Moises Amselem, Dolly Fatsea, Riccardo Forte, Carlo Hasenöhrl, Ariel Haus, Ali Salaabian
{"title":"基于聚左旋乳酸的创新型注射用胶原蛋白刺激剂(Lanluma®)的安全性和有效性结果--上市后 9 个月的临床研究结果。","authors":"Moises Amselem, Dolly Fatsea, Riccardo Forte, Carlo Hasenöhrl, Ariel Haus, Ali Salaabian","doi":"10.1111/jocd.16527","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Injectable fillers for soft tissue augmentation stand out as one of the most favored procedures in the field of aesthetic medicine, especially in addressing the clinical signs of skin aging. Among soft tissue fillers, non-permanent fillers have been safely used in numerous medical applications for several decades.</p><p><strong>Aims: </strong>The aim of this post-market observational, open-label, uncontrolled, multicentered, prospective study (PMS) was to evaluate the effects of an injectable poly-L-lactic acid-based collagen stimulator (Lanluma®, the study product).</p><p><strong>Participants/methods: </strong>This analysis is based on the clinical outcomes data (safety and effectiveness) collected from investigators and participants between the first injection (T0, September 2022) and 9 months thereafter (T3, June 2023) in the treatment of five body-contouring areas.</p><p><strong>Results: </strong>Overall, 70 participants had 99 treatment sessions of the neck (31%), upper arm (20%), hand (17%), thigh (16%) and décolleté (15%). Lumps (neck, upper arm, hand) and nodules (neck, hand, thigh) were the most frequent adverse events (AEs) reported by investigators. All were treatment related. None were serious, severe or fatal. No AEs were reported following treatment of the décolleté. Both investigators and participants reported high levels of satisfaction during the nine-month follow-up period with the treatments in five body areas.</p><p><strong>Conclusions: </strong>These positive clinical outcomes can be attributed to a proper implementation of best practices and recommendations, and the rheological properties of the study product. This 9-month follow-up analysis should be reconsidered in light of the study's objectives for the final analysis at the 25-month follow-up.</p>","PeriodicalId":15546,"journal":{"name":"Journal of Cosmetic Dermatology","volume":null,"pages":null},"PeriodicalIF":2.3000,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and effectiveness results of an innovative injectable poly-L-lactic acid-based collagen stimulator (Lanluma®)-Clinical outcomes at 9 months in a post-market study.\",\"authors\":\"Moises Amselem, Dolly Fatsea, Riccardo Forte, Carlo Hasenöhrl, Ariel Haus, Ali Salaabian\",\"doi\":\"10.1111/jocd.16527\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Injectable fillers for soft tissue augmentation stand out as one of the most favored procedures in the field of aesthetic medicine, especially in addressing the clinical signs of skin aging. Among soft tissue fillers, non-permanent fillers have been safely used in numerous medical applications for several decades.</p><p><strong>Aims: </strong>The aim of this post-market observational, open-label, uncontrolled, multicentered, prospective study (PMS) was to evaluate the effects of an injectable poly-L-lactic acid-based collagen stimulator (Lanluma®, the study product).</p><p><strong>Participants/methods: </strong>This analysis is based on the clinical outcomes data (safety and effectiveness) collected from investigators and participants between the first injection (T0, September 2022) and 9 months thereafter (T3, June 2023) in the treatment of five body-contouring areas.</p><p><strong>Results: </strong>Overall, 70 participants had 99 treatment sessions of the neck (31%), upper arm (20%), hand (17%), thigh (16%) and décolleté (15%). Lumps (neck, upper arm, hand) and nodules (neck, hand, thigh) were the most frequent adverse events (AEs) reported by investigators. All were treatment related. None were serious, severe or fatal. No AEs were reported following treatment of the décolleté. Both investigators and participants reported high levels of satisfaction during the nine-month follow-up period with the treatments in five body areas.</p><p><strong>Conclusions: </strong>These positive clinical outcomes can be attributed to a proper implementation of best practices and recommendations, and the rheological properties of the study product. This 9-month follow-up analysis should be reconsidered in light of the study's objectives for the final analysis at the 25-month follow-up.</p>\",\"PeriodicalId\":15546,\"journal\":{\"name\":\"Journal of Cosmetic Dermatology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-09-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Cosmetic Dermatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/jocd.16527\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cosmetic Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/jocd.16527","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Safety and effectiveness results of an innovative injectable poly-L-lactic acid-based collagen stimulator (Lanluma®)-Clinical outcomes at 9 months in a post-market study.
Background: Injectable fillers for soft tissue augmentation stand out as one of the most favored procedures in the field of aesthetic medicine, especially in addressing the clinical signs of skin aging. Among soft tissue fillers, non-permanent fillers have been safely used in numerous medical applications for several decades.
Aims: The aim of this post-market observational, open-label, uncontrolled, multicentered, prospective study (PMS) was to evaluate the effects of an injectable poly-L-lactic acid-based collagen stimulator (Lanluma®, the study product).
Participants/methods: This analysis is based on the clinical outcomes data (safety and effectiveness) collected from investigators and participants between the first injection (T0, September 2022) and 9 months thereafter (T3, June 2023) in the treatment of five body-contouring areas.
Results: Overall, 70 participants had 99 treatment sessions of the neck (31%), upper arm (20%), hand (17%), thigh (16%) and décolleté (15%). Lumps (neck, upper arm, hand) and nodules (neck, hand, thigh) were the most frequent adverse events (AEs) reported by investigators. All were treatment related. None were serious, severe or fatal. No AEs were reported following treatment of the décolleté. Both investigators and participants reported high levels of satisfaction during the nine-month follow-up period with the treatments in five body areas.
Conclusions: These positive clinical outcomes can be attributed to a proper implementation of best practices and recommendations, and the rheological properties of the study product. This 9-month follow-up analysis should be reconsidered in light of the study's objectives for the final analysis at the 25-month follow-up.
期刊介绍:
The Journal of Cosmetic Dermatology publishes high quality, peer-reviewed articles on all aspects of cosmetic dermatology with the aim to foster the highest standards of patient care in cosmetic dermatology. Published quarterly, the Journal of Cosmetic Dermatology facilitates continuing professional development and provides a forum for the exchange of scientific research and innovative techniques.
The scope of coverage includes, but will not be limited to: healthy skin; skin maintenance; ageing skin; photodamage and photoprotection; rejuvenation; biochemistry, endocrinology and neuroimmunology of healthy skin; imaging; skin measurement; quality of life; skin types; sensitive skin; rosacea and acne; sebum; sweat; fat; phlebology; hair conservation, restoration and removal; nails and nail surgery; pigment; psychological and medicolegal issues; retinoids; cosmetic chemistry; dermopharmacy; cosmeceuticals; toiletries; striae; cellulite; cosmetic dermatological surgery; blepharoplasty; liposuction; surgical complications; botulinum; fillers, peels and dermabrasion; local and tumescent anaesthesia; electrosurgery; lasers, including laser physics, laser research and safety, vascular lasers, pigment lasers, hair removal lasers, tattoo removal lasers, resurfacing lasers, dermal remodelling lasers and laser complications.