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| Name | Class |
|---|---|
| Chung-Ang University Hospital | OTHER |
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The purpose of this clinical trial is to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of the investigational medical device that uses radiofrequency current when applied to the face (both cheeks), compared with the control device.
This is a prospective, single-center, comparative, randomized, evaluator-blinded, superiority, confirmatory clinical trial designed to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of an investigational medical device using radiofrequency current when applied to the face (both cheeks), compared with a control device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Device arm | Experimental | Participants will receive treatment with the investigational radiofrequency medical device (VOLNEWMER) applied to both cheeks according to the study protocol. |
|
| Control arm | Sham Comparator | Subjects assigned to this arm will receive treatment with a sham device applied to both cheeks. The sham device is identical in appearance and operation to the investigational device but does not deliver radiofrequency energy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test arm | Device | Participants receive treatment with the investigational device VOLNEWMER applied to both cheeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cutometer R7 values | Change from baseline in Cutometer R7 value at Week 12 following treatment with the investigational medical device, as assessed by an independent evaluator. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cutometer R7 values | Change from baseline in Cutometer R7 value at 8 weeks after application of the investigational medical device, as assessed by an independent evaluator. | 8 weeks |
| Percentage change from baseline in Cutometer R7 value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanyong Ghang | Contact | 82-2-2094-2116 | hy.ghang@classys.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Classys Inc | Recruiting | Seoul | 06220 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21315951 | Result | el-Domyati M, el-Ammawi TS, Medhat W, Moawad O, Brennan D, Mahoney MG, Uitto J. Radiofrequency facial rejuvenation: evidence-based effect. J Am Acad Dermatol. 2011 Mar;64(3):524-35. doi: 10.1016/j.jaad.2010.06.045. |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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pivotal medical device clinical trial
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evaluator-blinded
| Control arm | Device | Participants receive treatment using the device in training mode that does not deliver radiofrequency energy. |
|
Percent change from baseline in Cutometer R7 value at Weeks 8 and 12 after application of the investigational medical device, as assessed by an independent evaluator.
| week 8 and week 12 |
| Global Aesthetic Improvement Scale (GAIS) | Global Aesthetic Improvement Scale(GAIS) scores at Weeks 4, 8, and 12 after application of the investigational medical device, as assessed by the investigator. | 4 weeks, 8 weeks, and 12 weeks |
| Global Aesthetic Improvement Scale(GAIS) assessment | Global Aesthetic Improvement Scale(GAIS) scores assessed by participants at 4, 8, and 12 weeks following treatment with the investigational medical device. | 4, 8, and 12 weeks |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |