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

This study has been completed.
Sponsor:
Information provided by:
Bio-Medical Research, Ltd.
ClinicalTrials.gov Identifier:
NCT01030380
First received: December 9, 2009
Last updated: December 10, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Facial Muscle Toning
Device: Slendertone Face
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determination of the Efficacy of Slendertone® Face to Tone the Muscles of the Face and Reduce the Signs of Facial Aging

Further study details as provided by Bio-Medical Research, Ltd.:

Primary Outcome Measures:
  • Ultrasound measurements of the zygomaticus major muscle [ Time Frame: Baseline; End of Week 6; End of Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ease of Use and Overall Acceptance of the Slendertone Face device [ Time Frame: End of Week 12 ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: February 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Slendertone Face NMES
Slendertone Face 20 minutes/day, 5 days/week for 12 weeks.
Device: Slendertone Face
Slendertone Face 20 minutes/day, 5 days/week for 12 weeks.
Other Names:
  • Slendertone Face, Type 371
  • Class II, Powered Muscle Stimulator
No Intervention: Control Group: No NMES
Control Group: No NMES over the course of 12 weeks.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy (by their own report) female participants aged between 35 and 55
  • Visual signs of aging of the face
  • Able and willing to complete all study assessments and to be followed for the full course of the study.
  • Able to read, write and follow instructions in English.
  • Able and willing to provide informed consent.

Exclusion Criteria:

  • Pregnant women (or pregnancy within last 3 months).
  • Inadequate precaution or procedure to prevent pregnancy (women of child- bearing potential only).
  • Individuals who have any implanted medical devices (pacemaker, pump, catheter, etc.)
  • Current or history of a medical condition that would contraindicate treatment with the product, such as epilepsy, hernia, abdominal ulcer, diabetes, or other conditions which, in the opinion of the Investigator, would place the participant at risk.
  • A current skin disease of any type at the test site (e.g. acne, eczema, psoriasis, burns, abrasions, etc.)
  • Heavy alcohol consumption in the opinion of the investigator.
  • A fever in the last 12 hours prior to the first application of the test device.
  • History of heart disease.
  • History of stroke.
  • History of malignant disease.
  • Insulin dependent diabetes.
  • Concurrent medication likely to affect the response to the test article or confuse the results of the study (e.g. routine high dose use of any drugs that may artificially affect skin tone).
  • Individuals who are currently participating in any other clinical. investigation, or who have participated in a study with the same indication within 1 year.
  • Principal investigator for this study, or member of study staff.
  • Individuals who have had facial surgery.
  • Individuals who use BOTOX. (The latter two exclusions were applied because of the possibility of an altered anatomical or physiological background which may have interfered with the effectiveness of the treatment).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030380

Locations
Ireland
Bio-Medical Research, Ltd.
Galway, County Galway, Ireland
Sponsors and Collaborators
Bio-Medical Research, Ltd.
Investigators
Principal Investigator: Michael Hennessy, M.D. Chief of Neurology, Galway University Hospital
  More Information

Publications:
Porcari, JP, Miller, J., Cornwell, K. et al. The effects of neuromuscular electrical stimulation training on abdominal strength, endurance and selected anthropometric measures. Journal of Sports Science and Medicine. 2005;4(1):66 - 75.

Responsible Party: Dr. Michael Hennessy, Principal Investigator, Neurologist
ClinicalTrials.gov Identifier: NCT01030380     History of Changes
Other Study ID Numbers: BMR-09-2009
Study First Received: December 9, 2009
Last Updated: December 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Bio-Medical Research, Ltd.:
Facial toning
Facial lift
Improve facial complexion
Improve facial tone
Improve radiance of the face
Reduce signs of facial aging
firming, lift, tone face

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014