NCT05524766

BTL-785F Device for Non-invasive Facial Rejuvenation in Patients Injected With Botulinum Toxin

Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Facial Rejuvenation in Patients Injected With Botulinum Toxin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the clinical safety and the efficacy of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive facial treatment in patients injected with botulinum toxin. The aim is to investigate the improvement of overall facial appearance and muscle tone.

Detailed description

This study is a single-site, open-label, interventional study. The subjects will be enrolled and assigned into two experimental study arms (active and control group). 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. The treatment administration phase (only for the active group) consists of four (4) treatment visits, delivered 5-10 days apart. Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups. Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment (the control group will not receive any treatment).

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	BTL-785-7 Treatment	Treatment with BTL-785F device (BTL-785-7 applicator) for improvement of overall facial appearance and muscle tone in patients injected with botulinum toxin.

Timeline

• Start date: 2022-07-06
• Primary completion: 2022-12-09
• Completion: 2023-02-08
• First posted: 2022-09-01
• Last updated: 2023-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study