Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation

Skin Laxity Clinical Trial

Official title: Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation

Status Completed

Clinical Trial Summary

This study will evaluate the clinical efficacy, safety and the performance of radiofrequency heating and ultrasound delivered by the BTL-585-2 applicator of the BTL-585F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF & US) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) treatment visits and two to three follow-up visits.

Clinical Trial Description

This study will evaluate the clinical efficacy, safety and the performance of radiofrequency heating and ultrasound delivered by the BTL-585-2 applicator of the BTL-585F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF & US) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) treatment visits and two to three follow-up visits.

At the baseline visit, health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Skin hydration and elasticity in the treatment area will be measured. In addition photographs of the treated area will be taken.

The treatment administration phase in both study groups will consist of four (4) treatment visits, delivered 7 - 14 days apart. Group A will receive treatment with active ultrasound (ON) and the intensity of radiofrequency will be set to a maximum tolerable level. The group B will receive treatment with the intensity of radiofrequency set to a maximum tolerable level, but without active ultrasound (OFF).

At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-585F device.

At the last therapy visit, photographs of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in. Skin hydration and elasticity in the treatment area will be measured. ;

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

• NCT number: NCT05929625
• Study type: Interventional
• Source: BTL Industries Ltd.
• Status: Completed
• Phase: N/A
• Start date: October 28, 2020
• Completion date: May 31, 2022