A Prospective, Multicenter, Randomized, No-Treatment-Controlled, Assessor-Blinded, Superiority Clinical Investigation to Evaluate the Safety and Effectiveness of Kytogen Defend in Facial Skin Quality Improvement

Sinclair Pharmaceuticals Limited0 个研究点目标入组 500 人开始时间: 2025年9月22日最近更新: 2025年9月17日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Sinclair Pharmaceuticals Limited
入组人数: 500
主要终点: The global aesthetic improvement scale and facial skin dryness and dull complexion comprehensively improvement

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study was designed to evaluate the efficacy and safety of KIO021, an injectable solution for carboxymethyl chitosan, for temporary improvement of facial skin condition. Designed for forward-looking effectiveness.

To achieve this, it is planned that 500 subjects with dry skin and dull complexion on the face will be included in the injection.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•(1) Subjects ≥18 years (subject to the time of signing the ICF), without any restriction on gender; (2) Skin types ranging from type II to IV according to Fitzpatrick classification; (3) The subject exhibits symptoms of dry skin and dull complexion on face, and has a temporary need to improve the quality of facial skin. After evaluation by the investigator, it is deemed suitable for improvement through the medical device used in this trial;

排除标准

•(1) Subjects who have known allergies to Carboxymethyl Chitosan Solutions or any ingredients contained in the product; have known allergies to any local anesthetics (e.g., lidocaine or other amide-type anesthetics) or to an excipient of 5% EMLA cream; are allergic to chlorhexidine (or similar products) or to an excipient found in 0.5% alcohol chlorhexidine; or have a history of severe allergies or any episodes of anaphylactic shock; (2) Subjects having participated in other clinical trials within 1 month prior to enrollment in this trial or being currently participating in other clinical trials; (3) Females who are pregnant, breastfeeding, or planning to become pregnant during the study, or those who have been menopausal for less than 1 year or are in the perimenopausal phase without undergoing hormone therapy; (4) Subjects who have been exposed to strong sunlight or strong ultraviolet rays within 1 month before screening, or who are expected to work outdoors for a long time or need to be exposed to strong sunlight or ultraviolet rays during the study period; (5) Having tattoos, piercings, significant facial hair, scars, deformities, unhealed wounds, active skin diseases or inflammation or infections (e.g., herpes, acne, eczema, dermatitis, psoriasis, herpes zoster, mycosis and papillomas, etc.), abscess, granuloma, active or persistent perinasal infection, cancers or precancerous lesions, malignant tumours or skin swellings with unknown nature, unknown injections, and facial subcutaneous fixations (mesh, thread, gold twisted wire), etc. in the injection and evaluation area that may affect the effectiveness evaluation or increase treatment-related risks; (6) Subjects who are considered not suitable for participating in this clinical trial according to evaluation of investigators.

结局指标

主要结局

The global aesthetic improvement scale and facial skin dryness and dull complexion comprehensively improvement

时间窗: From enrollment to the end of treatment at 3 months

次要结局

未报告次要终点

研究者

发起方

Sinclair Pharmaceuticals Limited

申办方类型

Industry

责任方

Sponsor

相似试验

终止

2 期

A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune DiseaseDry Eye Disease

NCT05629364Kiora Pharmaceuticals, Inc.4

已完成

2 期

A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial DefectsPersistent Corneal Epithelial Defect

NCT05436288Kiora Pharmaceuticals, Inc.10

尚未招募

2 期

Phase II Clinical Trial: Efficacy and Safety of Kaempferia Parviflora in Treatment of Chronic Vertigo PatientsDizzinessKaempferia parviflora&#44chronic vertigo&#44Dizziness Handicap Inventory&#44Vestibular function

TCTR20181122001Agricultural Research Development Agency (Public Organization)72

进行中（未招募）

不适用

Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling

NCT06872359Kiomed Pharma210

终止

3 期

A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)HTLV-1 Associated Myelopathy

NCT03191526Kyowa Kirin Co., Ltd.66