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Evaluation of a Bimodal-approach Radiofrequency Device for Lower Facial Tightening: Open Labelled Control Study

Evaluation of a Bimodal-approach Radiofrequency Device for Lower Facial Tightening: Open Labelled Control Study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250924004
Enrollment
26
Registered
2025-09-24
Start date
2025-02-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

participants aged 25 to 60 years with mild to moderate skin laxity. Facial laxity, Facial tightening, Nasolabial fold, Bimodal, Radiofrequency

Interventions

Single session of RF treatment applied bilaterally to the cheeks and jawline with energy titrated according to individual pain tolerance Likert pain score four to five out of ten.
Experimental Procedure/Surgery
Density RF

Sponsors

Natcha Chottawornsak
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Males and females aged 25-60 years 2. Mild to moderate skin laxity.

Exclusion criteria

Exclusion criteria: 1.Presence of a cardiac pacemaker., 2.Body mass index (BMI) greater than 25 3.History of hypertrophic scars or keloids. 4.Active systemic or cutaneous infections. 5.Open wounds at the intended treatment site. 6.Immunodeficiency disorders. 7.Underlying connective tissue diseases. 8.History of prior radiation therapy. 9.Pregnancy. 10.Breastfeeding. 11.Receipt of radiofrequency, high-frequency ultrasound, botulinum toxin injection, or laser skin-tightening procedures within 6 months prior to enrollment. 12.Receipt of dermal filler injections within 12 months prior to enrollment. 13.Current tobacco use.

Design outcomes

Primary

MeasureTime frame
Investigators global assessment for Lower Facial laxity improvement month 0,1,3,6 6-point improvement scale

Secondary

MeasureTime frame
Midface and lower Facial Laxity month 0,1,3,6 Facial Laxity rating scale,Participant and investigator satisfaction month 0,1,3,6 4-point Likert scale,Nasolabial fold overall size (cross section) ,width and depth month 0,1,3,6 Antera 3D,skin texture parameter month 0,1,3,6 Visia,Brown spot month 0,1,3,6 Visia

Countries

Thailand

Contacts

Public ContactNatcha Chottawornsak

Faculty of Medicine, Chulalongkorn university

natchaaa.c@gmail.com0844495142

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026