Skin AgingNCT06228833
A Clinical Study to Evaluate the Efficacy and Safety of Monopolar Radiofrequency Combined With SkinCeuticals A.G.E and Skinceuticals CE FERULIC for Improving Facial Skin Elasticity, Tightening and Fading Fine Lines
A study testing monopolar radiofrequency, SkinCeuticals A.G.E and Skinceuticals CE FERULIC and Standard Cream in people with Skin Aging, run by Yes Skin Medical Group.
Trial summary
A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and safety of monopolar radiofrequency combined with SkinCeuticals A.G.E and Skinceuticals CE FERULIC for improving facial skin elasticity, tightening and… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- monopolar radiofrequency, SkinCeuticals A.G.E and Skinceuticals CE FERULIC and Standard Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2024to 30 Oct 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be enrolled in the study:
- Healthy women, skin quality is not limited, aged 25 ~ 65 years old face old ~ moderate aging group;
- subjects facial skin rough, loose, lack of elasticity;
- Subjects with multiple facial fine lines, decree lines or puppet lines areas have static fine lines trend, the lower part showed signs of loosening;
- Subjects with consistent facial skin status on both sides and planning to receive monopolar radiofrequency treatment;
- Be able to cooperate well with the tester and maintain the regularity of life during the study;
- Be able to read and understand all contents of the informed consent form, and voluntarily sign the informed consent form (ICF);
- Agreed not to use any cosmetics, drugs and health products that have an impact on the results during the trial;
Who cannot join
- Subjects were not included in the study if they met any of the following exclusion criteria:
- Subjects with contraindications to monopolar radiofrequency treatment (such as malignant tumors, acute systemic infection, metal implants or active implants in the body such as cardiac pacemakers/defibrillators, etc.) or contraindications to A.G.E./CE use (or allergies to other skin care components);
- Subjects with facial skin diseases, infections, inflammation, etc. that may affect the judgment of the test results;
- Subjects with hypertrophic scar or scar constitution;
- Subjects who have experienced tightening medical treatment (Gemma, Fotona 4D, ultrasonic cannon, ultrasonic scalpel, gold microneedle, etc.) in the past 3 months;
- Subjects who have oral and topical cosmetic products that may affect the study results within 2 weeks;
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- Subjects who participate in drug clinical trials or other trials within 30 days, or subjects who have systemic use of drugs that may affect the study results within the past 1 week;
- Pregnant or lactating women, or recent plans to prepare for pregnancy;
- Other subjects who are not suitable for participating in this study as assessed by the investigator.
About this study
Official title: A Prospective, Single-center, Single-blind, Randomized Split-face Controlled Clinical Study to Evaluate the Efficacy and Safety of Monopolar Radiofrequency Combined With SkinCeuticals A.G.E and Skinceuticals CE FERULIC for Improving Facial Skin Elasticity, Tightening and Fading Fine Lines
A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and safety of monopolar radiofrequency combined with SkinCeuticals A.G.E and Skinceuticals CE FERULIC for improving facial skin elasticity, tightening and fading fine lines
- Conditions
- Skin Aging
- Being tested
- monopolar radiofrequency, SkinCeuticals A.G.E and Skinceuticals CE FERULIC, Standard Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monopolar radiofrequencyDevice
Each subject underwent monopolar radiofrequency treatment (Thermage FLX ™ ) on both sides of the face
SkinCeuticals A.G.E and Skinceuticals CE FERULICOther
Test Side receives SkinCeuticals A.G.E and Skinceuticals CE FERULIC
Standard CreamOther
Control Side applies Standard Cream
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Device: monopolar radiofrequency; Other: SkinCeuticals A.G.E and Skinceuticals CE FERULIC |
| Control group | Active comparator | Not described Receives: Device: monopolar radiofrequency; Other: Standard Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global aesthetic improvement scale （GAIS） score
Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse).
Measured: at day 90 after procedure
Secondary outcomes (8)
Global aesthetic improvement scale （GAIS） score
Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse).
Measured: at 30, 60 days after procedure
Improvement of skin glossiness
Skin glossiness was assessed by an independent investigator on both sides of the face (three measurements averaged) according to DermaLab ® Combo (Multipurpose Skin Detector, Cortex) + Chromaticity Test Probe
Measured: at 30, 60, 90 days after procedure
Improvement in skin elasticity and tightness
Skin elasticity was assessed by an independent investigator on both sides of the face (averaged over three measurements) according to the DermaLab ® Combo + Elastic Probe
Measured: at 30, 60, 90 days after procedure
Improvement in dermal thickness/density
Dermal thickness/density was assessed on both sides of the face (averaged over three measurements) by an independent investigator using the DermaLab ® Combo + HF ultrasound probe
Measured: at 30, 60, 90 days after procedure
Improvement of transepidermal water loss (TEWL)
TEWL was assessed by an independent investigator on both sides of the face (three measurements averaged) according to the DermaLab ® Combo + TEWL test probe
Measured: at 30, 60, 90 days after procedure
Improvement of skin stratum corneum water content
Skin stratum corneum moisture was assessed on both sides of the face (three measurements averaged) by an independent investigator using the DermaLab ® Combo + Moisture Testing Probe
Measured: at 30, 60, 90 days after procedure
Improvement in fine lines score
Skin Parameter Assessment Form. Fine lines: Grading was performed on a Griffith 's scale (10-point scale) with different scores representing: 0 (no fine lines/wrinkles, skin completely smooth and no wrinkles); 1-3 (mild, few fine lines and wrinkles, and distant intervals within the treatment area); 4-6 (moderate, moderate number of fine lines/wrinkles within the treatment area and close to each other); and 7-9 (severe, dense clusters of fine lines/wrinkles within the treatment area). Fine lines status should be evaluated by an independent investigator.
Measured: at 30, 60, 90 days after procedure
Subject satisfaction evaluation
Subject Satisfaction Assessment Form. 1: very dissatisfied, 2: dissatisfied, 3: fair, 4: satisfied, and 5: very satisfied, and the proportion of people in each rating was statistically summarized
Measured: at 30, 60, 90 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start30 Jan 2024 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yes Skin Medical Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228833
- Sponsor's protocol ID
- SKCRFAGE002
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-blind, Randomized Split-face Controlled Clinical Study to Evaluate the Efficacy and Safety of Monopolar Radiofrequency Combined With SkinCeuticals A.G.E and Skinceuticals CE FERULIC for Improving Facial Skin Elasticity, Tightening and Fading Fine Lines
- ClinicalTrials.gov ID
- NCT06228833
- Acronym / sponsor ID
- SKCRFAGE002
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yes Skin Medical GroupUniversity, hospital or other
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and safety of monopolar radiofrequency combined with SkinCeuticals A.G.E and Skinceuticals CE FERULIC for improving facial skin elasticity, tightening and fading fine lines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: monopolar radiofrequency, Other: SkinCeuticals A.G.E and Skinceuticals CE FERULIC |
| Control group | Active comparator | Device: monopolar radiofrequency, Other: Standard Cream |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must meet all of the following criteria to be enrolled in the study:
Key exclusion criteria (9 listed)
- Subjects were not included in the study if they met any of the following exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monopolar radiofrequencyEach subject underwent monopolar radiofrequency treatment (Thermage FLX ™ ) on both sides of the face | Device | Control group, Test group |
| SkinCeuticals A.G.E and Skinceuticals CE FERULICTest Side receives SkinCeuticals A.G.E and Skinceuticals CE FERULIC | Other | Test group |
| Standard CreamControl Side applies Standard Cream | Other | Control group |
Primary outcome
Global aesthetic improvement scale （GAIS） score
Time frame: at day 90 after procedure
Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse).
8 secondary outcomes
Global aesthetic improvement scale （GAIS） score
Time frame: at 30, 60 days after procedure
Improvement of skin glossiness
Time frame: at 30, 60, 90 days after procedure
Improvement in skin elasticity and tightness
Time frame: at 30, 60, 90 days after procedure
Improvement in dermal thickness/density
Time frame: at 30, 60, 90 days after procedure
Improvement of transepidermal water loss (TEWL)
Time frame: at 30, 60, 90 days after procedure
Improvement of skin stratum corneum water content
Time frame: at 30, 60, 90 days after procedure
Improvement in fine lines score
Time frame: at 30, 60, 90 days after procedure
Subject satisfaction evaluation
Time frame: at 30, 60, 90 days after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing monopolar radiofrequency, SkinCeuticals A.G.E and Skinceuticals CE FERULIC and Standard Cream in people with Skin Aging, run by Yes Skin Medical Group.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Global aesthetic improvement scale （GAIS） score (time frame: at day 90 after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2024.