A Comparative Split-Face Study of Long-Pulsed 1064-nm Nd:YAG and Fractional CO₂ Laser for Skin Rejuvenation Based on Dermal Thickness, Skin Elasticity, Wrinkle Assessment, and Global Aesthetic Improvement Scale Scores
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Dermal Thickness
研究概览
简要总结
Skin rejuvenation is an effort to improve skin condition from the signs of skin aging. Skin aging is a complex biological process influenced by intrinsic and extrinsic factors, leading to changes in the epidermis and dermis, including decreased collagen characterized by dermal thinning, as well as alterations in skin appearance such as laxity and wrinkles. Laser therapy is one of the treatment modalities for skin rejuvenation, aiming to induce neocollagenesis and collagen remodeling, resulting in dermal thickening and improvement in skin appearance. Fractional CO₂ laser is an ablative laser considered the gold standard therapy for skin rejuvenation, whereas Long Pulsed (LP) Nd:YAG 1064 nm is a nonablative laser that is also used for skin rejuvenation. To date, there have been no studies evaluating the comparative effectiveness between fractional CO₂ laser and LP Nd:YAG 1064 nm for skin rejuvenation. Therefore, research comparing the effectiveness of fractional CO₂ laser and LP Nd:YAG 1064 nm for skin rejuvenation is needed, assessed based on dermal thickness, skin elasticity, wrinkles, and Global Aesthetic Improvement Scale scores.
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 (Investigator)
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients with skin aging classified as Glogau scale II-III
- •Age 30-59 years.
排除标准
- •Pregnant or breastfeeding women.
- •Active smokers.
- •Individuals with high levels of sun exposure.
- •History of facial laser therapy, microdermabrasion, chemical peeling, botulinum toxin injection, microneedling, or skin booster injections within the past six months.
- •Use of oral isotretinoin within the past six months.
- •Use of topical retinoids or their derivatives, topical vitamin C, or other collagen-stimulating and skin-rejuvenating agents within the past two weeks.
- •Use of oral vitamin C, collagen-stimulating supplements, antioxidants, or hormone therapy with skin-rejuvenating effects within the past one month.
- •Presence of active facial skin inflammation.
- •History of keloid formation.
- •History of allergy to topical lidocaine anesthesia.
研究组 & 干预措施
Arm 1
In this split-face study, each participant received fractional CO₂ laser treatment on one side of the face. The treated side was randomly assigned. The procedure was performed three times at one-month intervals.
干预措施: Fractional CO₂ laser (Procedure)
Arm 2
In the same participants, the contralateral side of the face received long-pulsed 1064-nm Nd:YAG laser treatment. The side allocation was randomized. The procedure was performed three times at one-month intervals.
干预措施: Long-pulsed 1064-nm Nd:YAG laser (Procedure)
结局指标
主要结局
Dermal Thickness
时间窗: From enrollment to the end of treatment at 20 weeks
Dermal thickness was assessed based on the two-dimensional area of the hyperechoic band that appears brighter than the epidermis on ultrasonography assessment.
Skin Elasticity
时间窗: From enrollment to the end of treatment at 20 weeks
Skin elasticity was defined as the ability of the skin to return to its original shape after deformation caused by mechanical traction. It was measured using a skin elasticity meter, and the R (recovery) value was assessed at 8 evaluation points on the face.
Wrinkles
时间窗: From enrollment to the end of treatment at 20 weeks
Lines or folds formed on the skin surface as a result of mechanical stress, skin dehydration, or repetitive muscular activity, and were evaluated using a facial skin analyzer
Global Aesthetic Improvement Scale Scores
时间窗: From enrollment to the end of treatment at 20 weeks
A 5-point rating scale (1-5) used to measure the degree of aesthetic improvement in patients following a procedure.
次要结局
未报告次要终点