NCT01740440

Effect of a Transcutaneous Electrical Nerve Stimulation (TENS) Device on Overall Facial Appearance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bio-Medical Research, Ltd. · Industry
• Sex: Female
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Safety and clinical performance of the BMR Face device (manufactured by Bio-Medical Research)

Detailed description

Evaluate the efficacy of the BMR Face device in relation to facial appearance at 12 weeks compared to baseline. Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement Secondary objectives are to evaluate safety and further evaluate the subject's and investigator's satisfaction (both a live and blinded assessor) with the BMR Face treatment.

Conditions

• Ageing

Interventions

Type	Name	Description
DEVICE	BMR Face	BMR Face used in accordance with manufacturer IFU

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-12-04
• Last updated: 2016-06-30
• Results posted: 2016-03-24

Locations

1 site across 1 country: United States