AnteAGE Biosomes With Radiofrequency Microneedling for Facial Skin Rejuvenation

NCT07849556 | Completed

• 1 other identifier: ANTEAGE_Biosome_2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging; Facial Rhytides; Skin Tone

Keywords

Radiofrequency Microneedling; Biosome; Exosome; Facial aging

Outcome Measures

Primary Outcomes (3)

• Post-Procedure Skin Reaction Severity

  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.

  Days 1, 3, and 7 after treatment

• Incidence of Treatment-Emergent Adverse Events

  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.

  Baseline through Day 60

• Change in Investigator Facial Clinical Assessment

  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.

  Baseline to Day 60

Secondary Outcomes (2)

• Participant-Reported Facial Skin Improvement

  Through Day 60

• Standardized Facial Imaging

  Baseline through Day 60

Study Arms (2)

RF Microneedling + AnteAGE Biosomes

EXPERIMENTAL

Participants underwent facial radiofrequency microneedling with AnteAGE Biosome Treatment Solution used as the topical treatment/glide. Participants subsequently used the study-supplied active skincare regimen including AnteAGE Biosome Serum and AnteAGE Serum/Accelerator homecare.

Other: AnteAGE Biosome Treatment Solution; Device: Radiofrequency Microneedling; Other: AnteAGE Homecare Regimen

RF Microneedling + Hyaluronic Acid Control

ACTIVE COMPARATOR

Participants underwent the same facial radiofrequency microneedling procedure using hyaluronic acid as the topical glide instead of AnteAGE Biosome Treatment Solution. Participants subsequently used the study-supplied control skincare regimen.

Device: Radiofrequency Microneedling

Interventions

AnteAGE Biosome Treatment Solution OTHER

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.

RF Microneedling + AnteAGE Biosomes

Radiofrequency Microneedling DEVICE

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..

RF Microneedling + AnteAGE Biosomes; RF Microneedling + Hyaluronic Acid Control

AnteAGE Homecare Regimen OTHER

Participants used study-supplied cleanser, moisturizer, sunscreen, AnteAGE Biosome Serum, and AnteAGE Accelerator as directed during the post-treatment study period.

RF Microneedling + AnteAGE Biosomes

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cellese Inc.: lead

Study Sites (1)

YH Science & Beauty

New York, New York, 10022, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Investigator assessment of Global Aesthetic Improvement Scale outcomes was performed by two blinded investigators using standardized facial photography.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: December 3, 2024
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)