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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01030380
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : December 11, 2009
Information provided by:
Bio-Medical Research, Ltd.

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.

Condition or disease Intervention/treatment Phase
Facial Muscle Toning Device: Slendertone Face Phase 3

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.


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : February 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Ultrasound measurements of the zygomaticus major muscle [ Time Frame: Baseline; End of Week 6; End of Week 12 ]
  2. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01030380

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


Responsible Party: Dr. Michael Hennessy, Principal Investigator, Neurologist Identifier: NCT01030380     History of Changes
Other Study ID Numbers: BMR-09-2009
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: December 2009

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:
Disease Attributes
Pathologic Processes