A Single-Arm Study of HTIC (Heterologous Type I Collagen) Intradermal Injections for the Medical Treatment of Dermal Defects Due to Scarring, Hypotonia, and Hypotrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Measurement of the global aesthetic change between Visit 0 (Screening and Baseline) and Visit 5 (7 days) after the last HTIC injection
研究概览
简要总结
This clinical trial aims to evaluate the efficacy of the experimental medical device HTIC, which contains Type I collagen of animal origin, in treating skin defects such as scars, loss of tone, and volume in certain areas of the face and body. HTIC is administered through an injection technique applied under the skin. The main research question is: "Is it possible to achieve clinical improvement of skin defects through the use of the experimental device HTIC?"
Additionally, the study has the following secondary objectives:
- To assess any discomfort experienced during administration;
- To evaluate the subject's level of satisfaction following the entire treatment;
- To assess the safety and tolerability of the experimental device HTIC. HTIC is a sterile powder composed solely of animal-derived collagen (heterologous bovine Type I collagen, allergen-free and compliant with current regulations), packaged in 10 ml glass vials. Each vial contains 100 mg of sterile bovine Type I collagen powder.
The trial will be conducted at a single site in Italy, specifically at the Federico II University Hospital. A total of 45 subjects will participate in the study.
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
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (age between 18-50 years).
- •Subjects in good health.
- •Subjects that presented skin atrophy from acne scarring, other injury, or photo-aging (from mild to moderate).
- •Subjects with a score at least 2 according to the Modified Fitzpatrick Wrinkle Scale (MFWS).
- •The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Ethics Committee (EC).
排除标准
- •Subjects will not be enrolled in the study if any of the exclusion criteria listed below are met:
- •Pregnant or breastfeeding.
- •Subjects that had undergone other medical invasive aesthetic treatments for the last 18 months before the enrolment.
- •Subjects with acne.
- •Subjects with seborrheic skin.
- •Subjects with normotonic, normoelastic, and normotrophic skin.
- •Subjects with autoimmune connective tissue disorders (connectivopathies).
- •Subjects with a tendency to develop hypertrophic or keloid scars.
- •Subjects undergoing immunosuppressive therapy.
- •Any cutaneous pathology of infectious, inflammatory, viral and vascular type affecting the treated area.
- •History of allergy or hypersensitivity to any component of the study devices.
- •Performing permanent filler in the past.
- •Use of any therapeutic agent for photoaging or skin rejuvenation within 15 days from the enrolment.
- •Wound healing disorders.
- •Participation in other clinical studies.
结局指标
主要结局
Measurement of the global aesthetic change between Visit 0 (Screening and Baseline) and Visit 5 (7 days) after the last HTIC injection
时间窗: Screening and Baseline visit (day 0) and Visit 5 ( 7 days after the last HTIC injection_Visit 4)
The aesthetic change will be assessed by the Investigator using a 5-point Global Aesthetic Improvement Scale (GAIS) by comparing the subject's photograph taken prior and after the treatment. (Scale values: from 1 to 5.) Lower scores indicate a better outcome (greater aesthetic improvement), while higher scores indicate a worse outcome (no improvement or worsening).
次要结局
- Self-assessment of the subject's satisfaction with the procedure using a Visual Analog Scale (VAS), ranging from 0 (very satisfied) to 10 (very dissatisfied), at Visit 5 compared to Visit 1(Visit 5 (7 days from the last HTIC injection) and Visit 1(≤7 days from Screening & baseline visit_day 0))
- Clinical skin assessment together with photographic evaluation at Visit 0 and Visit 5, using the 7-point Modified Fitzpatrick Wrinkle Scale (MFWS).(Screening and Baseline visit (day 0) and visit 5 (7 days after the last HTIC injection_V4))
- Self-assessment of pain by the subject during the injection treatment at Visits 1, 2, 3, and 4, using a Visual Analog Scale (VAS) after each treatment(At visit 1(≤7 days from Screening & Baseline visit_day 0), Visit 2 (7 days from V1), Visit 3(7 days from V2) and Visit 4 (7 days from V3))
- Collection and evaluation of the rate of related adverse events (AEs) occurring during the study.(at Screening & Baseline visit (day 0), Visit 1(≤7 days from V0), Visit 2 (7 days from V1), Visit 3 (7 days from V2), Visit 4 (7 days from V3) and Visit 5 (7 days from V4_the last HTIC injection))