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 — DEVICE
    The esthetician will apply only the microcurrent setting during the 18-step routine.
  • Acute Microcurrent + cold therapy — DEVICE
    The esthetician will apply cold + microcurrent therapy during the 18-step routine.
  • 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.

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 Esthetician
    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).
  • Experimental: Chronic Use of Microcurrent + Cold Therapy
    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.

Primary Outcome Measure

Expert grading [ Time Frame: 8-weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Validated Claim SupportTeaneckNew Jersey07666-

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