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NCT03534609
Lutronic Genius System for Neck Treatment
NA trial testing Lutronic Genius System in Wrinkle in 18 participants. Completed in 10 January 2020.
16 January 2019
Quick facts
| Lead sponsor | CynosureLutronic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 27 March 2018 |
| Primary completion | 16 January 2019 |
| Estimated completion | 10 January 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lutronic Genius System
Conditions studied
- Wrinkle — all drugs for Wrinkle →
- Skin Laxity — all drugs for Skin Laxity →
- Skin Texture Disorder — all drugs for Skin Texture Disorder →
Sponsor
CynosureLutronic — full company profile →
Who can join
18 and older, any sex, with Wrinkle or Skin Laxity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Genius system is substantially equivalent to the Infini device (K121481). The study is a prospective, multi-site, non-randomized study of up to 30 treated subjects presenting for treatment of mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03534609
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06385171 — Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation · recruiting
- NCT06557434 — AV-23-001 AVAVA MIRIA Pilot Study · NA · active not recruiting
- NCT06202274 — Clinical Study to Evaluate the Safety and Efficacy of Candela Technology · NA · active not recruiting
Other CynosureLutronic trials
Trials by the same sponsor.
- NCT06117293 — Safety and Efficacy Evaluation of the Mosaic Ultra Device · NA · unknown
- NCT06152900 — Safety and Efficacy of Electronic Stimulation for Circumferential Reduction and Muscle Toning · NA · completed
- NCT04207047 — Histologic Evaluation of Tissue Following Lutronic System Exposure · NA · unknown
- NCT04208100 — Pilot Evaluation of the Lutronic PicoPlus System for the Treatment of Benign Pigmented Lesions of the Hands · NA · active not recruiting
- NCT03456674 — LaseMD System for the Treatment of Melasma · NA · active not recruiting
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 NCT03534609 (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 CynosureLutronic
- Last refreshed: 13 January 2020
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/NCT03534609.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing