Facial Aging
Conditions
Keywords
Facial rejuvenation, Fractional microneedling radiofrequency, Face yoga, Facial muscle exercises, Non-surgical facelift, Radiofrequency, Wrinkle reduction, Skin texture improvement
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFacial Muscle Exercise Program
Eight-week course with weekly online sessions and daily home exercises demonstrated via video. Exercises aimed to improve facial muscle tone and lifting effect.
DEVICEVivace® Fractional Microneedling Radiofrequency
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.
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success (≥25% improvement in Physician Global Aesthetic Improvement Score) | Day 90 (End of Study) | Proportion of participants achieving ≥25% improvement in PGAI compared to baseline. |
| Patient Satisfaction | Day 90 (End of Study) | Measured on a 3-point scale (0 = not satisfied, 1 = moderately satisfied, 2 = very satisfied). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Quantitative Comprehensive Grading Scale of Aging (MQCGS) | Baseline, Day 30, Day 60, Day 90 | 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). |
| Wrinkle Severity Rating Scale (WSRS) | Baseline, Day 30, Day 60, Day 90 | 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). |
| Subject Global Aesthetic Improvement Score (SGAIS) | Day 30, Day 60, Day 90 | 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) |
| Improvement Type | Day 90 | Classification of improvement as lifting, texture, or both based on blinded dermatologist review. |
Countries
Egypt
Outcome results
None listed