Facial Rejuvenation
Conditions
Brief summary
To evaluate the efficacy and safety of monopolar radiofrequency treatment combined with SkinCeuticals A.G.E. Ultra Cream for facial rejuvenation
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.
Interventions
OTHERLeft face A.G.E+Right face control
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.
OTHERRight face A.G.E+Left face control
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.
Sponsors
Beijing Artemis Medical Beauty Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
To prevent the efficacy evaluator's knowledge of the group allocation from influencing their GAIS assessment, this clinical trial implemented blinding for the efficacy evaluator. The blinded evaluator is defined as a researcher who does not participate in the screening or intervention procedures of this study but conducts the efficacy evaluation. Their sole responsibility is to perform the GAIS assessment for subjects; they are not involved in any other aspects of this trial. The research documents completed by this evaluator are kept independent from those of the unblinded researchers, ensuring that the evaluator cannot obtain any information regarding the subjects' group allocation, thereby maintaining blinding of the group assignment. The blinded evaluator must not actively or passively acquire any information about the subjects' group allocation, and all other unblinded personnel must keep the blinding information confidential from the blinded evaluator. The blinded evaluator shal
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Female, aged 30-60 years; 2. Fine lines on both sides of the forehead meet Grade 1-5 according to the Skin Aging Atlas; 3. Crow's feet on both sides meet Grade 2-5 according to the Skin Aging Atlas; 4. 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; 5. Lower facial laxity and sagging meet Grade 1-5 according to the Skin Aging Atlas; 6. Subjects with consistent skin condition on both sides of the face who are scheduled to receive unipolar radiofrequency treatment; 7. Able to comply well with the study requirements and maintain a regular lifestyle throughout the study period; 8. Able to read and understand all contents of the informed consent form and voluntarily sign the ICF; 9. Agree not to use any cosmetics, medications, or health supplements that may affect the study results during the trial period.
Exclusion criteria
1. Allergic constitution or history of severe allergies (e.g., immediate hypersensitivity symptoms, allergic dermatitis); 2. 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; 3. Presence of large areas of birthmarks, scratch marks, vitiligo, pigmented nevi, keloids, or other skin manifestations on the face that may affect the evaluation; 4. Presence of implantable electronic devices in the body (e.g., pacemaker, implantable cardioverter-defibrillator); 5. Diagnosed with serious clinical conditions such as endocrine diseases, immune system diseases, severe organ failure, or malignant tumors; 6. Diagnosed with severe mental illness or cognitive dysfunction, deemed by the investigator as unable to complete the evaluation or questionnaires involved in the study; 7. Received or planned to receive facial radiofrequency or botulinum toxin treatment within 6 months prior to enrollment or during the study; 8. Received chemotherapy or systemic corticosteroids within 3 months prior to enrollment; 9. 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; 10. Received or planned to receive facial mesotherapy or chemical peeling within 1 month prior to enrollment or during the study; 11. 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; 12. Other conditions that, in the investigator's judgment, render the subject unsuitable for unipolar radiofrequency treatment; 13. Pregnant or breastfeeding women; 14. Participated in other interventional clinical trials within 1 month prior to enrollment; 15. Other circumstances under which the investigator considers the subject should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Aesthetic Improvement Scale (GAIS) assessment at 12 weeks post-treatment | 12 weeks (±7 days) 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Aesthetic Improvement Scale (GAIS) assessment | 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) 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. |
| Patient satisfaction with treatment | 1 week (±2 days) post-treatment, 2 weeks (±2 days) post-treatment, 4 weeks (±7 days) post-treatment, 8 weeks (±7 days) post-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) |
| Improvement in skin elasticity and firmness | 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 | 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 |
| Improvement in transepidermal water loss | 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 | 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. |
| Improvement in skin hydration | 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 | 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. |
| Improvement in skin glossiness | 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 | 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. |
| Improvement in dermal thickness and density | 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 | 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. |
| Improvement in the number and volume of nasolabial folds | 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 | The investigator will assess the number and volume of wrinkles on both sides of the face nasolabial folds using the Antera 3D imaging system. |
| Improvement in jowl volume | 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 | The investigator will assess the jowl area on both sides of the face using the Antera 3D imaging system. |
| Area percentage of nasolabial folds, crow's feet, and marionette lines | 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 | 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. |
| Improvement in skin AGEs | 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 | 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. |
| Improvement in the number and volume of crow's feet | 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 | 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. |
| Improvement in the number and volume of marionette lines | 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 | The investigator will assess the number and volume of wrinkles on both sides of the face marionette lines using the Antera 3D imaging system. |
Countries
China
Contacts
CONTACTXiaoge Ma
Outcome results
None listed