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| Name | Class |
|---|---|
| Validate Claim Support | UNKNOWN |
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The present study aims to assess use of a microcurrent and cryotherapy device on skin health over an 8-week period using an at-home device that provides 15-minutes of microcurrent + cold therapy once daily. An additional aim is to assess the acute (i.e., single) use of microcurrent or microcurrent + cold therapy on measures of skin health. The primary question it seeks to answer is whether daily use of the TheraFace Pro Gen 2 alters facial skin characteristics. Secondary aims include collecting clinical images, professional photographs, and consumer perceptions of the device.
Participants between the ages of 25-65 with various skin types will be enrolled for participation. Participants will visit the clinic three times for collection of outcome metrics at baseline with microcurrent therapy, baseline 2 using microcurrent + cold therapy, and 8 weeks after baseline. Measurements include: expert clinical grading, digital imaging, subjective assessment of skin, and clinical grade-images.
At home treatments to minimize and/or reverse the effects of skin aging has been gaining popularity over time. Two treatments commonly used in spa-settings to achieve these goals are microcurrent therapy and cold-therapy. Microcurrent therapy is a gentle skin treatment that uses low-level voltage to stimulate the facial muscles. This low-level voltage is applied during microcurrent facials to help tone and firm the skin by causing subtle muscle contractions. Localized cold therapy helps reduce inflammation by narrowing blood vessels and decreasing blood flow to the treated area. The central aim of this study is to investigate both acute and chronic (8 weeks) use of an at-home device that delivers both microcurrent and cold therapy on skin health. Participants will complete two acute baseline visits in randomized order, microcurrent alone and microcurrent + cold therapy in order to assess the acute effects of this therapy. Participants will then complete 8-weeks of microcurrent + cold therapy lasting about 8 minutes/day using the Therabody TheraFace Pro Gen 2 at home. Outcome measures include expert assessment and participant subjective health of skin of the face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Application of Microcurrent by Esthetician | Experimental | A licensed esthetician will complete an 18-step routine on the right and left side of the face including: lower neck (glide), upper neck (glide), vertical neck (glide), neck contour (glide), neck contour (press + hold), jawline cradle (glide), jawline cradle (press + hold), jaw contour (glide), jaw contour (press + hold), cheek contour (glide), cheek contour (press + hold), cheekbone contour (glide), cheek contour (press + hold), brow lift (glide), brow lift (press + hold), eye contour (glide), eye contour (press + hold), inner brow (glide), & inner brow (press + hold). |
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| Chronic Use of Microcurrent + Cold Therapy | Experimental | All evaluations will occur after sitting in 15-minutes of ambient conditions. Participants will be instructed to use the TheraFace Pro Gen 2 for approximately 8 minutes a day following an 18-step routine on each side of the face. The steps include: ower neck (glide), upper neck (glide), vertical neck (glide), neck contour (glide), neck contour (press + hold), jawline cradle (glide), jawline cradle (press + hold), jaw contour (glide), jaw contour (press + hold), cheek contour (glide), cheek contour (press + hold), cheekbone contour (glide), cheek contour (press + hold), brow lift (glide), brow lift (press + hold), eye contour (glide), eye contour (press + hold), inner brow (glide), & inner brow (press + hold). Each location will receive ~10 seconds of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute Microcurrent Treatment | Device | The esthetician will apply only the microcurrent setting during the 18-step routine. |
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| Measure | Description | Time Frame |
|---|---|---|
| Expert grading | Expert clinical grading will be used to measure a variety of skin health appearance measures including: fine lines/wrinkles, firmness, elasticity, radiance plumping (lips), contour (cheeks), pore appearance, lift (mid-face and jowls), nasolabial folds, and skin tone evenness. These will be graded on a scale from 0 to 10, with 0 representing a positive outcome (i.e., no wrinkles) and 10 representing a negative outcome (i.e., numerous, deep wrinkles). These will be assessed by an expert grader. | 8-weeks |
| Cutometer | The Cutometer MPA 580 measures the viscoelastic properties of the skin using suction and a probe to determine the penetration depth using an optical measuring system. The resistance of the skin to be sucked up by the negative pressure (firmness) and its ability to return to its original position (elasticity) are calculated and displayed as curves. The Cutometer outputs include many parameters of different portions of the measurement curve including R0 (Uf, firmness), R2 (Ua/Uf, gross elasticity), R5 (Ur/Ue, net elasticity), R7 (Ur/Uf, elastic portion) and R9 (R3[last max amp]-R0[Uf], fatigue). Elasticity will be reported using the R5 (Ur/Ue) parameter, as the skin becomes more elastic this value will increase. Skin Firmness will be reported using the R0 (Uf) parameter, as the skin becomes firmer this value will decrease. R0 (elasticity) and R5 (firmness) will be the only two parameters provided. | 8 weeks |
| VISIA CR Imaging | The VISIA-CR is a clinical facial imaging system used to analyze skin conditions. Images are taken in a variety of lighting conditions (Standard 1, Raked, Cross Polarized, and Primos 3D) to assess wrinkle depth and texture. Images will be taken of the face, utilizing the following angles: 45 degrees right, straight on, and 45 degrees left with the following lighting conditions: Standard 1, Raked, Cross Polarized, and Primos 3D. Analysis is performed by Canfield. The VISIA-CR provides a percentile value compared to others with similar skin (the higher the better); the feature count (the lower the better) and the absolute score (the lower the better). | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Validated Claim Support | Teaneck | New Jersey | 07666 | United States |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Participants will recieve the acute microcurrent and microcurrent + cold treatment by a licensed esthitican in a randomized order. There will be one visit for each treatment with a 24hr washout. Then all participants will complete the 8-week chronic intervention.
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Participants will not know the order in which they are receiving treatment (microcurrent or microcurrent + cooling).
| Acute Microcurrent + cold therapy | Device | The esthetician will apply cold + microcurrent therapy during the 18-step routine. |
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| 8-week Chronic Use of Microcurrent + Cold Therapy | Device | Participants will be instructed to use the TheraFace Pro Gen 2 for approximately 8 minutes a day following an 18-step routine on each side of the face. The steps include: ower neck (glide), upper neck (glide), vertical neck (glide), neck contour (glide), neck contour (press + hold), jawline cradle (glide), jawline cradle (press + hold), jaw contour (glide), jaw contour (press + hold), cheek contour (glide), cheek contour (press + hold), cheekbone contour (glide), cheek contour (press + hold), brow lift (glide), brow lift (press + hold), eye contour (glide), eye contour (press + hold), inner brow (glide), & inner brow (press + hold). Each location will receive ~10 seconds of treatment. |
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| Clinical Photography |
Clinical photography involves analysis of high-resolution images taken at different angles (45 degrees right, straight on, 45 degrees left) to compare in a side-by-side format at each time point. Images at each time point will be compared to highlight key changes in skin condition. |
| 8 weeks |
| Participant perceptions of skin health | Participants will complete subjective questionnaires ranking the impact of the treatment on overall skin health measures, including: finelines, facial puffiness, bounce, resiliency, sculpting of jawline, firmness, lift, plumping (lips), texture, comfort, plumpness, facial contour, rejuvenation, skin tone, sagging skin, and liveliness. Participants will also rank enjoyment, convenience, ease of use, and comfort of device usage. All measures will be ranked on a 5-point Likert scale, with 0 indicating strongly disagree and 5 indicating strongly agree. | 8 weeks |