New Regenerative and Anti-aging Medicine Approach Based on Single Strand Alpha-1 Collagen for Neo-collagenesis Induction: Clinical and Instrumental Experience of a New Medical Device for Dermal Regeneration (Karisma)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- "Change from Baseline to day 60 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
研究概览
简要总结
Purpose/Objectives of the Study: Regenerative medicine, as well as aesthetic plastic surgery and dermatology field persistently seeks innovative, minimally invasive interventions to enhance skin quality and mitigate signs of aging. This study evaluates the regenerative capabilities of a new medical device focused on dermal redensification, induced by injections of single-strand alpha 1 collagen, to verify its ability, in a specific formulation (contained within a matrix of hyaluronic acid and carboxymethylcellulose), to induce dermal stimulation in both scar outcomes and regenerative medicine applied to skin aging.
详细描述
Study Population (including any inclusion/exclusion criteria): : A total of 100 patients, aged between 25 and 70 years of both sexes, subdivided into 3 demographically similar subgroups, will be assessed in this exploratory study. The intervention entailed the administration of the single-strand alpha 1 collagen - hyaluronic acid soft filler, with subsequent evaluations employing the Antera 3D® skin scanner and two multiple choice questionnaires, FACE-Q and Global Aesthetic Improvement Scale (GAIS) to obtain objective data and subjective evaluations recorded by patients. All patients must be in good general health. not affected by oncological, rheumatological, chronic inflammatory diseases (including dermatitis, psoriasis, etc.). patients should not take systemic drugs during the course of the aforementioned study. The sample size of 100 patients is in line with studies already carried out in this field, in order to obtain adequate statistical power, also in anticipation of a physiological drop out of some patients. Parametric and non-parametric tests will be used to test the results to assess the significance of discrete and continuous numerical variables, as well as descriptive statistics for all patient groups.
Within the scope of this project, the investigators plan to recruit four cohorts of subjects:
- smokers (30 subjects)
- non-smokers (30 subjects)
- subjects affected by acne scars (40)
All patients must be in general good health, not affected by oncological, rheumatological, allergic, chronic inflammatory diseases (including dermatitis, psoriasis, etc.). Patients should not have metabolic or cardiovascular diseases, should not have received other injections of hyaluronic acid or similar substances for at least 6 months before the start of treatment, and should not take systemic drugs during the study.
The primary endpoints will be those to evaluate the subjective changes in texture, hydration, compactness, brightness, and quality of skin roughness through the administration of multiple-choice tests already validated by numerous scientific studies (Global Aesthetic Improvement Scale GAIS; FACE-Q Age Appearance Appraisal) and objective changes through non-invasive measurements, such as dermal thickness by high-frequency ultrasound; the depth of wrinkles, amount of melanin and hemoglobin through 3D Antera Scanner, to assess the regenerative capabilities of the medical device in patients affected by acne scars, in the atrophic and dystrophic skin alterations of the body, as well as in the photo and chronoaging of the skin of the face, neck, and décolleté in smoking and non-smoking patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
single-group study cannot blind the occurred intervention: No masking
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range 20-65 years old
- •skin ageing evidences from mild to severe
- •Inclusion Criteria:
- •not affected by oncological diseases
- •rheumatological diseases
- •no allergic diseases
- •no chronic inflammatory diseases (including dermatitis, psoriasis, etc.). Patients should not have;
- •metabolic diseases
- •cardiovascular diseases,
- •should not have received other injections of hyaluronic acid or similar substances for at least 6 months before the start of treatment,
- •should not take systemic drugs during the study
排除标准
- 未提供
研究组 & 干预措施
Karisma arm
Selected participant (inclusion criteria) undergo one injection of single-strand alpha 1 collagen (3ml)
干预措施: Karisma (Other)
结局指标
主要结局
"Change from Baseline to day 60 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
时间窗: baseline and day 60
changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar; Melanin values are expressed in arbitrary values ranging from 0.1 to 1
"Change from Baseline in the Mean values of FACE-Q questionnaire at 15 days"
时间窗: baseline and day 15
FACE-Q questionnaire is a validated multiple choices questionnaire used to assess patient aging appraisaland perceived skin quality of face and neck. Test will be provided to patients at baseline and after 15 days in order to evaluate if any perceived changes are present. 47 questions will be provided. Every question has a 4 values answer ranging from 1 (I.E. very dissatisfied) to 4 (I.E. very satisfied).
"Change from Baseline to day 60 in hemoglobin quantity.
时间窗: baseline and day 60
changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure hemoglobin values that are expressed in arbitrary values ranging from 0.1 to 4
"Change from Baseline in the Mean values of FACE-Q questionnaire, at 30 days"
时间窗: baseline and day 30
FACE-Q questionnaire is a validated multiple choices questionnaire used to assess patient aging appraisaland perceived skin quality of face and neck. Test will be provided to patients at baseline and after 15 days in order to evaluate if any perceived changes are present. 47 questions will be provided. Every question has a 4 values answer ranging from 1 (I.E. very dissatisfied) to 4 (I.E. very satisfied).
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 30 days"
时间窗: baseline and day 30
The GAIS Global Aesthetic Improvement Scale, is a validated five-point scale for assessing global aesthetic improvement in appearence compared to pretratment. The ratings range from "very much improved", "much improved" "improved", unchanged and worsened.
"Change from Baseline to day 15 in the mean depth of skin wrinkles (mm)
时间窗: baseline and day 15
changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar, in a portion of skin selected by the investigator. skin depth is expressed in millimeters.
"Change from Baseline to day 30 in the mean depth of skin wrinkles (mm)
时间窗: baseline and day 30
changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar, in a portion of skin selected by the investigator. skin depth is expressed in millimeters.
"Change from Baseline to day 15 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
时间窗: baseline and day 15
changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar; Melanin values are expressed in arbitrary values ranging from 0.1 to 1
"Change from Baseline to day 15 in hemoglobin quantity.
时间窗: baseline and day 15
changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure hemoglobin values that are expressed in arbitrary values ranging from 0.1 to 4
"Change from Baseline to day 60 in the mean depth of skin wrinkles (mm)
时间窗: baseline and day 60
changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar, in a portion of skin selected by the investigator. skin depth is expressed in millimeters.
"Change from Baseline to day 30 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
时间窗: baseline and day 30
changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar; Melanin values are expressed in arbitrary values ranging from 0.1 to 1
"Change from Baseline to day 30 in hemoglobin quantity.
时间窗: baseline and day 30
changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure hemoglobin values that are expressed in arbitrary values ranging from 0.1 to 4
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 60 days"
时间窗: baseline and day 60
The GAIS Global Aesthetic Improvement Scale, is a validated five-point scale for assessing global aesthetic improvement in appearence compared to pretratment. The ratings range from "very much improved", "much improved" "improved", unchanged and worsened.
"Change from Baseline in the Mean values of FACE-Q questionnaire, at 60 days"
时间窗: baseline and day 60
FACE-Q questionnaire is a validated multiple choices questionnaire used to assess patient aging appraisaland perceived skin quality of face and neck. Test will be provided to patients at baseline and after 15 days in order to evaluate if any perceived changes are present. 47 questions will be provided. Every question has a 4 values answer ranging from 1 (I.E. very dissatisfied) to 4 (I.E. very satisfied).
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 15 days"
时间窗: baseline and day 15
The GAIS Global Aesthetic Improvement Scale, is a validated five-point scale for assessing global aesthetic improvement in appearence compared to pretratment. The ratings range from "very much improved", "much improved" "improved", unchanged and worsened.
次要结局
- tissue Biopsies(baseline and day 60)
研究者
Sonya Vasto
Associate professor
University of Palermo