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临床试验/NCT07376148
NCT07376148招募中4 期

Fractional CO2 Laser-assisted Delivery of Hyaluronic Acid, Ascorbic Acid and Sodium DNA For Enhancing Facial Skin Quality in Individuals Over the Age of 30

Instituto de Oftalmología Fundación Conde de Valenciana1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月7日最近更新:
干预措施

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Skin quality

研究概览

简要总结

Evaluate the effectiveness of topical hyaluronic acid, ascorbic acid, and sodium DNA following ablative fractional laser treatment in objectively reversing facial skin alterations induced by photoaging.

详细描述

The study involves the application of ascorbic acid, hyaluronic acid, and sodium DNA in preparation for their use following the administration of a fractional CO2 laser treatment. Participants will attend a total of four sessions. During the initial session, participants will complete and sign a consent form, baseline photographs will be captured for documentation purposes, and an initial assessment will be conducted using the SASSQ. At the second session, the fractional CO2 laser will be applied, followed by the application of the topical medication to the facial area. During the third and fourth sessions, scheduled one week and four weeks post-treatment, respectively, the facial dermal effects will be objectively evaluated using the SASSQ scale, and any adverse effects will be assessed and documented through photographs.

To facilitate the analysis and comparison of variables, an analysis of variance will be conducted utilizing the ANOVA test for repeated measures. The IBM SPSS Statistics software, version 29.0, will be employed for this purpose. A p-value of less than 0.05 will be regarded as statistically significant.

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
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female subjects, over 30 years of age, with moderate skin changes associated with elasticity, wrinkles, roughness, pigmentation, erythema, and pore size; with at least 12 points on the SASSQ scale. Fitzpatrick skin type I-III. Participants who agree to take part in the protocol

排除标准

  • Fitzpatrick skin type IV-VI. Local infections or inflammatory disorders.. Neoplasms suspected of being malignant. Allergy to hyaluronic acid, ascorbic acid, and sodium DNA. Hypersensitivity to fractional CO2 laser. Pregnancy or breastfeeding. Local or systemic adverse reaction

研究组 & 干预措施

Application of ascorbic acid, hyaluronic acid, and sodium DNA in preparation for their use following

Experimental

Participants will attend a total of four sessions. During the initial session, participants will complete and sign a consent form, baseline photographs will be captured for documentation purposes, and an initial assessment will be conducted using the SASSQ. At the second session, the fractional CO2 laser will be applied, followed by the application of the topical medication to the facial area. During the third and fourth sessions, scheduled one week and four weeks post-treatment, respectively, the facial dermal effects will be objectively evaluated using the SASSQ scale, and any adverse effects will be assessed and documented through photographs.

干预措施: topical hyaluronic acid, ascorbic acid, and sodium DNA following ablative fractional laser treatment (Drug)

结局指标

主要结局

Skin quality

时间窗: From enrollment to the end of treatment at 4 weeks

Quantitative enhancement that can be assessed using a validated scale (SASSQ)

次要结局

未报告次要终点

研究者

发起方
Instituto de Oftalmología Fundación Conde de Valenciana
申办方类型
Other
责任方
Sponsor

研究点 (1)

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