Abstract：
BACKGROUND: A firming and toning cosmetic body lotion (FTB) was developed to target key pathways relevant to body skin health and rejuvenation that may complement the improvements observed after noninvasive body contouring (NIBC). A pilot study explored the efficacy and tolerability of FTB as an adjunct to cryolipolysis.
METHODS: An open-label, single-site, single-arm, 12-week study enrolled subjects aged 20 to 65 who had pre-elected to receive 1 or more cryolipolysis treatments (CoolSculpting® or CoolSculpting® Elite; Zeltiq Aesthetics, Inc.) on the inner thigh, back/bra fat, or submental areas. Immediately post-procedure, the investigator applied FTB to the treated area. Subjects then applied FTB topically twice daily for 12 weeks on the treated area. Skin texture and firmness were graded visually by the investigator using a 10-point scale, and subjects graded effectiveness, product attributes, and satisfaction with a questionnaire. Results: Seventeen subjects (16 women, 1 man) enrolled. After 12 weeks of FTB application, significant improvements in skin firmness were observed in all treated areas, while skin texture showed improvements on the inner thigh and back/bra fat (all P≤0.009). With continued use following cryolipolysis, more than 70% of subjects agreed that FTB improved skin firmness, smoothness, and overall appearance. Subjects indicated that FTB was an effective adjunct to cryolipolysis. Throughout the study, 86% to 92% of subjects reported “fair,” “good,” or “excellent” satisfaction with FTB. Conclusion: This pilot study suggests that FTB may complement skin improvements seen post-NIBC.J Drugs Dermatol. 2024;23(4): doi:10.36849/JDD.7917.
METHODS: An open-label, single-site, single-arm, 12-week study enrolled subjects aged 20 to 65 who had pre-elected to receive 1 or more cryolipolysis treatments (CoolSculpting® or CoolSculpting® Elite; Zeltiq Aesthetics, Inc.) on the inner thigh, back/bra fat, or submental areas. Immediately post-procedure, the investigator applied FTB to the treated area. Subjects then applied FTB topically twice daily for 12 weeks on the treated area. Skin texture and firmness were graded visually by the investigator using a 10-point scale, and subjects graded effectiveness, product attributes, and satisfaction with a questionnaire. Results: Seventeen subjects (16 women, 1 man) enrolled. After 12 weeks of FTB application, significant improvements in skin firmness were observed in all treated areas, while skin texture showed improvements on the inner thigh and back/bra fat (all P≤0.009). With continued use following cryolipolysis, more than 70% of subjects agreed that FTB improved skin firmness, smoothness, and overall appearance. Subjects indicated that FTB was an effective adjunct to cryolipolysis. Throughout the study, 86% to 92% of subjects reported “fair,” “good,” or “excellent” satisfaction with FTB. Conclusion: This pilot study suggests that FTB may complement skin improvements seen post-NIBC.J Drugs Dermatol. 2024;23(4): doi:10.36849/JDD.7917.
摘要：
背景：开发了一种紧致和调理美容身体乳液（FTB），以靶向与身体皮肤健康和恢复活力相关的关键途径，可以补充非侵入性身体轮廓（NIBC）后观察到的改善。一项初步研究探索了FTB作为冷冻脂解的辅助手段的功效和耐受性。
方法：开放标签，单站点,单臂,为期12周的研究招募了年龄在20至65岁之间的受试者，他们预先选择接受1种或多种冷冻溶聚治疗（CoolSculpting＆reg;或CoolSculpting＆reg;Elite;Zeltiq美学，Inc.）在大腿内侧，背部/胸罩脂肪，或下区。手术后立即，研究者将FTB应用于治疗区域。然后受试者在治疗区域上每天两次局部施用FTB,持续12周。皮肤质地和紧实度由研究者使用10点量表进行视觉分级，受试者对有效性进行分级，产品属性，以及对问卷的满意度。结果：17名受试者（16名女性，1人）注册。FTB应用12周后，在所有治疗区域观察到皮肤紧致度的显著改善，而大腿内侧和背部/胸罩脂肪的皮肤纹理显示出改善（所有P＆le;0.009）。随着冷冻脂解后的继续使用，超过70％的受试者同意FTB改善皮肤紧致度，平滑度,和整体外观。受试者表明FTB是冷冻脂解的有效辅助手段。在整个研究过程中,86%至92%的受试者报告了“公平，”“好,”或“优秀”对FTB的满意度。结论：这项初步研究表明，FTB可以补充NIBC后的皮肤改善。J药物Dermatol.2024；23（4）：doi：10.36849/JD.7917。
方法：开放标签，单站点,单臂,为期12周的研究招募了年龄在20至65岁之间的受试者，他们预先选择接受1种或多种冷冻溶聚治疗（CoolSculpting＆reg;或CoolSculpting＆reg;Elite;Zeltiq美学，Inc.）在大腿内侧，背部/胸罩脂肪，或下区。手术后立即，研究者将FTB应用于治疗区域。然后受试者在治疗区域上每天两次局部施用FTB,持续12周。皮肤质地和紧实度由研究者使用10点量表进行视觉分级，受试者对有效性进行分级，产品属性，以及对问卷的满意度。结果：17名受试者（16名女性，1人）注册。FTB应用12周后，在所有治疗区域观察到皮肤紧致度的显著改善，而大腿内侧和背部/胸罩脂肪的皮肤纹理显示出改善（所有P＆le;0.009）。随着冷冻脂解后的继续使用，超过70％的受试者同意FTB改善皮肤紧致度，平滑度,和整体外观。受试者表明FTB是冷冻脂解的有效辅助手段。在整个研究过程中,86%至92%的受试者报告了“公平，”“好,”或“优秀”对FTB的满意度。结论：这项初步研究表明，FTB可以补充NIBC后的皮肤改善。J药物Dermatol.2024；23（4）：doi：10.36849/JD.7917。
