Facial Muscle Exercises vs Fractional Microneedling Radiofrequency for Facial Rejuvenation

NCT ID: NCT07285577

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-06-10

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.

Conditions

Facial Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Facial Muscle Exercise Program

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Vivace® Fractional Microneedling Radiofrequency

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

heba ahmed abdelgayed ibrahim

Lecturer of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr El Aini Hospital, Cairo, English (English)

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

MS-63-2022

Identifier Type: -

Identifier Source: org_study_id