Facial Muscle ToningPhase 3FaceNCT01030380

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

A Phase 3 study testing Slendertone Face in people with Facial Muscle Toning, run by Bio-Medical Research, Ltd. at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Facial Muscle Toning
What is being tested?: Slendertone Face
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteIreland
Study dates: Feb 2009to May 2009
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 16Show fewer

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 locations and contacts

1 site in 1 country.

Ireland1 site

Bio-Medical Research, Ltd.
Galway, County Galway

Other trials in Ireland

About this study

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.

Read the 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.

Conditions: Facial Muscle Toning
Being tested: Slendertone Face
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Slendertone FaceDevice
Also called Slendertone Face, Type 371, Class II, Powered Muscle Stimulator
Slendertone Face 20 minutes/day, 5 days/week for 12 weeks.

Study groups in NCT01030380
Study group	Role	What they receive
Slendertone Face NMES	Experimental	Slendertone Face 20 minutes/day, 5 days/week for 12 weeks. Receives: Device: Slendertone Face
Control Group: No NMES	No intervention	Control Group: No NMES over the course of 12 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

Ultrasound measurements of the zygomaticus major muscle
Measured: 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
Measured: Baseline; End of Week 6 and End of Week 12

Secondary outcomes (1)

Ease of Use and Overall Acceptance of the Slendertone Face device
Measured: End of Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009May 2009

First posted11 Dec 2009 (estimated)
Study startFeb 2009
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Facial Muscle ToningStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01030380
Sponsor's protocol ID: BMR-09-2009
Acronym: Face
Status last verified: Dec 2009
First submitted: 9 Dec 2009
Last updated: 11 Dec 2009
Results posted: No
Data monitoring committee: No

Publications

Coleman SR, Grover R. The anatomy of the aging face: volume loss and changes in 3-dimensional topography. Aesthet Surg J. 2006 Jan-Feb;26(1S):S4-9. doi: 10.1016/j.asj.2005.09.012.
PubMed 19338976
Rexbye H, Petersen I, Johansens M, Klitkou L, Jeune B, Christensen K. Influence of environmental factors on facial ageing. Age Ageing. 2006 Mar;35(2):110-5. doi: 10.1093/ageing/afj031. Epub 2006 Jan 11.
PubMed 16407433
Roubenoff R. Sarcopenia and its implications for the elderly. Eur J Clin Nutr. 2000 Jun;54 Suppl 3:S40-7. doi: 10.1038/sj.ejcn.1601024.
PubMed 11041074
Branchet MC, Boisnic S, Frances C, Robert AM. Skin thickness changes in normal aging skin. Gerontology. 1990;36(1):28-35. doi: 10.1159/000213172.
PubMed 2384222
Zimbler MS, Kokoska MS, Thomas JR. Anatomy and pathophysiology of facial aging. Facial Plast Surg Clin North Am. 2001 May;9(2):179-87, vii.
PubMed 11457684
McMiken DF, Todd-Smith M, Thompson C. Strengthening of human quadriceps muscles by cutaneous electrical stimulation. Scand J Rehabil Med. 1983;15(1):25-8.
PubMed 6828830
Charette SL, McEvoy L, Pyka G, Snow-Harter C, Guido D, Wiswell RA, Marcus R. Muscle hypertrophy response to resistance training in older women. J Appl Physiol (1985). 1991 May;70(5):1912-6. doi: 10.1152/jappl.1991.70.5.1912.
PubMed 1864770
Bax L, Staes F, Verhagen A. Does neuromuscular electrical stimulation strengthen the quadriceps femoris? A systematic review of randomised controlled trials. Sports Med. 2005;35(3):191-212. doi: 10.2165/00007256-200535030-00002.
PubMed 15730336
Porcari JP, Miller J, Cornwell K, Foster C, Gibson M, McLean K, Kernozek T. The effects of neuromuscular electrical stimulation training on abdominal strength, endurance, and selected anthropometric measures. J Sports Sci Med. 2005 Mar 1;4(1):66-75. eCollection 2005 Mar 1.
PubMed 24431963
Quittan M, Wiesinger GF, Sturm B, Puig S, Mayr W, Sochor A, Paternostro T, Resch KL, Pacher R, Fialka-Moser V. Improvement of thigh muscles by neuromuscular electrical stimulation in patients with refractory heart failure: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2001 Mar;80(3):206-14; quiz 215-6, 224. doi: 10.1097/00002060-200103000-00011.
PubMed 11237275
Vanderthommen M, Depresseux JC, Dauchat L, Degueldre C, Croisier JL, Crielaard JM. Spatial distribution of blood flow in electrically stimulated human muscle: a positron emission tomography study. Muscle Nerve. 2000 Apr;23(4):482-9. doi: 10.1002/(sici)1097-4598(200004)23:43.0.co;2-i.
PubMed 10716757

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determination of the Efficacy of Slendertone® Face to Tone the Muscles of the Face and Reduce the Signs of Facial Aging
ClinicalTrials.gov ID: NCT01030380
Acronym / sponsor ID: Face / BMR-09-2009
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Bio-Medical Research, Ltd.Industry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 11 Dec 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Slendertone Face NMES	Experimental	Device: Slendertone FaceSlendertone Face 20 minutes/day, 5 days/week for 12 weeks.
Control Group: No NMES	No intervention	–Control Group: No NMES over the course of 12 weeks.

Who may qualify

Ages: 25 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (16 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Slendertone FaceAlso: Slendertone Face, Type 371, Class II, Powered Muscle StimulatorSlendertone Face 20 minutes/day, 5 days/week for 12 weeks.	Device	Slendertone Face NMES

Primary outcome

Ultrasound measurements of the zygomaticus major muscle
Time frame: 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

1 secondary outcome

Ease of Use and Overall Acceptance of the Slendertone Face device
Time frame: End of Week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
Background: PubMed 19338976Coleman SR, Grover R. The anatomy of the aging face: volume loss and changes in 3-dimensional topography. Aesthet Surg J. 2006 Jan-Feb;26(1S):S4-9. doi: 10.1016/j.asj.2005.09.012.
Background: PubMed 16407433Rexbye H, Petersen I, Johansens M, Klitkou L, Jeune B, Christensen K. Influence of environmental factors on facial ageing. Age Ageing. 2006 Mar;35(2):110-5. doi: 10.1093/ageing/afj031. Epub 2006 Jan 11.
Background: PubMed 11041074Roubenoff R. Sarcopenia and its implications for the elderly. Eur J Clin Nutr. 2000 Jun;54 Suppl 3:S40-7. doi: 10.1038/sj.ejcn.1601024.
Background: PubMed 2384222Branchet MC, Boisnic S, Frances C, Robert AM. Skin thickness changes in normal aging skin. Gerontology. 1990;36(1):28-35. doi: 10.1159/000213172.
Background: PubMed 11457684Zimbler MS, Kokoska MS, Thomas JR. Anatomy and pathophysiology of facial aging. Facial Plast Surg Clin North Am. 2001 May;9(2):179-87, vii.
Background: PubMed 6828830McMiken DF, Todd-Smith M, Thompson C. Strengthening of human quadriceps muscles by cutaneous electrical stimulation. Scand J Rehabil Med. 1983;15(1):25-8.
Background: PubMed 1864770Charette SL, McEvoy L, Pyka G, Snow-Harter C, Guido D, Wiswell RA, Marcus R. Muscle hypertrophy response to resistance training in older women. J Appl Physiol (1985). 1991 May;70(5):1912-6. doi: 10.1152/jappl.1991.70.5.1912.
Background: PubMed 15730336Bax L, Staes F, Verhagen A. Does neuromuscular electrical stimulation strengthen the quadriceps femoris? A systematic review of randomised controlled trials. Sports Med. 2005;35(3):191-212. doi: 10.2165/00007256-200535030-00002.
Background: PubMed 24431963Porcari JP, Miller J, Cornwell K, Foster C, Gibson M, McLean K, Kernozek T. The effects of neuromuscular electrical stimulation training on abdominal strength, endurance, and selected anthropometric measures. J Sports Sci Med. 2005 Mar 1;4(1):66-75. eCollection 2005 Mar 1.
Background: PubMed 11237275Quittan M, Wiesinger GF, Sturm B, Puig S, Mayr W, Sochor A, Paternostro T, Resch KL, Pacher R, Fialka-Moser V. Improvement of thigh muscles by neuromuscular electrical stimulation in patients with refractory heart failure: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2001 Mar;80(3):206-14; quiz 215-6, 224. doi: 10.1097/00002060-200103000-00011.
Background: PubMed 10716757Vanderthommen M, Depresseux JC, Dauchat L, Degueldre C, Croisier JL, Crielaard JM. Spatial distribution of blood flow in electrically stimulated human muscle: a positron emission tomography study. Muscle Nerve. 2000 Apr;23(4):482-9. doi: 10.1002/(sici)1097-4598(200004)23:43.0.co;2-i.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Hennessy, M.D. principal investigator

Chief of Neurology, Galway University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Slendertone Face in people with Facial Muscle Toning, run by Bio-Medical Research, Ltd. at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultrasound measurements of the zygomaticus major muscle (time frame: Baseline; End of Week 6; End of Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01030380, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.