Evaluatation of a Microcurrent + Cold Therapy Device
Part of paid clinical trials in Teaneck, New Jersey.
- Sponsor
- Therabody, Inc.
- Study ID
- NCT07510581
- Status
- Enrolling By Invitation
Conditions
- Skin Health
Eligibility Criteria
- Sex
- ALL
- Age
- 25 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Acute Microcurrent Treatment — DEVICEThe esthetician will apply only the microcurrent setting during the 18-step routine.
- Acute Microcurrent + cold therapy — DEVICEThe esthetician will apply cold + microcurrent therapy during the 18-step routine.
- 8-week Chronic Use of Microcurrent + Cold Therapy — DEVICEParticipants 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.
Study Details
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 Dates
- Start date
- Apr 1, 2026
- Status verified
- Apr 2026
- Primary completion
- May 31, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Acute Application of Microcurrent by EstheticianA 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).
- Experimental: Chronic Use of Microcurrent + Cold TherapyAll 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.
Primary Outcome Measure
Expert grading [ Time Frame: 8-weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Validated Claim Support | Teaneck | New Jersey | 07666 | - |
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