Microcurrent + Cold Therapy for Skin Health

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Therabody, Inc.

Must not be taking: Anti-acne drugs, Retinoids, GLP1

Disqualifiers: Botox, Filler, Eczema, Psoriasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

* 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.

I am either male or female.

I am between 25 and 65 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Baseline

Participants complete two acute baseline visits in randomized order, microcurrent alone and microcurrent + cold therapy to assess acute effects

1-2 weeks

2 visits (in-person)

Chronic Treatment

Participants use the TheraFace Pro Gen 2 device for 8 minutes daily at home for microcurrent + cold therapy

8 weeks

3 visits (in-person) for outcome metrics collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TheraFace Pro Gen 2

How Is the Trial Designed?

Group I: Chronic Use of Microcurrent + Cold Therapy Experimental Treatment 1 Intervention

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.

Group II: Acute Application of Microcurrent by Esthetician Experimental Treatment 2 Interventions

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).

Who Is Running the Clinical Trial?

Therabody, Inc.

Lead Sponsor

Validate Claim Support

Collaborator