Facial Muscle Exercises vs Fractional Microneedling Radiofrequency for Facial Rejuvenation

Fractional Microneedling Radiofrequency Versus Facial Muscle Exercises for Facial Rejuvenation: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Facial Aging
• Intervention / Treatment: Behavioral: Facial Muscle Exercise Program; Device: Vivace® Fractional Microneedling Radiofrequency

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11511
      • Kasr El Aini Hospital, Cairo, English (English)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facial Muscle Exercises (FME); 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.	Behavioral: Facial 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.
Experimental: Fractional Microneedling Radiofrequency (FMR); Participants underwent three sessions of fractional microneedling radiofrequency using the Vivace® 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.	Device: Vivace® 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Success (≥25% improvement in Physician Global Aesthetic Improvement Score)	Proportion of participants achieving ≥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)

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): June 10, 2024

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Radiofrequency; Facial rejuvenation; Fractional microneedling radiofrequency; Face yoga; Facial muscle exercises; Non-surgical facelift; Wrinkle reduction; Skin texture improvement
• Other Study ID Numbers: MS-63-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No