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Facial AgingNCT07285577

Facial Muscle Exercises vs Fractional Microneedling Radiofrequency for Facial Rejuvenation

A study testing Facial Muscle Exercise Program and Vivace® Fractional Microneedling Radiofrequency in people with Facial Aging, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older, women only
Conditions the study is for
Facial Aging
What is being tested?
Facial Muscle Exercise Program and Vivace® Fractional Microneedling Radiofrequency
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Apr 2023to 10 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Kasr El Aini Hospital, Cairo, English (English)

    Cairo, Cairo Governorate, 11511

Other trials in Egypt

About this study

Official title: 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.

Read the 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
Being tested
Facial Muscle Exercise Program, Vivace® Fractional Microneedling Radiofrequency
Keywords
Facial rejuvenation, Fractional microneedling radiofrequency, Face yoga, Facial muscle exercises, Non-surgical facelift, Radiofrequency, Wrinkle reduction, Skin texture improvement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Facial Muscle Exercise ProgramBehavioural

    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 RadiofrequencyDevice

    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.

Study groups in NCT07285577
Study groupRoleWhat they receive
Facial Muscle Exercises (FME)ExperimentalParticipants 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.
Receives: Behavioral: Facial Muscle Exercise Program
Fractional Microneedling Radiofrequency (FMR)ExperimentalParticipants 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.
Receives: Device: Vivace® Fractional Microneedling Radiofrequency

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Day 90 (End of Study)

  2. Patient Satisfaction

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

    Measured: Day 90 (End of Study)

Secondary outcomes (4)

  1. 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).

    Measured: Baseline, Day 30, Day 60, Day 90

  2. 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).

    Measured: Baseline, Day 30, Day 60, Day 90

  3. 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)

    Measured: Day 30, Day 60, Day 90

  4. Improvement Type

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

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start1 Apr 2023
  3. Primary completion1 Feb 2024
  4. Study completion10 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07285577
Sponsor's protocol ID
MS-63-2022
Status last verified
Dec 2025
First submitted
10 Dec 2025
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Questions about this trial

What is this clinical trial studying?

A study testing Facial Muscle Exercise Program and Vivace® Fractional Microneedling Radiofrequency in people with Facial Aging, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Success (≥25% improvement in Physician Global Aesthetic Improvement Score) (time frame: Day 90 (End of Study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07285577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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