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

NCT01030380 | Completed Phase 3

• 1 other identifier: BMR-09-2009
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Ultrasound measurements of the zygomaticus major muscle

  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

  Baseline; End of Week 6 and End of Week 12

Secondary Outcomes (1)

• Ease of Use and Overall Acceptance of the Slendertone Face device

  End of Week 12

Study Arms (2)

Slendertone Face NMES

EXPERIMENTAL

Slendertone Face 20 minutes/day, 5 days/week for 12 weeks.

Device: Slendertone Face

Control Group: No NMES

NO INTERVENTION

Control Group: No NMES over the course of 12 weeks.

Interventions

Slendertone Face DEVICE

Slendertone Face 20 minutes/day, 5 days/week for 12 weeks.

Also known as: Slendertone Face, Type 371, Class II, Powered Muscle Stimulator

Slendertone Face NMES

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bio-Medical Research, Ltd.: lead

Study Sites (1)

Bio-Medical Research, Ltd.

Galway, County Galway, Ireland

Location

Related Publications (11)

• 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.

  PMID: 19338976 BACKGROUND

• 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.

  PMID: 16407433 BACKGROUND

• 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.

  PMID: 11041074 BACKGROUND

• 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.

  PMID: 2384222 BACKGROUND

• 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.

  PMID: 11457684 BACKGROUND

• 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.

  PMID: 6828830 BACKGROUND

• 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.

  PMID: 1864770 BACKGROUND

• 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.

  PMID: 15730336 BACKGROUND

• 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.

  PMID: 24431963 BACKGROUND

• 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.

  PMID: 11237275 BACKGROUND

• 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.

  PMID: 10716757 BACKGROUND

Study Officials

• Michael Hennessy, M.D.

  Chief of Neurology, Galway University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 11, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 11, 2009

Record last verified: 2009-12

Locations

IE (1)