Autologous Fat Cells Transfer for the Treatment of Atrophic Post Acne Scars: Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- • Change in atrophic acne scars assessment
研究概览
简要总结
This single-center, clinical trial consists of a one autologous fat grafting treatment followed by1-week , 1month , 3-month and 6-month post-treatment visits in order to assess the efficacy and complications of fat grafting when used for facial atrophic acne scars on cheeks.
详细描述
This investigation, pilot study will evaluate the safety and efficacy of autologous fat grafting for the treatment of atrophic acne scarring on cheeks. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural on the Goodman-Barron scale.
The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at the end of the follow-up period.
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with atrophic post acne scars on the cheeks, between 20 - 40 years old
- •Not to apply other treatments a month before the procedure
- •Informed consent to enter the study
排除标准
- •First grade of Goodman - Barron scale.
- •A systemic or associated skin disease that may affect the results of the study
- •patients with chronic consumption of nonsteroidal anti-inflammatory drugs (NSAIDs) or other non-aggregating agents.
- •Patients with acne in the acute stage
- •Pregnancy and breastfeeding
- •Tendency to form keloids
结局指标
主要结局
• Change in atrophic acne scars assessment
时间窗: Baseline and 6 Months
Acne scars will be used to evaluate efficacy of treatment using the Goodman- Barron scale \[which is an acne scars severity scale divided into 4 grades * First grade consists of hyper-or hypopigmented flat marks * Second grade consists of mild atrophy or hypertrophy that may not be obvious at social distances of 50 cm or greater and may be covered adequately by makeup * Third grade consists of moderate atrophic or hypertrophic scarring that is obvious at social distances of 50 cm or greater and is not covered easily by makeup or the normal shadow * Fourth grade severe atrophic or hypertrophic scarring that is obvious at social distances of 50 cm or greater and is not covered easily by makeup or the normal shadow\]. The grade of acne scars from final visit will be compared to their baseline grade visually evaluated by the study team.
Change in patient satisfaction
时间窗: 3 Months, and 6 Months
The modified global aesthetic improvement scale for patient evaluation module which consists of 5 degrees * Exceptionally improved \[The ideal result has been achieve\] * much improved\[The result is much improved but suboptimal\] * Improved\[The result is improved but an additional procedure is recommended \] * no difference\[The result is the same when compared with the preoperative state\] * Worse\[The result is worse when compared with the preoperative state\] This module will be administered 3monts and 6 months postoperatively to analyze satisfaction and aesthetic perception of the result.
次要结局
- Change in Irregularity Presence(Baseline and 6 Months)
- Change in Infection existence(1 week, 1 month, 3 months and 6 Months)
- Change in Bruising Status(Baseline ,1 week 1 month,3 months and 6 Months)
- Change in Erythema Presence(Baseline ,1 week ,1 month,3 months and 6 Months)
- Change in Swelling Status(Baseline ,1 week 1month,3 months and 6 Months)