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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Eight-week course with weekly online sessions and daily home exercises demonstrated via video. Exercises aimed to improve facial muscle tone and lifting effect.
Three sessions spaced 4 weeks apart; non-insulated microneedles; depth 3.5 mm; power 8 W; pulse 800 ms; pre-treatment topical anesthesia; post-treatment care with antibiotics and moisturizers.
Kasr El Aini Hospital, Cairo, English (English)
Cairo, Cairo Governorate, Egypt
Treatment Success (≥25% improvement in Physician Global Aesthetic Improvement Score)
Proportion of participants achieving ≥25% improvement in PGAI compared to baseline.
Time frame: Day 90 (End of Study)
Patient Satisfaction
Measured on a 3-point scale (0 = not satisfied, 1 = moderately satisfied, 2 = very satisfied).
Time frame: Day 90 (End of Study)
Modified Quantitative Comprehensive Grading Scale of Aging (MQCGS)
Change from baseline in Modified Quantitative Comprehensive Grading Scale of Aging (MQCGS) score. Scale range: 0-33 points, with higher scores indicating more severe facial aging (worse outcome).
Time frame: Baseline, Day 30, Day 60, Day 90
Wrinkle Severity Rating Scale (WSRS)
Change from baseline in Wrinkle Severity Rating Scale (WSRS) score for nasolabial folds. Scale range: 1-5, with higher scores indicating more severe wrinkles (worse outcome).
Time frame: Baseline, Day 30, Day 60, Day 90
Subject Global Aesthetic Improvement Score (SGAIS)
Patient-reported improvement compared to baseline using Subject Global Aesthetic Improvement Score (SGAIS). Scale range: -1 to +3, with higher scores indicating greater improvement (better outcome). (-1 = worse, 0 = no change, +1 = improved, +2 = much improved, +3 = very much improved)
Time frame: Day 30, Day 60, Day 90
Improvement Type
Classification of improvement as "lifting," "texture," or "both" based on blinded dermatologist review.
Time frame: Day 90
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