The Suitability of Tience® for the Treatment of Acne Scars
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Postacne Scarring: A Qualitative Global Scarring Grading System (Goodman and Baron)
研究概览
简要总结
This is an open-label, single-center, split-face, pseudo-randomized clinical trial designed to evaluate the efficacy and safety of a human-derived, cell-free adipose tissue derivative (Tience® ), for treating moderate to severe acne scars. Participants will receive three treatment sessions over a three-month period: on Day 0, Day 30, and Day 90. Treatment will be administered via injections to acne-scarred areas on one side of the face. The untreated side will be treated after the follow-up period. Outcomes will be evaluated over a twelve-month period using investigator clinical assessments, patient self-evaluation and VISIA skin analysis system to monitor changes in scar severity and overall skin quality.
详细描述
Tience®, a human adipose tissue derivative, is intended to be used in the human body for its original purpose to supplement and replace local extracellular matrix deficiencies in soft tissue, including skin. Tience provides a temporary conductive environment into the injured area. This facilitates the ability of local cells to re-populate the damaged soft tissue and skin area, thereby enabling the deposition of extracellular matrix and repair of the tissue. Tience is authorized for treatment of wounds, scars and soft tissue defects.
The purpose of this study is to determine whether the product is suitable for the treatment of acne scars, and to collect safety data on the use of Tience® in this indication.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •healthy volunteers aged 18-40 years who have at least 3-year- old acne scars on their cheeks.
排除标准
- •pregnancy or nursing
- •cancer or ongoing cancer treatment
- •an active skin disease
- •Fitzpatric scale 4-6 skin type
- •a strong medication used for treating severe acne (e.g., Isotretinoin)
- •active acne or Herpes
- •antihistamine medication (if the medication can be paused for 7 days during study visits, participation is possible)
- •use of biological medications
- •tendency for excessive scar formation
- •tendency for urticaria (hives)
- •systemic medication affecting immunity
- •autoimmune disease
- •known disease affecting blood clotting (bleeding or thrombosis tendency) (e.g., von Willebrand disease)
- •are allergic to the product being studied or any of its ingredients
研究组 & 干预措施
Intradermal injections of Tience® cell-free allogeneic adipose tissue product
Split face, Intradermal injections of Tience® cell-free allogeneic adipose tissue product on one side of the face.
干预措施: Intradermal injections (Procedure)
结局指标
主要结局
Postacne Scarring: A Qualitative Global Scarring Grading System (Goodman and Baron)
时间窗: Participants are evaluated at four time points: Day 0 (prior to the first treatment), Day 30 (prior to the second treatment), Day 90 (prior to the third treatment), and Day 180 (final evaluation visit)
The researcher will grade the participants' acne scars before treatments, and at final evaluation visit using the Goodman and Baron qualitative and quantitative acne scar scales. For the Goodman and Baron quantitative scar scale, scars will be categorized according to morphology by recording the number of mild, moderate, severe, and hypertrophic lesions. A total score (range: 0-84), with higher scores indicating greater severity and number of scars. For the Goodman and Baron qualitative scar scale, scars will be classified into four categories: Grade 1= macular, Grade 2= mild, Grade 3= moderate, and Grade 4= severe.
Visia® Gen7 Skin Analysis System
时间窗: Before first treatment, Day 30 before second treatment, Day 90 before third treatment, and Day 180 evaluation visit.
A Visia Gen7 skin analysis will be performed on the study participants before each treatment and at final evaluation visit 180 days after first treatment.
Self assessment of study participants
时间窗: 180 days
Subjective self-assessment of acne scars by study participants before each treatment and at the final evaluation visit.
次要结局
- The adverse reactions and adverse events assessment questionnaire for the participants(Assessment will be conducted 7 days after each treatment.)
- Descriptive safety evaluation of the researcher including incidence rates of adverse events(180 days)
- The adverse reactions and events assessment questionnaire for the researcher(Day 0 the first treatment, Day 30 the second treatment, and Day 90 the third treatment.)