Evaluatation of a Microcurrent + Cold Therapy Device

Therabody, Inc.

Status: Invitation-only

Conditions: Skin Health

Treatments: Device: 8-week Chronic Use of Microcurrent + Cold Therapy; Device: Acute Microcurrent + cold therapy; Device: Acute Microcurrent Treatment

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07510581

PR251054.V03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is female or male (approximately 85% female and 15% male)
• Subject is between the ages of 25-65 (no more than 25% 55-65 per group)
• Individuals with fine lines/wrinkles, lack of firmness, dullness, and uneven skin tone with a grade of at least 3 on a 10-point scale.
• Individuals with sensitive skin.
• Individuals who are able to cooperate with the Principal Investigator and study personnel throughout the duration of the study and are willing to comply with all study procedures, methods, evaluations, and study product use.
• Individuals who are able to read and sign and informed consent.
• Individuals who are able to receive emails on their cellular phones and are capable of completing electronic Informed Consents and/or Questionnaires on their device.
• Individuals willing to be photographed and sign a model release.

Exclusion criteria

• Individuals who have had Botox in the last 3 months prior to Baseline.
• Individuals who have had Filler (Including Lip Filler) in the last 6 months prior to Baseline.
• Individuals with a history of atopic eczema, psoriasis, or onychomycosis.
• Individuals who have used a topical or system medication within 14 days prior to Baseline.
• Individuals who are on anti-acne drugs, topical and/or oral retinoids.
• Individuals currently on GLP1 medications or other weight loss regimens.
• Individuals who have used a beauty device of any kind in a clinical testing facility in the past 5 months prior to Baseline.
• Individuals who have used self-tanners and/or tanning beds within 14 days prior to Baseline.
• Individuals currently participating in other clinical studies that are testing a face product and/or device.
• Individuals with uncontrolled medical condition(s), including dermatological problems, which could put them at risk in the opinion of the Principal Investigator or compromise the study outcome and/or chronic or serious diseases and conditions which would prevent participation in this clinical study such as cancer, AIDS, insulin-dependent diabetes, renal impairment, mental illness, and/or drug/alcohol addiction.
• Individuals with a history of melanoma, or a treated skin cancer within the last 5 years.
• Individuals who are pregnant, lactating, or planning to become pregnant. -Individuals who become pregnant during the study must inform the Principal Investigator immediately.
• Individuals who are unreliable or unlikely to be available for the duration of the study.
• Individuals with a history of allergic reactions, skin sensitization and/or known allergies to cosmetic and personal care products/ingredients.
• Individuals who are immunocompromised.
• Individuals who are employees of VCS, other testing firms/laboratories, consumer products, and/or raw goods manufacturers/suppliers.
• Individuals who are unable to communicate or cooperate with the Principal Investigator/study personnel due to language problems, poor mental development, or impaired cerebral function.
• Individuals who started hormones within the last three months preceding the commencement of the study.
• Individuals who are using oral contraception for less than three months before study commencement or who have changed their contraceptive method within the three months before the Baseline visit or planning to modify their contraception treatment within the duration of the study.
• Individuals who have regular salon and/or dermatological procedures that can interfere with study results (Microdermabrasion, Fillers, Facial Peels, etc.) and are not willing to stop throughout the study.
• Individuals with facial tattoos and facial piercings (that can't be removed).
• Individuals with tattooed/permanent make up (i.e., eyeliner, eyebrows, lip liner, etc.), eyebrow microblading, and/or eyelash extensions.
• Individuals who plan to change their hairstyle throughout the course of the study or who wear hair coverings regularly (i.e., wigs, coloring, extensions, etc.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Acute Application of Microcurrent by Esthetician

Experimental group

Description:

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).

Treatment:

Device: Acute Microcurrent Treatment

Device: Acute Microcurrent + cold therapy

Chronic Use of Microcurrent + Cold Therapy

Experimental group

Description:

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.

Treatment:

Device: 8-week Chronic Use of Microcurrent + Cold Therapy