Clinical trial NCT01030380: Determination of the Efficacy of Slendertone® Face to Tone the Muscles of the Face and Reduce the Signs of Facial Aging
Official title: Determination of the Efficacy of Slendertone® Face to Tone the Muscles of the Face and Reduce the Signs of Facial Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Facial Muscle Toning
Keywords: Facial toning
Facial lift
Improve facial complexion
Improve facial tone
Improve radiance of the face
Reduce signs of facial aging
firming, lift, tone face
Lead sponsor: Bio-Medical Research, Ltd.
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 108
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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).

Primary outcomes:
measure: Ultrasound measurements of the zygomaticus major muscle
timeFrame: Baseline; End of Week 6; End of Week 12
measure: Increased psychometric assessments of improvements among the characteristics of facial appearance: firming; tone; lift; radiance and complexion
timeFrame: Baseline; End of Week 6 and End of Week 12
Secondary outcomes:
measure: Ease of Use and Overall Acceptance of the Slendertone Face device
timeFrame: End of Week 12
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Bio-Medical Research, Ltd.
state: County Galway
Study officials:
affiliation: Chief of Neurology, Galway University Hospital
name: Michael Hennessy, M.D.
role: PRINCIPAL_INVESTIGATOR
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