Facial Muscle Exercises vs Fractional Microneedling Radiofrequency for Facial Rejuvenation

NCT07285577 | Completed

• 1 other identifier: MS-63-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Aging

Keywords

Facial rejuvenation; Fractional microneedling radiofrequency; Face yoga; Facial muscle exercises; Non-surgical facelift; Radiofrequency; Wrinkle reduction; Skin texture improvement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

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.

Behavioral: Facial Muscle Exercise Program

Fractional Microneedling Radiofrequency (FMR)

EXPERIMENTAL

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

Interventions

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.

Facial Muscle Exercises (FME)

Vivace® 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.

Fractional Microneedling Radiofrequency (FMR)

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: Study included female participants aged 30 years or older with mild to moderate facial aging.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Aini Hospital, Cairo, English (English)

Cairo, Cairo Governorate, 11511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 16, 2025
• Study Start: April 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 10, 2024
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)