Evaluatation of a Microcurrent + Cold Therapy Device
Enrolling by invitation · Not applicable
Conditions studied: Skin Health
In brief
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.
Key facts
- Study ID
- NCT07510581
- Run by
- Therabody, Inc.
- People needed
- 100
- Starts
- 2026-04-01
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2026-04-03
Who can join
Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.).
Where it is running
- Validated Claim Support — Teaneck, New Jersey, United States
Full record on ClinicalTrials.gov
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