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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 (ā„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 ā„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 VivaceĀ® device (non-insulated microneedles, 3.5 mm depth, 8 W, 600 ms pulse) at 4-week intervals. Primary outcomes were treatment success (ā„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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial Muscle Exercises (FME) | Experimental | Participants received an 8-week facial muscle exercise program consisting of weekly online sessions led by the investigator and daily home exercises. Exercises targeted nasolabial folds and jawline using techniques such as "Big O," "Nasolabial Lift Up," "Nasolabial Smoother," "Rolly Polly," "Swan Neck," and "Pulled Tongue," following the Face Yoga method. |
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| Fractional Microneedling Radiofrequency (FMR) | Experimental | Participants underwent three sessions of fractional microneedling radiofrequency using the VivaceĀ® device at 4-week intervals. Non-insulated microneedles were used with parameters: depth 3.5 mm, power 8 W, pulse duration 800 ms. Local anesthetic cream applied before each session; topical antibiotics and moisturizers used post-procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facial Muscle Exercise Program | Behavioral | Eight-week course with weekly online sessions and daily home exercises demonstrated via video. Exercises aimed to improve facial muscle tone and lifting effect. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success (ā„25% improvement in Physician Global Aesthetic Improvement Score) | Proportion of participants achieving ā„25% improvement in PGAI compared to baseline. | Day 90 (End of Study) |
| Patient Satisfaction | Measured on a 3-point scale (0 = not satisfied, 1 = moderately satisfied, 2 = very satisfied). | Day 90 (End of Study) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Day 30, Day 60, Day 90 |
| Wrinkle Severity Rating Scale (WSRS) |
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Inclusion Criteria:
Exclusion Criteria:
Study included female participants aged 30 years or older with mild to moderate facial aging.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr El Aini Hospital, Cairo, English (English) | Cairo | Cairo Governorate | 11511 | Egypt |
Individual participant data (IPD) will not be shared because this is a single-center study with a small sample size, and de-identification cannot be fully guaranteed. Aggregate results, including summary statistics and outcome analyses, will be made available through publication
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| VivaceĀ® Fractional Microneedling Radiofrequency | Device | 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. |
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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). |
| 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) | Day 30, Day 60, Day 90 |
| Improvement Type | Classification of improvement as "lifting," "texture," or "both" based on blinded dermatologist review. | Day 90 |