NCT06914583招募中不适用
A Prospective, Multi-center, Randomized, No-treatment Controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Safety and Effectiveness of Sodium Hyaluronate 32 mg/ml for Improvement of Facial Skin Dryness and Dullness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator
研究概览
简要总结
The aim of the study is to evaluate the safety and efficacy of sodium hyaluronate 32 mg/ml in improving facial skin dryness and dullness. Subjects are randomized to the treatment group or to the control group. Only subjects in the treatment group are treated by intradermal injection.
详细描述
This is a prospective multi-center clinical investigation. Enrolled subjects are randomized to the treatment group or to the no-treatment control group. The treatment group will receive intradermal injections of sodium hyaluronate 32 mg/ml. The improvement of facial skin dryness and dullness will be evaluated at multiple timepoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years old and ≤65 years old (based on the time of signing the ICF), gender is not restricted;
- •Skin Fitzpatrick is classified as type II-IV;
- •Subjects who are seeking temporary improvement of their dry facial skin and dull complexion. The investigator has assessed the subjects are suitable for receiving injectable treatment to improve these conditions;
- •Subjects who have agreed not to use any other medical cosmetic treatments related to the study during the study period;
- •Subjects who voluntarily sign a written informed consent form, and able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on investigator's judgement.
排除标准
- •Known allergy to hyaluronic acid or any component of this product;
- •Known history of severe allergies;
- •Known history of severe autoimmune disease;
- •Subjects with episode of herpes cutis;
- •Subjects with cicatricial diathesis;
- •Facial area has unknown injection substances;
- •Have received any permanent or semi-permanent fillers at the facial area (e.g., calcium hydroxyapatite, poly-L-lactic acid, polymethyl methacrylate, silicones, expanded polytetrafluoroethylene (ePTFE), polycaprolactone, etc.), autologous fat, face lift (including thread lifts), etc., or plan to receive any of the above treatments during the investigation;
- •Have received temporary dermal filler treatment (e.g., cross-linked hyaluronic acid, collagen) at the facial area within the 12 months prior to enrolment, or plan to receive any of the above treatments during the investigation;
- •Have received botulinum toxin injection, mesotherapy, or facial cosmetic procedures (e.g., facial liposuction, cosmetic surgery, face slimming, photo modulation therapy, intense pulsed light, radiofrequency, non-cross-linked hyaluronic acid injection (except for mesotherapy), dermabrasion, laser or chemical peels or other ablation procedures, etc.) at facial area within 6 months prior to enrolment, or plan to receive any of the above treatments during the investigation;
- •Have received sodium hyaluronate compound solution injection (mesotherapy, etc) at facial area within 3 months prior to enrolment,
- •Facial area has active or progressive skin infection (including viral, bacterial, fungal);
- •Facial area has skin granuloma;
- •Facial area has active or progressive skin diseases or with isomorphic reactions such as acute eczema, flat warts, lichen planus, psoriasis vulgaris, etc.;
- •Facial area has malignant tumors or skin tumors of unknown nature;
- •Subjects who work outdoors for a long time or need to be exposed to sunlight after surgery;
- •Patients with excessive expectations for treatment effects;
- •Subjects with coagulation dysfunction or other systemic diseases;
- •Subjects undergoing chemotherapy/radiotherapy;
- •Subjects with mental illness or emotional instability;
- •Subjects who had received any thrombolytic agents, anticoagulants or antiplatelet drugs within 2 weeks before enrolment;
- •Subjects who are pregnant or planned to become pregnant during the investigation period, or breastfeeding;
- •Subject who participated in other clinical investigation within 1 month prior to enrolment in this investigation, or currently participating in other clinical investigation;
- •The investigator considers that the subject is not suitable to participate in this clinical investigation.
结局指标
主要结局
GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator
时间窗: 12 week
Treatment effective rate (third-party blinded investigator assessment)
次要结局
- Serum alanine aminotransferase (ALT)(0week, 12week, 32 week)
- Subject treatment satisfaction assessment scale(4week, 8week, 10week, 12week, 16week, 20week)
- Red blood cell (RBC)(0week, 12week, 32 week)
- White blood cell (WBC)(0week, 12week, 32 week)
- Platelet count (PLT)(0week, 12week, 32 week)
- Hemoglobin (HGB)(0week, 12week, 32 week)
- Serum aspartate aminotransferase (AST)(0week, 12week, 32 week)
- Serum urea nitrogen/urea (BUN/Urea)(0week, 12week, 32 week)
- Serum creatinin (Cr)(0week, 12week, 32 week)
- Blood glucose (GLU)(0week, 12week, 32 week)
- Urine pH(0week, 12week, 32 week)
- Thrombin time (TT)(0week)
- Urine glucose(0week, 12week, 32 week)
- Urine protein(0week, 12week, 32 week)
- Urine specific gravity(0week, 12week, 32 week)
- Urine red blood cell count(0week, 12week, 32 week)
- Urine white blood cell count(0week, 12week, 32 week)
- Urine nitrite(0week, 12week, 32 week)
- Prothrombin time (PT)(0week)
- Activated partial thromboplastin time (APTT)(0week)
- Fibrinogen (FIB)(0week)
- Temperature (°C)(0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week)
- Blood pressure (mmHg)(0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week)
- Respiration rate(0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week)
- Heart rate(0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week)
- Incidence rate of adverse events (AEs)(0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week)
- Incidence rate of serious adverse events (SAEs)(0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week)
- Incidence rate of adverse device effects (ADE)(0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week)
- Incidence rate of serious adverse device effects (SADE)(0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week)
- Incidence rate of injection site reactions(1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week)
- Incidence rate of device deficiencies(0week, 4week, 8week)
- GAIS-Blinded evaluator(4week, 8week, 10week, 16week, 20week)
- GAIS-Investigator(4week, 8week, 10week, 12week, 16week, 20week)
- GAIS-Subject(4week, 8week, 10week, 12week, 16week, 20week)
- Improvement of skin moisture(4week, 8week, 10week, 12week, 16week, 20week)
- Skin dryness improvement assessment - Investigator(4week, 8week, 10week, 12week, 16week, 20week)
- Skin dryness improvement assessment - Subject(4week, 8week, 10week, 12week, 16week, 20week)
- Skin dullness improvement assessment - Investigator(4week, 8week, 10week, 12week, 16week, 20week)
- Skin dulless improvement - Subject(4week, 8week, 10week, 12week, 16week, 20week)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
3 期
Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye SyndromeDry Eye SyndromeNCT01382225Alcon Research1,936
撤回
不适用
Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)EpicondylitisTennis ElbowEpicondylosisNCT02861183Anika Therapeutics, Inc.
已完成
3 期
Treatment of pain and damage of the Joint of the Mandible by means of Injection of Hialuronato de Sódio MedicineTemporomandibular joint disorder syndromeC05.500.607.221.897.897RBR-6759yzniversidade Federal de Minas Gerais
已完成
3 期
Randomized trial analysing the efficacy of hyaluronic acid and normal saline in colonic endoscopic mucosal resectioColorectal tumorsJPRN-UMIN000005457Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine200
已完成
2 期
Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal DrynessThe Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal DrynessNCT01557179Lee's Pharmaceutical Limited144