Sile Shen, Siwei Qu, Mingdian Wang, Kai Ji, Yang Zhou, Jian Chen, Chengyuan Wang
{"title":"皮内注射用胶原填充剂的疗效和安全性：一项随机、前瞻性、多中心对照研究。","authors":"Sile Shen, Siwei Qu, Mingdian Wang, Kai Ji, Yang Zhou, Jian Chen, Chengyuan Wang","doi":"10.1007/s00266-025-04960-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>With the increasing demand for minimally invasive aesthetic procedures, intradermal injection has emerged as a promising method to improve skin condition. However, there is a lack of robust clinical evidence supporting the efficacy and safety of intradermal collagen injections.</p><p><strong>Objective: </strong>The purpose of this study is to investigate the improvement of facial skin and safety of collagen intradermal injections.</p><p><strong>Methods: </strong>This prospective, multicenter, randomized, assessor-masked clinical trial enrolled 480 subjects aged 18-65 seeking facial skin enhancement. Subjects were randomized into treatment (n = 240) and control (n = 240) groups. The treatment group received three sessions of intradermal collagen injections at four-week intervals. Assessments included the Global Aesthetic Improvement Scale (GAIS), composite scale for skin dryness and dull complexion, Allergan Fine Lines Scale (AFLS), Allergan Skin Roughness Scale (ASRS), skin hydration, elasticity, and safety evaluations.</p><p><strong>Results: </strong>The GAIS and skin improvement rates showed significant differences between groups (P < 0.0001), with the treatment group demonstrating superior efficacy. No significant differences were observed in skin hydration and elasticity (P > 0.05). The treatment group exhibited higher improvement rates in GAIS, dull complexion, fine lines, and skin roughness at 4 weeks post-final injection compared to the control group. No severe treatment-emergent adverse events related to the trial device occurred.</p><p><strong>Conclusion: </strong>Intradermal collagen injections significantly enhance skin texture and demonstrate safety and reliability in clinical settings, offering a favorable risk-benefit ratio for appropriate candidates.</p><p><strong>Level of evidence i: </strong>This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .</p>","PeriodicalId":7609,"journal":{"name":"Aesthetic Plastic Surgery","volume":" ","pages":""},"PeriodicalIF":2.0000,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Collagen Filler for Intradermal Injection: A Randomized Prospective Controlled Multicenter Study.\",\"authors\":\"Sile Shen, Siwei Qu, Mingdian Wang, Kai Ji, Yang Zhou, Jian Chen, Chengyuan Wang\",\"doi\":\"10.1007/s00266-025-04960-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>With the increasing demand for minimally invasive aesthetic procedures, intradermal injection has emerged as a promising method to improve skin condition. 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Assessments included the Global Aesthetic Improvement Scale (GAIS), composite scale for skin dryness and dull complexion, Allergan Fine Lines Scale (AFLS), Allergan Skin Roughness Scale (ASRS), skin hydration, elasticity, and safety evaluations.</p><p><strong>Results: </strong>The GAIS and skin improvement rates showed significant differences between groups (P < 0.0001), with the treatment group demonstrating superior efficacy. No significant differences were observed in skin hydration and elasticity (P > 0.05). The treatment group exhibited higher improvement rates in GAIS, dull complexion, fine lines, and skin roughness at 4 weeks post-final injection compared to the control group. No severe treatment-emergent adverse events related to the trial device occurred.</p><p><strong>Conclusion: </strong>Intradermal collagen injections significantly enhance skin texture and demonstrate safety and reliability in clinical settings, offering a favorable risk-benefit ratio for appropriate candidates.</p><p><strong>Level of evidence i: </strong>This journal requires that authors assign a level of evidence to each article. 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Efficacy and Safety of Collagen Filler for Intradermal Injection: A Randomized Prospective Controlled Multicenter Study.
Background: With the increasing demand for minimally invasive aesthetic procedures, intradermal injection has emerged as a promising method to improve skin condition. However, there is a lack of robust clinical evidence supporting the efficacy and safety of intradermal collagen injections.
Objective: The purpose of this study is to investigate the improvement of facial skin and safety of collagen intradermal injections.
Methods: This prospective, multicenter, randomized, assessor-masked clinical trial enrolled 480 subjects aged 18-65 seeking facial skin enhancement. Subjects were randomized into treatment (n = 240) and control (n = 240) groups. The treatment group received three sessions of intradermal collagen injections at four-week intervals. Assessments included the Global Aesthetic Improvement Scale (GAIS), composite scale for skin dryness and dull complexion, Allergan Fine Lines Scale (AFLS), Allergan Skin Roughness Scale (ASRS), skin hydration, elasticity, and safety evaluations.
Results: The GAIS and skin improvement rates showed significant differences between groups (P < 0.0001), with the treatment group demonstrating superior efficacy. No significant differences were observed in skin hydration and elasticity (P > 0.05). The treatment group exhibited higher improvement rates in GAIS, dull complexion, fine lines, and skin roughness at 4 weeks post-final injection compared to the control group. No severe treatment-emergent adverse events related to the trial device occurred.
Conclusion: Intradermal collagen injections significantly enhance skin texture and demonstrate safety and reliability in clinical settings, offering a favorable risk-benefit ratio for appropriate candidates.
Level of evidence i: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
期刊介绍：
Aesthetic Plastic Surgery is a publication of the International Society of Aesthetic Plastic Surgery and the official journal of the European Association of Societies of Aesthetic Plastic Surgery (EASAPS), Società Italiana di Chirurgia Plastica Ricostruttiva ed Estetica (SICPRE), Vereinigung der Deutschen Aesthetisch Plastischen Chirurgen (VDAPC), the Romanian Aesthetic Surgery Society (RASS), Asociación Española de Cirugía Estética Plástica (AECEP), La Sociedad Argentina de Cirugía Plástica, Estética y Reparadora (SACPER), the Rhinoplasty Society of Europe (RSE), the Iranian Society of Plastic and Aesthetic Surgeons (ISPAS), the Singapore Association of Plastic Surgeons (SAPS), the Australasian Society of Aesthetic Plastic Surgeons (ASAPS), the Egyptian Society of Plastic and Reconstructive Surgeons (ESPRS), and the Sociedad Chilena de Cirugía Plástica, Reconstructiva y Estética (SCCP).
Aesthetic Plastic Surgery provides a forum for original articles advancing the art of aesthetic plastic surgery. Many describe surgical craftsmanship; others deal with complications in surgical procedures and methods by which to treat or avoid them. Coverage includes "second thoughts" on established techniques, which might be abandoned, modified, or improved. Also included are case histories; improvements in surgical instruments, pharmaceuticals, and operating room equipment; and discussions of problems such as the role of psychosocial factors in the doctor-patient and the patient-public interrelationships.
Aesthetic Plastic Surgery is covered in Current Contents/Clinical Medicine, SciSearch, Research Alert, Index Medicus-Medline, and Excerpta Medica/Embase.
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