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

December 10, 2009 updated by: Bio-Medical Research, Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • County Galway
      • Galway, County Galway, Ireland
        • Bio-Medical Research, Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ultrasound measurements of the zygomaticus major muscle
Time Frame: Baseline; End of Week 6; End of Week 12
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
Baseline; End of Week 6 and End of Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Ease of Use and Overall Acceptance of the Slendertone Face device
Time Frame: End of Week 12
End of Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio-Medical Research, Ltd.

Investigators

  • Principal Investigator: Michael Hennessy, M.D., Chief of Neurology, Galway University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 11, 2009

Study Record Updates

Last Update Posted (Estimate)

December 11, 2009

Last Update Submitted That Met QC Criteria

December 10, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMR-09-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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