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

Last updated: December 10, 2009
Sponsor: Bio-Medical Research, Ltd.
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01030380
BMR-09-2009
  • Ages 25-55
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 fullcourse of the study.

  • Able to read, write and follow instructions in English.

  • Able and willing to provide informed consent.

Exclusion

Exclusion Criteria:

  • Pregnant women (or pregnancy within last 3 months).

  • Inadequate precaution or procedure to prevent pregnancy (women of child- bearingpotential only).

  • Individuals who have any implanted medical devices (pacemaker, pump, catheter, etc.)

  • Current or history of a medical condition that would contraindicate treatment with theproduct, such as epilepsy, hernia, abdominal ulcer, diabetes, or other conditionswhich, 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 theresults of the study (e.g. routine high dose use of any drugs that may artificiallyaffect skin tone).

  • Individuals who are currently participating in any other clinical. investigation, orwho 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 thepossibility of an altered anatomical or physiological background which may haveinterfered with the effectiveness of the treatment).

Study Design

Total Participants: 108
Study Start date:
February 01, 2009
Estimated Completion Date:
May 31, 2009

Study 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.

Connect with a study center

  • Bio-Medical Research, Ltd.

    Galway, County Galway
    Ireland

    Site Not Available

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