Last reviewed · How we verify
NCT06816069
Study on Safety and Efficacy of Monopolar Radio Frequency Device for Facial Skin Tightening
NA trial testing VOLNEWMER in Skin Aging in 36 participants. Participants enrolled and being followed up; not accepting new ones.
1 March 2025
Quick facts
| Lead sponsor | CLASSYS Inc. |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 10 November 2024 |
| Primary completion | 1 March 2025 |
| Estimated completion | 1 March 2025 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- VOLNEWMER
Conditions studied
- Skin Aging — all drugs for Skin Aging →
Sponsor
CLASSYS Inc. — full company profile →
Who can join
Adults 19 to 65, any sex, with Skin Aging. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Objective: The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial. Research Questions: 1. Does the VOLNEWMER device improve skin elasticity? 2. Is the safety profile of the VOLNEWMER device acceptable? Subject Procedures: Subjects will: * Receive a single treatment session using the VOLNEWMER device. * Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety. The primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06816069
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Skin Aging
Currently open trials in the same condition.
- NCT07381218 — Focused Ultrasound Treatment for Facial Skin Laxity · NA · active not recruiting
- NCT06900660 — Evaluation of the Skin-Beautifying Effects of Collagen Drinks · NA · active not recruiting
- NCT06804772 — A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α in Subjects, Aged 35-65 Years of Age, to Improve the · NA · active not recruiting
- NCT06727292 — Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo · NA · recruiting
- NCT07145905 — TCRM for Correction of Cheek Including Fine Lines · NA · active not recruiting
Other CLASSYS Inc. trials
Trials by the same sponsor.
- NCT07471399 — Safety and Efficacy Assessment for the Temporary Facial Skin Tightening Improvement Effect Using the Monopolar Radiofreq · NA · recruiting
- NCT07229430 — Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck T · NA · recruiting
- NCT06724510 — Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting · NA · recruiting
- NCT06657365 — Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06816069 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CLASSYS Inc.
- Last refreshed: 18 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06816069.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing