Fractional Microneedling Radiofrequency Versus Facial Muscle Exercises for Facial Rejuvenation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Treatment Success (≥25% improvement in Physician Global Aesthetic Improvement Score)
研究概览
简要总结
This randomized controlled trial compared the effectiveness and safety of fractional microneedling radiofrequency (FMR) and facial muscle exercises (FME) for facial rejuvenation in females with mild to moderate facial aging. Forty participants aged 32-65 were randomized to either an 8-week FME program or three FMR sessions at 4-week intervals. Outcomes included modified quantitative comprehensive grading scale of aging (MQCGS), wrinkle severity rating scale (WSRS), physician global aesthetic improvement score (PGAI), subject global aesthetic improvement score (SGAIS), and patient satisfaction. Primary endpoints were treatment success (≥25% improvement in PGAI) and patient satisfaction at Day 90. Secondary outcomes assessed changes in aging scores, wrinkle severity, and improvement type (lifting versus texture effects). Ethics approval was obtained from the Research Ethics Committee, Faculty of Medicine, Cairo University.
详细描述
Facial aging involves changes in skin texture, loss of volume, and tissue descent. Fractional microneedling radiofrequency (FMR) delivers controlled thermal injury via microneedles to stimulate collagen and elastin, with proposed benefits for skin texture and firmness. Facial muscle exercises (FME), or face yoga, aim to strengthen facial muscles, enhance tone, and lift sagging tissues. This single-center, outpatient, randomized, active-controlled, parallel-group trial enrolled 40 female participants aged ≥30 years with mild to moderate facial aging. Group A received an 8-week FME program (weekly online sessions plus daily home exercises). Group B underwent three FMR sessions using Vivace® device (non-insulated microneedles, 3.5 mm depth, 8 W, 600 ms pulse) at 4-week intervals. Primary outcomes were treatment success (≥25% improvement in PGAI) and patient satisfaction at Day 90. Secondary outcomes included MQCGS, WSRS, SGAIS, and improvement type (lifting versus texture). The study aimed to compare the two interventions across these outcome measures. Ethics approval was granted by the Research Ethics Committee, Faculty of Medicine, Cairo University; informed consent was obtained from all participants.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged ≥30 years
- •Mild to moderate facial aging (defined as grade 2-3 on Modified Quantitative Comprehensive Grading Scale of Aging and grade 2-4 on Wrinkle Severity Rating Scale)
- •Literate and able to follow instructions
- •Familiar with using online applications (e.g., Zoom) and have reliable internet access
- •Provided written informed consent for participation and photography
排除标准
- •Age <30 years
- •Severe facial aging (grade 4 on MQCGS and grade 5 on WSRS)
- •Current smoker
- •History of previous facelift surgery or thread lifting Botulinum toxin or filler injection within the past 12 months
- •Mesotherapy or topical rejuvenating therapy within the past 3 months
- •Body dysmorphic disorder
- •Medical history of autoimmune diseases, diabetes, or systemic conditions affecting healing
- •Pregnancy or lactation
- •Illiteracy or inability to follow instructions
- •Lack of internet access or inability to use online applications
结局指标
主要结局
Treatment Success (≥25% improvement in Physician Global Aesthetic Improvement Score)
时间窗: Day 90 (End of Study)
Proportion of participants achieving ≥25% improvement in PGAI compared to baseline.
Patient Satisfaction
时间窗: Day 90 (End of Study)
Measured on a 3-point scale (0 = not satisfied, 1 = moderately satisfied, 2 = very satisfied).
次要结局
- Modified Quantitative Comprehensive Grading Scale of Aging (MQCGS)(Baseline, Day 30, Day 60, Day 90)
- Wrinkle Severity Rating Scale (WSRS)(Baseline, Day 30, Day 60, Day 90)
- Subject Global Aesthetic Improvement Score (SGAIS)(Day 30, Day 60, Day 90)
- Improvement Type(Day 90)
研究者
heba ahmed abdelgayed ibrahim
Lecturer of Dermatology
Kasr El Aini Hospital