NCT05813483尚未招募不适用
A Prospective, Single-Center, Single-Blind, Randomized Split-Face Controlled Clinical Study to Evaluate the Efficacy and Satisfaction of the Skinceuticals Skin Care Product (CE) for Skin Repair Post Fraxel Laser Treatment in Real World Clinical Practice
DeYi Aesthetic Medical Clinic0 个研究点目标入组 50 人开始时间: 2023年4月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Change in erythema score
研究概览
简要总结
A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and satisfaction of the Skinceuticals skin care product (CE) for skin repair following fraxel laser treatment and explore the medical value of fraxel laser therapy combined with Skinceuticals skin care product
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese subjects aged 18-65 years (inclusive);
- •Subjects with Fitzpatrick skin type II-IV;
- •Subjects with consistent facial skin status on both sides and planned to receive fraxel laser treatment;
- •Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;
- •Subjects understand the nature of the study and sign the informed consent form (ICF).
排除标准
- •Subjects with photosensitive skin or photosensitization-related diseases;
- •Subjects with a history of skin pigmentation, such as pigmentation caused by sex hormone factors (pregnancy, oral contraceptives);
- •Subjects with hypertrophic scar or scar constitution;
- •Subjects with autoimmune diseases, endocrine diseases or liver diseases that may lead to skin color changes;
- •Subjects who have received steroid/phototoxic drugs or laser treatment on the face within 3 months before enrollment;
- •Subjects with a history of sun exposure within 2 weeks prior to enrollment;
- •Subjects who are known to be contraindicated to fraxel laser therapy or CE (or allergic to other skin care components);
- •Subjects with known infection and inflammation in the intended treatment site;
- •Female subjects who are pregnant, lactating or plan to become pregnant;
- •Subjects who plan to use other drugs affecting skin color or intend to undergo other laser therapy and sunbathing during the treatment;
- •Subjects who are participating in other drug or medical device clinical trials;
- •Other subjects who are not suitable for this study as assessed by the investigator
结局指标
主要结局
Change in erythema score
时间窗: at day 7 post-procedure
Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)
次要结局
- Change from baseline in erythema score(days 1, 3, 5 post-procedure)
- Change from baseline in edema score(days 1, 3, 5 ,7 post-procedure)
- Change from baseline in Erythema Index (EI)(days 1, 3, 5 ,7 post-procedure)
- Change from baseline in melanin index(MI) Change from baseline in melanin index(MI)(days 1, 3, 5 ,7 post-procedure)
- Change from baseline in stratum corneum water content(days 1, 3, 5 ,7 post-procedure)
- Change from baseline in transepidermal water loss(days 1, 3, 5 ,7 post-procedure)
- Change from baseline in sebum rate(days 1, 3, 5 ,7 post-procedure)
- Subjects overall satisfaction(days 1, 3, 5 ,7 post-procedure)
研究者
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