Multicenter, Double Blind, Randomized, Controlled Clinical Investigation to Evaluate the Performance of Autocross-linked Hyaluronic Acid for the Treatment of Hypertrophic Scars
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 4
- 主要终点
- Change from baseline to Day 90 in POSAS total score for Observer
研究概览
简要总结
The study includes two study groups, one involves treatment with auto-cross-linked Hyaluronic acid by intralesional and hypodermic injection, repeated after two weeks (T14), while the control arm provides an equal treatment but with isotonic saline solution.
Enrolled patients will be randomized into 2 groups with an allocation of 2:1 in study treatment arm and control arm respectively. They will be evaluated using the POSAS scale before the treatment and re-evaluated at 30, 90 and 180 days after treatment.
The scar evaluation will be completed by an ultrasound assessment at time 0 (T0), 30 (T30), T90 and T180 and the DLQI (Dermatology Life Quality Index) to be assessed at time 0 (T0), 30 (T30), 90 (T90) and 180 (T180).
In subjects that will consent, a small surgical biopsy for an explorative evaluation of the scar tissue will be performed before (T0) and after treatment (T30) for a histological assessment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Male or female subjects aged ≥ 18 and ≤ 85 years
- •Subjects with hypertrophic scars caused by trauma, burn or iatrogenic injury with or without involvement of the mobile joints
- •Scar > 2 to < 25 cm2 of surface
- •Scar not previously treated with corticosteroids, laser or other invasive treatments
- •Scar present for at least 12 months
- •Scar located in all areas of the body with the exception of the face and neck
- •Fitzpatrick skin score of I-VI
- •Subjects willing to comply with all the steps of treatment and follow-up visits
- •Subjects willing to refrain from any cosmetic intervention in the area to be treated during the clinical investigation
- •Female of child-bearing potential (i.e. not in menopausal status from at least one year or permanently sterilized) must have a negative urine pregnancy test prior the first treatment
排除标准
- •Subjects with type I and type II diabetes mellitus
- •Subjects with oncological diseases in progress or in remission
- •Subjects receiving immunosuppressive drugs and corticosteroids, anticoagulants, antiplatelet agents
- •Subjects with autoimmune diseases including connectivitis
- •Subjects with congenital or acquired immunodeficiencies (including metabolic ones)
- •Subjects with known allergy or hypersensitivity to hyaluronic acid or its derivatives
- •Participation in clinical trials/investigations in the last 30 days
- •Pregnant or breastfeeding women
- •If female and of child-bearing potential, subject not using a highly effective method of birth control and not willing to use it during the participation to the clinical investigation
- •Subjects not willing to avoid tanning during the clinical investigation
- •Subjects with inflammations of the skin, including rosacea
- •Subject with skin infection in the area to be treated
- •Subjects having a high probability of non-compliance with the study procedures according to Investigator's judgement
结局指标
主要结局
Change from baseline to Day 90 in POSAS total score for Observer
时间窗: 90 days after treatment
The performance of two injections of IAL-SYSTEM ACP in improving the quality of the scar after 90 days from the first treatment in patients with hypertrophic scars will be evaluated by the mean change from baseline to Day 90 in POSAS total score for Observer.
次要结局
- To evaluate the performance of IAL-SYSTEM ACP in improving the quality of the scar(after 30 and 180 days from the first treatment)
- To assess the changing in the Quality of life after 30, 90 and 180 days from the first treatment with the Dermatology Life Quality Index (DLQI)(after 30, 90 and 180 days from the first treatment)
- To assess the changing in the dermal volume after 30, 90 and 180 days from the first treatment(after 30, 90 and 180 days)
- Safety of the treatment. Number of patients with treatment related adverse events(throug clinical investigation completion, an average one year)