Skin Aging, Facial Rhytides, Skin Tone
Conditions
Keywords
Radiofrequency Microneedling, Biosome, Exosome, Facial aging
Brief summary
This prospective, randomized controlled study evaluated the efficacy and tolerability of AnteAGE Biosome Solution used in conjunction with facial radiofrequency microneedling. Eligible participants with facial rhytids and/or uneven skin tone and texture were randomized 1:1 to an active treatment group or a control group. All participants underwent facial radiofrequency microneedling. Participants in the active group received AnteAGE Biosome Solution during treatment and an AnteAGE skincare regimen, while control participants received hyaluronic acid as the treatment glide and control skincare products. Clinical outcomes included standardized facial photography, investigator assessments, Global Aesthetic Improvement Scale assessments, participant-reported outcomes, and assessment of adverse reactions and post-procedure healing through Day 60.
Detailed description
Participants were randomized 2:1 to an active Biosome treatment group or a control group. All participants underwent one facial radiofrequency microneedling treatment using the Exion Fractional Radiofrequency device. Participants assigned to the active group received AnteAGE Biosome Treatment Solution applied during the radiofrequency microneedling procedure. The solution was used as a topical glide and was reapplied as needed during treatment. Active participants subsequently used a study-supplied skincare regimen including cleanser, moisturizer, sunscreen, AnteAGE Biosome Serum and AnteAGE Serum/Accelerator homecare. Participants assigned to the control group received hyaluronic acid as the topical glide during radiofrequency microneedling and subsequently used control cleanser, moisturizer, sunscreen and control homecare. Participants were evaluated at baseline/treatment and at follow-up visits on Days 1, 3, 7, 30 and 60. Assessments included adverse reactions, standardized facial photography using the VISIA imaging system, participant assessments of facial skin, investigator assessments, and Global Aesthetic Improvement Scale assessments. Selected participants also underwent skin biopsy collection for exploratory histological assessment.
Interventions
OTHERAnteAGE Biosome Treatment Solution
AnteAGE Biosome Treatment Solution was applied to the facial treatment area during radiofrequency microneedling and used as the topical glide, with additional application as needed during treatment.
All participants received one facial radiofrequency microneedling treatment using the EXION Fractional Radiofrequency device. The radiofrequency microneedling procedure was common to both study groups and was not the investigational variable..
Participants used study-supplied cleanser, moisturizer, sunscreen, AnteAGE Biosome Serum, and AnteAGE Accelerator as directed during the post-treatment study period.
Sponsors
Cellese Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Investigator assessment of Global Aesthetic Improvement Scale outcomes was performed by two blinded investigators using standardized facial photography.
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female and male participants 30 to 70 years of age. * Fitzpatrick skin types I-V. * Presence of measurable facial rhytids and/or uneven skin tone and texture as determined by the investigator. * Able and willing to comply with all study visits, procedures and requirements. * Willing to refrain from additional or new facial topical products or procedures, including neurotoxins, fillers or chemical peels, during study participation. * Able to understand and provide written informed consent.
Exclusion criteria
* Use of isotretinoin, oral or topical steroids, or other medications or topical agents considered by the investigator to affect skin or study outcomes. * Presence of inflammatory diseases including lupus erythematosus, scleroderma, dermatitis or eczema; flat warts; acute or chronic skin conditions; skin infections; cancerous or precancerous lesions; or broken skin. * History of keloid scarring. * Conditions that darken skin tone, including Addison's disease or Cushing's syndrome. * Thyrotoxicosis or primary biliary cirrhosis. * Use of medications that may cause hyperpigmentation, including chemotherapy, hydroxychloroquine, gold or colloidal silver. * Use of prescription medications causing photosensitivity. * Immunocompromised participants or those with a history of allergic reactions. * Women who changed contraception within the previous 3 months or began hormone replacement therapy within the previous 3 months. * Currently pregnant or nursing. * History or presence of unstable or chronic disease including cancer or significant lung, kidney, heart, endocrine, hemophilia or other clotting disorders, or metabolic disease. * Participants with implanted electronic devices such as a pacemaker or defibrillator. * Known allergy to numbing agents including benzocaine, lidocaine or tetracaine, or unwilling/unable to consent to use of alternative anesthetic measures. * Known allergy to nuts, permanent makeup, piercings in the treatment area, or other significant procedures in the treatment area within the previous 12 months. * Dermal filler, fat or botulinum toxin injections, or minimally invasive/invasive skin treatment in the procedure area within the previous 4 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Procedure Skin Reaction Severity | Days 1, 3, and 7 after treatment | Severity of post-procedure skin reactions assessed using a 5-point ordinal scale (0 = none, 1 = barely perceptible, 2 = mild, 3 = moderate, 4 = severe). Assessed symptoms included erythema, swelling, ecchymosis, stinging/burning, dryness/peeling, pruritus, skin discoloration and treatment-site marks/device-related pinpoint bleeding. |
| Incidence of Treatment-Emergent Adverse Events | Baseline through Day 60 | Number and proportion of participants experiencing adverse events following the radiofrequency microneedling procedure and study product application. Adverse events were assessed for severity and relationship to the device and/or topical study product. |
| Change in Investigator Facial Clinical Assessment | Baseline to Day 60 | Change from baseline in investigator-assessed facial skin characteristics, including fine wrinkling, coarse wrinkling, erythema, discoloration and overall facial appearance. Each characteristic was scored using the protocol-defined 0-9 clinical assessment scale, with higher scores indicating greater severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant-Reported Facial Skin Improvement | Through Day 60 | Participant perception of changes in facial skin was assessed using the protocol-defined questionnaire. Participants rated statements relating to skin radiance, overall appearance, hydration, skin feel, brightness, evenness of facial skin, fine lines and wrinkles, overall facial appearance, enjoyment of the products, confidence in their skin and compliments received while using the products. Responses were recorded using a 5-point Likert scale from Strongly Agree to Strongly Disagree. |
| Standardized Facial Imaging | Baseline through Day 60 | Changes in facial skin appearance were evaluated using standardized VISIA facial imaging obtained at baseline and follow-up visits. |
Countries
United States
Outcome results
None listed