health burden associated with vitiligo can significantly impact patients' quality-of-life. Although successful for repigmentation of stable vitiligo, adoption of surgical melanocyte transplantation remains limited due to time and skilled-expertise requirements. A cell harvesting device prepares autologous skin cell suspension (ASCS) at point of care, simplifying the process. OBJECTIVE:To confirm early and favorable repigmentation response and evaluate health-related quality-of-life changes following ASCS treatment of stable vitiligo. METHODS:In this large (N = 107), prospective, multicenter study, vitiligo lesions were laser-ablated and received ASCS treatment followed by at-home phototherapy. RESULTS:All Fitzpatrick skin types and major vitiligo subtypes were represented. Excellent repigmentation response (≥80%) was observed by week 4. By week-24, all lesions demonstrated improvement; 67% achieved >50% repigmentation, 42% achieved ≥80% repigmentation, and 8% achieved complete repigmentation. Vitiligo Noticeability Scale response was attained by 27.7% of lesions; 72.3% of patients reported treatment satisfaction. Significant improvement from baseline in Vitiligo Quality-of-Life Instrument (P < .05) was observed at week-24. LIMITATIONS:No control. CONCLUSIONS:The cell harvesting device provides a simplified, more accessible technique for melanocyte transplantation. ASCS is highly effective for repigmentation of stable vitiligo lesions, with positive patient-reported outcomes and improvement in quality-of-life, as demonstrated in this large, diverse population.
