Assessment of the Safety and Efficacy of the DensiStim Medical Device, an Injectable Liposomal Gel, in Adult Participants
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in facial skin thickness
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of intradermal injections of the medical device - hyaluronic acid with the addition of lecithin - in a population of participants with thin, dry, and sagging facial skin.
详细描述
A total of 36 participants are planned to be enrolled in the study (18 in each group: Group 1 - product administration using a needle; Group 2 - product administration using a cannula).
The primary endpoint will be the change in facial skin thickness resulting from three administrations of the DensiStim product, assessed no later than 8 weeks after the last procedure, based on ultrasound (US) measurements. Ultrasound measurements will also be compared between visits and between study arms.
Changes in aesthetic improvement will be assessed by both the participant and the Investigator. The safety of the investigational medical device will also be evaluated.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex;
- •Age over 18 years;
- •Caucasian race;
- •Thin, dry, and sagging facial skin;
- •Signing an informed consent form;
- •Commitment to refrain from undergoing facial therapies that may affect skin condition;
- •Negative pregnancy test result and commitment to use a contraceptve method;
排除标准
- •Scars, birthmarks, or tattoos on the face that could interfere with the assessment of skin condition;
- •Presence of open wounds, ulcers, active infections, or other significant skin damage at the planned injection site;
- •Receipt of intradermal facial injections with native hyaluronic acid, platelet-rich plasma, or other injectable therapies within 6 months prior to study initiation;
- •Receipt of intradermal facial injections with slowly absorbable or non-absorbable filler products within 12 months prior to study initiation;
- •Known hypersensitivity to any component of the investigational product;
- •Dermatitis or dermatological disease of inflammatory and/or infectious nature at the planned injection site;
- •History of cancer, autoimmune disease, or immunodeficiency;
- •Use of medications affecting blood coagulation;
- •Use of topical antihistamines, corticosteroids, or retinoids on the face within 4 weeks prior to the study;
- •Pregnancy or breastfeeding;
- •Participation or planned participation in other clinical trials;
结局指标
主要结局
Change in facial skin thickness
时间窗: No later than 8 weeks after the last injection
Change from baseline in facial skin thickness following three intradermal administrations of the DensiStim product, based on ultrasound measurements.
次要结局
- Change in facial skin thickness based on ultrasound measurements, comparison between visits(baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment)
- Change in facial skin thickness based on ultrasound measurements, comparison between study arms(baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment)
- Change in facial skin parameters based on multispectral skin analysis(baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment)
- Change in aesthetic improvement and psychological well-being scores, assessed by participants(baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment)
- Change in aesthetic improvement scores, assessed by the Investigator(baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment)
- Percentage of participants satisfied with the results of the injections(1 months and 2 months post-treatment)
- Post-injection sensation scores, assessed by participants using the Numeric Rating Scale Questionnaire(after first injection, after second injection, after third injection)
- Incidence of adverse events by event type(From enrollment to 2 months after the last injection)
- Percentage of participants who discontinued treatment due to adverse events(From enrollment to 2 months after the last injection)