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Completed

NCT Number: NCT07285577

Facial Muscle Exercises vs Fractional Microneedling Radiofrequency for Facial Rejuvenation

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.

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Key information

Conditions

Facial Aging

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr El Aini Hospital, Cairo, English (English)

Cairo, Cairo Governorate, 11511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Treatment Success (≥25% improvement in Physician Global Aesthetic Improvement Score)

    Time frame: Day 90 (End of Study)

    Proportion of participants achieving ≥25% improvement in PGAI compared to baseline.

  2. Patient Satisfaction

    Time frame: Day 90 (End of Study)

    Measured on a 3-point scale (0 = not satisfied, 1 = moderately satisfied, 2 = very satisfied).

Secondary outcomes

  1. Modified Quantitative Comprehensive Grading Scale of Aging (MQCGS)

    Time frame: 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).

  2. Wrinkle Severity Rating Scale (WSRS)

    Time frame: 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).

  3. Subject Global Aesthetic Improvement Score (SGAIS)

    Time frame: 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)

  4. Improvement Type

    Time frame: Day 90

    Classification of improvement as "lifting," "texture," or "both" based on blinded dermatologist review.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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