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

B

Bio-Medical Research Limited

Status and phase

Completed
Phase 3

Conditions

Facial Muscle Toning

Treatments

Device: Slendertone Face

Study type

Interventional

Funder types

Industry

Identifiers

NCT01030380
BMR-09-2009

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 patients

Sex

Female

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

108 participants in 2 patient groups

Slendertone Face NMES
Experimental group
Description:
Slendertone Face 20 minutes/day, 5 days/week for 12 weeks.
Treatment:
Device: Slendertone Face
Control Group: No NMES
No Intervention group
Description:
Control Group: No NMES over the course of 12 weeks.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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