CTRI/2012/01/002325
Completed
未知
A single-center, randomized, controlled study to evaluate the safety and effectiveness of the electro muscular stimulation device to improve skin elasticity, firmness and to reduce the signs of facial aging in healthy adults after 10 weeks of product use - EMS Study
Vercel Inc0 sites70 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vercel Inc
- Enrollment
- 70
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.35 \- 50 years of age.( 40% male and 60% female )
- •2\.Visual signs of aging on the face with mild/moderate to severe wrinkles.
- •3\.In general good health,
- •Free of dermatological conditions such as eczema, seborrheic dermatitis and psoriasis.
- •4\.Signing of an Informed Consent Contract in conformance with CFR Part 50: Protection of Human Subjects.
- •5\.Dependability and intelligence in following directions.
- •6\.Completion of a Panelist Profile/Medical History.
- •7\.Subjects must be willing to maintain their normal diet throughout the duration of the study.
- •8\.Using acceptable methods of birth control.
Exclusion Criteria
- •1\.Pregnant women (or pregnancy within last 3 months).
- •2\.Inadequate precaution or procedure to prevent pregnancy (women of child\- bearing potential only).
- •3\.Treatment for any type of cancer within the last six months.
- •4\.Use of any prescribed anti\-inflammatory drug, immunosuppressive drugs or antihistamine medication (steroid nose drops and/or eye drops are permitted). Any over\-the\-counter pain medication that is ingested in quantities exceeding label instructions.
- •5\.Damaged skin in or around test sites which include sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles or other disfiguration of the test site.
- •6\.Individuals who have any implanted medical devices (pacemaker, pump, catheter, etc.).
- •7\.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.
- •8\.A current skin disease of any type at the test site (e.g. acne, eczema, psoriasis, burns, abrasions, etc.)
- •9\.Heavy alcohol consumption in the opinion of the investigator.
- •10\.A fever in the last 12 hours prior to the first application of the test device.
Outcomes
Primary Outcomes
Not specified
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