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COMPLETED

NCT07849556

AnteAGE Biosomes With Radiofrequency Microneedling for Facial Skin Rejuvenation

Sponsor: Cellese Inc.

View on ClinicalTrials.gov

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.

Official title: Clinical Evaluation of the Efficacy and Tolerability of AnteAGE Biosomes and Facial Radiofrequency Microneedling

Key Details

Gender

All

Age Range

30 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-03

Completion Date

2025-06-18

Last Updated

2026-09-30

Healthy Volunteers

Yes

Conditions

Skin Aging Facial Rhytides Skin Tone

Interventions

OTHER

AnteAGE 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.

DEVICE

Radiofrequency Microneedling

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..

OTHER

AnteAGE Homecare Regimen

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

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.

Locations (1)

YH Science & Beauty

New York, New York, United States