NCT07261527尚未招募不适用
Characterization of Skin and Facial Fat Pad Thickness Changes Following Microneedling Radiofrequency With and Without Topical Poly-L-Lactic Acid for Facial Rejuvenation
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月24日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging
研究概览
简要总结
The purpose of this study is to evaluate whether microneedling RF subcutaneous fat pad thickness in the temple, submental, and cheek regions, to determine whether the addition of topical PLLA after microneedling RF alters or preserves subcutaneous fat pad thickness and to assess patient satisfaction and perceived outcomes following microneedling RF ± PLLA treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Seeking facial rejuvenation for cosmetic concerns
- •Able and willing to provide informed consent
- •Willing to comply with study procedures and follow-up visits
排除标准
- •Prior filler injection or energy-based device treatment to the face within the past 6 months
- •Previous facial surgeries
- •Pregnant or breastfeeding
- •Active infection, dermatitis, or open lesions in the treatment area
- •History of keloids or abnormal scarring
- •Known allergy to poly-L-lactic acid (PLLA)- Current participation in another clinical trial involving facial aesthetic treatments
- •Presence of pre-cancerous or cancerous lesions in the treatment area
- •Current or planned use of glucagon-like peptide-1 receptor agonists (e.g., Ozempic, semaglutide) during the study period. Subjects on these medications will be excluded due to potential effects on facial fat and overall weight.
- •HIV+ patients
- •Patients on HIV medications- Patients that have eczema and rosacea
研究组 & 干预措施
microneedling radiofrequency (RF)
Experimental
干预措施: microneedling RF treatment (Device)
microneedling RF treatment with topical poly-L-lactic acid (PLLA)
Experimental
干预措施: microneedling RF treatment (Device)
microneedling RF treatment with topical poly-L-lactic acid (PLLA)
Experimental
干预措施: PLLA (Device)
microneedling RF treatment with placebo
Experimental
干预措施: microneedling RF treatment (Device)
microneedling RF treatment with placebo
Experimental
干预措施: Sterile Water as control (Drug)
结局指标
主要结局
Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging
时间窗: Baseline, 6 months
次要结局
- Difference in fat pad thickness between the RF+PLLA side and RF-only side as assessed by ultrasound imaging(6 months)
- Patient reported overall improvement in appearance as assessed by the Global Aesthetic Scale(6 months)
- Change in satisfaction with forehead as assessed by the patient questionnaire(Baseline, 6 months)
- Change in satisfaction with cheek as assessed by the patient questionnaire(Baseline, 6 months)
- Change in satisfaction with submental as assessed by the patient questionnaire(Baseline, 6 months)
- Change in overall social confidence as assessed by the patient questionnaire(Baseline, 6 months)
研究者
Ying Chen
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Sylfirm X Radiofrequency Microneedling for the Treatment of MelasmaMelasmaNCT06415435Benev Company, Inc.90
已完成
不适用
Effects of Capacitive Radiofrequency at the Dermis and Adipose TissueAdiposityAbdominal ObesityNCT04182542Escola Superior de Tecnologia da Saúde do Porto20
已完成
不适用
Usefulness of Non-invasive Radiofrequency Therapy for Facial ContouringSubcutaneous FatNCT02512822Kangbuk Samsung Hospital21
已完成
不适用
Prospective Pellevé™ Neck Wrinkle StudyFacial and Neck RhytidesNCT01299090Ellman International49
已完成
不适用
RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of CelluliteCellulitis of LegNCT06283056InMode MD Ltd.48