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Facial RejuvenationNCT07753564

Unipolar Radiofrequency Treatment Combined With SkinCeuticals A.G.E. Ultra Cream for Facial Rejuvenation

A study of Facial Rejuvenation, run by Beijing Artemis Medical Beauty Clinic at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To evaluate the efficacy and safety of monopolar radiofrequency treatment combined with SkinCeuticals A.G.E. Ultra Cream for facial rejuvenation Read more about this study

Who is it for?
Ages 30 to 60 years, women only
Conditions the study is for
Facial Rejuvenation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
29 May 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female, aged 30-60 years;
  • Fine lines on both sides of the forehead meet Grade 1-5 according to the Skin Aging Atlas;
  • Crow's feet on both sides meet Grade 2-5 according to the Skin Aging Atlas;
  • Perioral wrinkles on both sides meet Grade 1-7 or nasolabial folds on both sides meet Grade 1-6 according to the Skin Aging Atlas;
  • Lower facial laxity and sagging meet Grade 1-5 according to the Skin Aging Atlas;
  • Subjects with consistent skin condition on both sides of the face who are scheduled to receive unipolar radiofrequency treatment;
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  • Able to comply well with the study requirements and maintain a regular lifestyle throughout the study period;
  • Able to read and understand all contents of the informed consent form and voluntarily sign the ICF;
  • Agree not to use any cosmetics, medications, or health supplements that may affect the study results during the trial period.

Who cannot join

  • Allergic constitution or history of severe allergies (e.g., immediate hypersensitivity symptoms, allergic dermatitis);
  • Presence of facial skin diseases (including severe freckles, atopic dermatitis, psoriasis, acute eczema, severe acne, etc.), skin infections (including viral, bacterial, fungal), or skin masses of unknown nature;
  • Presence of large areas of birthmarks, scratch marks, vitiligo, pigmented nevi, keloids, or other skin manifestations on the face that may affect the evaluation;
  • Presence of implantable electronic devices in the body (e.g., pacemaker, implantable cardioverter-defibrillator);
  • Diagnosed with serious clinical conditions such as endocrine diseases, immune system diseases, severe organ failure, or malignant tumors;
  • Diagnosed with severe mental illness or cognitive dysfunction, deemed by the investigator as unable to complete the evaluation or questionnaires involved in the study;
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  • Received or planned to receive facial radiofrequency or botulinum toxin treatment within 6 months prior to enrollment or during the study;
  • Received chemotherapy or systemic corticosteroids within 3 months prior to enrollment;
  • Received or planned to receive facial photoelectric treatments (e.g., laser, intense pulsed light), fillers (e.g., sodium hyaluronate, collagen), thread lifts, or other aesthetic procedures within 3 months prior to enrollment or during the study;
  • Received or planned to receive facial mesotherapy or chemical peeling within 1 month prior to enrollment or during the study;
  • Used cosmetics, skincare products, or topical medications with firming or anti-wrinkle claims (e.g., glycolic acid, salicylic acid, mandelic acid, tretinoin, hydroquinone, azelaic acid, adapalene, etc.) on the face within 14 days prior to enrollment;
  • Other conditions that, in the investigator's judgment, render the subject unsuitable for unipolar radiofrequency treatment;
  • Pregnant or breastfeeding women;
  • Participated in other interventional clinical trials within 1 month prior to enrollment;
  • Other circumstances under which the investigator considers the subject should not participate in this clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Beijing Artemis Medical Beauty Clinic

    Beijing, Beijing Municipality

    Xiaoge Ma, +86 010-65666810, 1621525631@qq.com

    Lanping Pu

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-center, Single-blind, Randomized Split-face Controlled Clinical Study Evaluating the Efficacy and Safety of Unipolar Radiofrequency Treatment Combined With SkinCeuticals A.G.E. Ultra Cream for Facial Rejuvenation

To evaluate the efficacy and safety of monopolar radiofrequency treatment combined with SkinCeuticals A.G.E. Ultra Cream for facial rejuvenation

Read the detailed description

Facial aging is a multidimensional process that progresses with age, involving the synergistic degenerative changes of the skin, soft tissues, and skeletal structure. Its typical features include skin laxity, deepening of fine lines and wrinkles, rough texture, and dull complexion. Among these, the loss of collagen and elastin in the dermis is considered the core mechanism underlying reduced skin firmness and the formation of fine lines. Collagen loss is generally caused by a combination of intrinsic and extrinsic factors. Intrinsically, as age increases, the function of fibroblasts in the skin gradually declines, reducing their capacity to synthesize collagen, which leads to thinning of the dermis and decreased skin elasticity, manifesting as roughness and laxity. In addition, glycation plays a significant role in skin aging. Under a high-glucose environment, advanced glycation end products (AGEs) are prone to form in the skin, which stiffen the collagen structure, reduce elasticity, and impair repair capacity. AGEs further compromise fibroblast function, decreasing collagen production while increasing its degradation, ultimately exacerbating skin laxity and wrinkle formation . Among extrinsic factors, chronic ultraviolet exposure is a major accelerator of skin aging. Ultraviolet radiation induces oxidative damage and inflammatory responses in the skin, promoting collagen degradation while inhibiting its synthesis, thereby significantly accelerating the aging process. Under the combined influence of these factors, skin hydration and barrier function progressively decline, clinically presenting as uneven skin tone, reduced radiance, and accelerated aging. In terms of visual appearance, skin aging is mainly characterized by deepened wrinkles, decreased firmness, and increased laxity, particularly pronounced in the forehead, periorbital area, perioral region, and facial contour. These aging manifestations, marked by wrinkle formation and skin laxity, highlight the necessity of improving skin firmness and contour through medical aesthetic interventions, and further demonstrate the value of monopolar radiofrequency treatment in facial rejuvenation.

Monopolar radiofrequency (i.e., Thermage®), as a non-invasive anti-aging technology, delivers radiofrequency energy to the dermis, causing immediate contraction of collagen fibers and stimulating fibroblasts to promote subsequent collagen neogenesis, thereby improving skin firmness, contour laxity, and fine lines. A substantial body of literature indicates that monopolar radiofrequency treatment produces stable and reproducible clinical outcomes in terms of facial tightening, tissue lifting, and improvement of superficial wrinkles, with a favorable safety profile, making it one of the most widely used skin anti-aging radiofrequency devices. However, although radiofrequency treatment can achieve collagen remodeling, its effects on the skin barrier, radiance, and deep AGEs are limited. Therefore, combining radiofrequency treatment with skincare products that possess anti-glycation, reparative, and collagen-promoting properties may further enhance facial rejuvenation outcomes.

Currently, there is no unified, systematic clinical pathway for comprehensive skin management following non-invasive energy-based medical aesthetic procedures such as radiofrequency and focused ultrasound. To address this clinical need, SkinCeuticals has taken the lead in recent years in proposing the concept of "holistic skincare" and has formulated the Chinese Clinical Practice Expert Consensus on Peri-Procedural Holistic Skincare for Non-Invasive Energy-Based Medical Aesthetic Procedures. According to the consensus, holistic skincare refers to the systematic integration of functional skincare products into the skin management workflow during the peri-procedural period of non-invasive energy-based aesthetic treatments, covering the phases before treatment, immediately after treatment, and subsequent home maintenance. The expert consensus notes that while energy-based treatments such as radiofrequency improve skin firmness, they may also affect the skin barrier to some extent and are accompanied by oxidative, glycative, and inflammatory responses, making targeted skincare intervention necessary for comprehensive management. SkinCeuticals A.G.E. Ultra Cream, as a key component of the holistic skincare framework, is formulated around glycation-related aging pathways, covering multiple key dimensions including anti-glycation, promotion of multiple types of collagen production, and support of skin barrier stability. The flavonoid components and dipotassium glycyrrhizate in its compound anti-glycation concentrate help mitigate glycation effects, reduce collagen glycation damage, and block AGE formation pathways, thereby lowering the risk of collagen structural and functional deterioration. Meanwhile, ingredients such as pro-xylane solution, rhamnose, and Gentiana lutea root extract in the formula help support fibroblast activity and participate in the synthesis and tissue remodeling of key structural proteins including type IV, type VII, and type XVII collagen. This contributes to improving skin firmness while maintaining skin barrier stability and overall skin condition. Existing clinical studies have shown that SkinCeuticals A.G.E. Ultra Cream can effectively reduce facial wrinkles, improve skin elasticity, and ameliorate sagging manifestations, providing scientific evidence for comprehensive skin management following non-invasive energy-based aesthetic treatments. Based on the above mechanisms of skin aging and the characteristics of holistic skincare, this study adopts a combined intervention model of monopolar radiofrequency treatment plus SkinCeuticals A.G.E. Ultra Cream, incorporating both subjective efficacy indicators and skin physiological parameters to validate the efficacy and synergistic effects of SkinCeuticals A.G.E. Ultra Cream, thereby providing cutting-edge clinical evidence for the concept of holistic skincare.

Being tested
Left face A.G.E+Right face control, Right face A.G.E+Left face control

What participants receive

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

  • Left face A.G.E+Right face controlOther

    The left side of the face serves as the experimental side, and the right side serves as the control side. The experimental side uses SkinCeuticals A.G.E. Ultra Cream, while the control side uses a standard cream.

  • Right face A.G.E+Left face controlOther

    The left side of the face serves as the control side, and the right side serves as the experimental side. The experimental side uses SkinCeuticals A.G.E. Ultra Cream, while the control side uses a standard cream.

Study groups in NCT07753564
Study groupRoleWhat they receive
Left face A.G.E+Right face controlOtherThe left side of the face serves as the experimental side, and the right side serves as the control side. The experimental side uses SkinCeuticals A.G.E. Ultra Cream, while the control side uses a standard cream.
Receives: Other: Left face A.G.E+Right face control
Right face A.G.E+Left face controlOtherThe left side of the face serves as the control side, and the right side serves as the experimental side. The experimental side uses SkinCeuticals A.G.E. Ultra Cream, while the control side uses a standard cream.
Receives: Other: Right face A.G.E+Left face control

What is being measured

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

  1. Investigator Global Aesthetic Improvement Scale (GAIS) assessment at 12 weeks post-treatment

    The blinded evaluator will assess subjects using the Global Aesthetic Improvement Scale (GAIS). The scale contains two questions: 1. Global aesthetic improvement - left side, and 2. Global aesthetic improvement - right side. Each question is rated on a 5-level scale: Level 1 = Very marked improvement, Level 2 = Marked improvement, Level 3 = Somewhat improved, Level 4 = No change, and Level 5 = Worse than before. The minimum value is 1 per item, and the maximum value is 5 per item. A lower score indicates a better outcome, meaning higher scores represent a worse outcome.

    Measured: 12 weeks (±7 days) post-treatment

Secondary outcomes (13)
  1. Global Aesthetic Improvement Scale (GAIS) assessment

    The blinded evaluator will assess subjects using the Global Aesthetic Improvement Scale (GAIS). The scale contains two questions: 1. Global aesthetic improvement - left side, and 2. Global aesthetic improvement - right side. Each question is rated on a 5-level scale: Level 1 = Very marked improvement, Level 2 = Marked improvement, Level 3 = Somewhat improved, Level 4 = No change, and Level 5 = Worse than before. The minimum value is 1 per item, and the maximum value is 5 per item. A lower score indicates a better outcome, meaning higher scores represent a worse outcome.

    Measured: 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment

  2. Patient satisfaction with treatment

    The assessment uses a Subject Satisfaction Questionnaire. The questionnaire contains 5 identical questions to be evaluated separately for the left and right sides of the face. The 5 questions are:

    1. Satisfaction with the overall skin care effects of the Thermage procedure.
    2. Overall improvement in facial wrinkles after using the product.
    3. Improvement in facial skin elasticity after using the product.
    4. Improvement in facial skin plumpness after using the product.
    5. Improvement in skin hydration after using the product.

    Each question is rated on a 5-level scale, with scores as follows:

    1. point - Very Dissatisfied
    2. points - Dissatisfied
    3. points - Neutral / Average
    4. points - Satisfied
    5. points - Very Satisfied

    Higher Score Means: Better outcome (higher satisfaction)

    Measured: 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment

  3. Improvement in skin elasticity and firmness

    The investigator will assess the skin on both sides of the face using the CK Skin Analyzer with a Cutometer probe; a single measurement will be taken

    Measured: Screening period, 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment, 12 weeks (±7 days) post-treatment

  4. Improvement in transepidermal water loss

    The investigator will assess transepidermal water loss on both sides of the face using the CK Skin Analyzer with a Vapometer probe. Measurements will be taken twice, and the average value will be used as the final result.

    Measured: Screening period, 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment, 12 weeks (±7 days) post-treatment

  5. Improvement in skin hydration

    The investigator will assess transepidermal water loss on both sides of the face using the CK Skin Analyzer with a moisture content probe. Measurements will be taken three times, and the average value will be used as the final result.

    Measured: Screening period, 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment, 12 weeks (±7 days) post-treatment

  6. Improvement in skin glossiness

    The investigator will assess skin glossiness on both sides of the face using the CK Skin Analyzer with a Glossymeter probe. Measurements will be taken three times, and the average value will be used as the final result.

    Measured: Screening period, 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment, 12 weeks (±7 days) post-treatment

  7. Improvement in dermal thickness and density

    The investigator will assess the thickness and density of both sides of the face using a skin ultrasound device; a single measurement will be taken.

    Measured: Screening period, 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment, 12 weeks (±7 days) post-treatment

  8. Improvement in the number and volume of nasolabial folds

    The investigator will assess the number and volume of wrinkles on both sides of the face nasolabial folds using the Antera 3D imaging system.

    Measured: Screening period, 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment, 12 weeks (±7 days) post-treatment

  9. Improvement in jowl volume

    The investigator will assess the jowl area on both sides of the face using the Antera 3D imaging system.

    Measured: Screening period, 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment, 12 weeks (±7 days) post-treatment

  10. Area percentage of nasolabial folds, crow's feet, and marionette lines

    The investigator will assess the area percentage of wrinkles at three sites on both sides of the face (crow's feet, nasolabial folds, and marionette lines) using the VISIA Skin Analysis System.

    Measured: Screening period, 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment, 12 weeks (±7 days) post-treatment

  11. Improvement in skin AGEs

    The investigator will assess the AGEs index on both sides of the face using the AGE Reader; a single measurement will be taken.The indicator measured by the AGE Reader is typically expressed in AU (Arbitrary Units) and reflects the accumulation level of Advanced Glycation End Products (AGEs) in skin tissue. AGEs are the products of non-enzymatic reactions between proteins or lipids and sugars. A lower value generally indicates less accumulation of AGEs, suggesting a better metabolic state, lower levels of oxidative stress and glycation reactions, and a relatively lower risk of skin aging.

    Measured: Screening period, 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment, 12 weeks (±7 days) post-treatment

  12. Improvement in the number and volume of crow's feet

    The investigator will assess the number and volume of wrinkles on both sides of the face crow's feet using the Antera 3D imaging system.

    Measured: Screening period, 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment, 12 weeks (±7 days) post-treatment

  13. Improvement in the number and volume of marionette lines

    The investigator will assess the number and volume of wrinkles on both sides of the face marionette lines using the Antera 3D imaging system.

    Measured: Screening period, 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-treatment, 12 weeks (±7 days) post-treatment

Timeline

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

  1. First posted7 Aug 2026
  2. Study start29 May 2026
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07753564
Sponsor's protocol ID
21536062511
Status last verified
Aug 2026
First submitted
22 Jul 2026
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study of Facial Rejuvenation, run by Beijing Artemis Medical Beauty Clinic at 1 site in China.

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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Xiaoge Ma (+86 010-65666810, 1621525631@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator Global Aesthetic Improvement Scale (GAIS) assessment at 12 weeks post-treatment (time frame: 12 weeks (±7 days) post-treatment). 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 7 Aug 2026.

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