Facial Muscle Toning Clinical Trial
— FaceOfficial title:
Determination of the Efficacy of Slendertone® Face to Tone the Muscles of the Face and Reduce the Signs of Facial Aging
| Verified date | December 2009 |
| Source | Bio-Medical Research, Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 108 |
| Est. completion date | May 2009 |
| Est. primary completion date | May 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 25 Years to 55 Years |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Ireland | Bio-Medical Research, Ltd. | Galway | County Galway |
| Lead Sponsor | Collaborator |
|---|---|
| Bio-Medical Research, Ltd. |
Ireland,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ultrasound measurements of the zygomaticus major muscle | Baseline; End of Week 6; End of Week 12 | No | |
| Primary | Increased psychometric assessments of improvements among the characteristics of facial appearance: firming; tone; lift; radiance and complexion | Baseline; End of Week 6 and End of Week 12 | No | |
| Secondary | Ease of Use and Overall Acceptance of the Slendertone Face device | End of Week 12 | No |