Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of the Facial Wrinkles, a Prospective, Multicenter, Evaluator Blinded, Randomized, Parallel-controlled, Non-inferior Clinical Trial

The goal of this clinical trial is to evaluate the safety and efficacy of the monopolar radiofrequency therapy device developed by CLASSYS Inc. for improving facial and periorbital wrinkles. This is a prospective, multicenter, evaluator-blinded, randomized, parallel-controlled, non-inferiority clinical trial.
The main questions the study aims to answer are:
Does the monopolar radiofrequency device improve the appearance of facial and periorbital wrinkles? Is the safety profile of the monopolar radiofrequency device acceptable?
Researchers will compare the investigational device to the Thermage CPT System (Solta Medical Co., Ltd.) to see if the monopolar radiofrequency device is non-inferior in terms of wrinkle improvement.
Participants will:
Undergo a single treatment session with either the investigational device or the control device.
Be followed up for a period of 3 months to assess wrinkle improvement and safety outcomes.
The primary outcome will be the improvement in facial and periorbital wrinkles, measured by the Facial Wrinkle and Elasticity Scale (FWES), 3 months post-treatment. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS) and a Visual Analog Scale (VAS) for pain. Safety evaluations will include adverse event (AE) and serious adverse event (SAE) monitoring.

Start Date29 Sep 2024

Sponsor / Collaborator

CLASSYS, Inc.

100 Clinical Results associated with CLASSYS, Inc.

0 Patents (Medical) associated with CLASSYS, Inc.

Literatures (Medical) associated with CLASSYS, Inc.

31 Dec 2024·Journal of Dermatological Treatment

Noninvasive high-intensity focused ultrasound for skin brightening efficacy using a topical agent containing glutathione and hyaluronic acid

Article

Author: Peng, Hsien Li Peter ; Lee, Angela Wai Kay ; Lu, Sophie Pei-Hsuan ; Yi, Kyu-Ho ; Huang, Po Han Patrick ; Kim, Eunjae ; Yang, Yu-Chieh ; Wan, Jovian ; Huang, Jeff

BACKGROUNDHigh-intensity focused ultrasound (HIFU) is well-documented for skin rejuvenation, lifting, and tightening. However, its synergistic effects with topical agents, enhanced by HIFU-induced vibration and heat, remain underexplored.OBJECTIVETo evaluate clinical and photographic outcomes of HIFU combined with a topical agent versus the topical agent alone.METHODThis non-randomized controlled trial involved 20 female volunteers (ages 30-55) divided into two groups. Group A (n = 10) received two HIFU sessions combined with a topical agent containing glutathione and hyaluronic acid. Group B (n = 10) received the topical agent alone. Outcomes were assessed using digital photography, patient satisfaction surveys, and the A-One Smart^™ system for fine wrinkles, hyperpigmentation, and hydration. Skin brightening was evaluated with the Global Esthetic Improvement Scale (GAIS).RESULTSGroup A showed significant reductions in fine wrinkles (6.25 ± 2.00 mm to 3.10 ± 1.62 mm), improved hyperpigmentation (3.50 ± 0.80 to 2.10 ± 1.05), and increased hydration (28 ± 10 to 55 ± 11) (all p < 0.05). Over two-thirds of Group A reported significant improvements, with no complications. Group B showed minimal, non-significant changes (p > 0.05), with only 30% reporting noticeable improvements.CONCLUSIONCombining HIFU with a topical agent significantly enhances skin quality and brightness without adverse effects.

01 Sep 2022·Dermatologic Therapy

Cryolipolysis for abdominal subcutaneous fat reduction: A prospective, multicenter, single arm, clinical study

Article

Author: Seok, Joon ; Ko, Joo Yeon ; Yoo, Kwang Ho ; Choi, Sun Young ; Park, Jae Wan ; Jue, Mihn Sook ; Kim, Soo Yeon ; Jung, You Jin ; Ko, Eun Jung ; Koh, Young Gue ; Kim, Beom Joon ; Huh, Yun Jung

Various treatment methods are used for noninvasive body contouring. To evaluate the efficacy and safety of a newly designed cryolipolysis device using a three-dimensional cooling method for abdominal fat reduction. Twenty-five participants with clinically apparent abdominal fat tissue participated in the study. The thickness of fat tissue below the umbilicus level was measured using a caliper at baseline and 12 weeks after the first treatment. The height of abdominal subcutaneous fat tissue on ultrasonography and participant satisfaction were assessed at every visit for 16 weeks. All adverse events (AEs) during the study period were recorded. p values <0.05 were considered statistically significant. Twenty-four participants completed this study; the mean BMI of participants was 29.34 ± 2.36 kg/m² . The mean thickness of abdominal subcutaneous fat was significantly lower at 12 weeks (40.4 ± 6.8 mm, p < 0.001) than at baseline (49.3 ± 8.5 mm). Differences in the height of abdominal subcutaneous fat compared to that at baseline were 1.02 ± 0.41 cm (12 weeks, p < 0.001) and 1.13 ± 0.44 cm (16 weeks, p < 0.001). Rates of abdominal subcutaneous fat reduction at 12 and 16 weeks compared to that at baseline were 28.45% and 31.13%, respectively. The ratio of abdominal circumference to hip circumference at 12 and 16 weeks was significantly decreased compared to that at baseline. Most participants (95.8%) reported improvement in satisfaction scores at 16 weeks. There were no serious AEs during the entire study period. The study demonstrated the efficacy of a noninvasive cryolipolysis device using a three-dimensional cooling method for reducing abdominal subcutaneous fat.

01 Jan 2022·Annals of Dermatology

Efficacy and Safety of Cold-Induced Noninvasive Targeted Fat Reduction in Pseudogynecomastia

Article

Author: Park, Su Jung ; Kim, Soo Yeon ; Kim, Beom Joon ; Hong, Ji Yeon

BACKGROUNDTreatment options for pseudogynecomastia are limited, and the demand for noninvasive breast fat reduction is increasing.OBJECTIVEWe evaluated the efficacy and safety of a cold-induced lipolysis device for treating pseudogynecomastia.METHODSIn this 16-week prospective trial, a total of 15 male patients with pseudogynecomastia were treated twice with cryolipolysis. The primary endpoint was a change in the chest circumference from baseline at posttreatment week 8. Secondary endpoints were changes in body weight, fat thickness assessed using ultrasonography, independent evaluator- and patient-rated improvement, and Simon's gynecomastia class (SGC) grading.RESULTSThe primary assessment, a reduction of 3.05 cm in the mean chest circumference at 8 weeks post-treatment compared to baseline, was statistically significant. The treatment effect was cumulative, with a steady decrease in chest circumference and fat thickness over the 16-week study period. The mean pain score immediately after the first session of treatment was 2.0±1.36, based on a scale of 0~10, with a score of 10 being the worst pain ever experienced. The pain decreased substantially after the end of the procedure.CONCLUSIONCryolipolysis was demonstrated to be an effective and safe option for reducing breast fat in pseudogynecomastia. Male with mild to moderate breast enlargement without skin excess can be ideal candidates.

100 Deals associated with CLASSYS, Inc.

100 Translational Medicine associated with CLASSYS, Inc.

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