NCT07510581

Evaluatation of a Microcurrent + Cold Therapy Device

An 8 Week Randomized, Crossover Study to Evaluate the Efficacy of a Microcurrent + Cold Therapy Device

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Therabody, Inc. · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Skin Health

Interventions

Type	Name	Description
DEVICE	Acute Microcurrent Treatment	The esthetician will apply only the microcurrent setting during the 18-step routine.
DEVICE	Acute Microcurrent + cold therapy	The esthetician will apply cold + microcurrent therapy during the 18-step routine.
DEVICE	8-week Chronic Use of Microcurrent + Cold Therapy	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-05-31
• Completion: 2026-06-30
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study