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AnteAGE Biosomes With Radiofrequency Microneedling for Facial Skin Rejuvenation

2026年9月24日 更新者：Cellese Inc.

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

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • New York
      • New York、New York、美国、10022
        • YH Science & Beauty

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：RF Microneedling + AnteAGE Biosomes

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.
其他：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.

设备：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..

其他：AnteAGE Homecare Regimen

Participants used study-supplied cleanser, moisturizer, sunscreen, AnteAGE Biosome Serum, and AnteAGE Accelerator as directed during the post-treatment study period.
有源比较器：RF Microneedling + Hyaluronic Acid Control

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.
设备：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..

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Post-Procedure Skin Reaction Severity
大体时间：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.
Days 1, 3, and 7 after treatment
Incidence of Treatment-Emergent Adverse Events
大体时间：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.
Baseline through Day 60
Change in Investigator Facial Clinical Assessment
大体时间：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.
Baseline to Day 60

次要结果测量

结果测量
措施说明
大体时间
Participant-Reported Facial Skin Improvement
大体时间：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.
Through Day 60
Standardized Facial Imaging
大体时间：Baseline through Day 60

Changes in facial skin appearance were evaluated using standardized VISIA facial imaging obtained at baseline and follow-up visits.
Baseline through Day 60

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Cellese Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年12月3日

初级完成 (实际的)

2025年6月18日

研究完成 (实际的)

2025年6月18日

研究注册日期

首次提交

2026年9月24日

首先提交符合 QC 标准的

2026年9月24日

首次发布 (实际的)

2026年9月30日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • ANTEAGE_Biosome_2024

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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