Clinical Trial: Determination of the Efficacy of Slendertone® Face to Tone the Muscles of the Face and Reduce the Signs of Facial Aging

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Determination of the Efficacy of Slendertone® Face to Tone the Muscles of the Face and Reduce the Signs of Facial

Brief Summary: The purpose of this study was to determine the efficacy of Slendertone® Face™, to tone the muscles of the face and reduce the signs of facial aging among the following characteristics: radiance, tone, lift, firmness and complexion, following a 12-week programme of facial muscle toning. Slendertone® Face is a neuromuscular electrical stimulation (NMES) device which features a headset unit designed for application to the face for facial toning. The purpose of the headset is to locate and support a pair of stimulation electrodes on each side of the face, over the facial nerve just anterior to the ear.

Detailed Summary:

The trial was planned with 100 healthy female volunteers between 25 and 55 years of age.

Treated group: Face device 20 minutes per day, 5 days per week for 12 weeks.

Control group: No NMES.

Both Groups: No changes to usual beauty routine, or use of beauty products with an anti-aging claim, or changes to usual diet or exercise habits over the course of the 12 week study period.

Assessments:

Ultrasound measurements of the zygomaticus major muscle were planned at Baseline, and at the end of Weeks 6 and 12.

Psychometric questionnaires at Baseline, end of Weeks 6 and 12.


Sponsor: Bio-Medical Research, Ltd.

Current Primary Outcome:

  • Ultrasound measurements of the zygomaticus major muscle [ Time Frame: Baseline; End of Week 6; End of Week 12 ]
  • Increased psychometric assessments of improvements among the characteristics of facial appearance: firming; tone; lift; radiance and complexion [ Time Frame: Baseline; End of Week 6 and End of Week 12 ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Ease of Use and Overall Acceptance of the Slendertone Face device [ Time Frame: End of Week 12 ]

Original Secondary Outcome: Same as current

Information By: Bio-Medical Research, Ltd.

Dates:
Date Received: December 9, 2009
Date Started: February 2009
Date Completion:
Last Updated: December 10, 2009
Last Verified: December 2009