Evaluatation of a Microcurrent + Cold Therapy Device

NCT07510581 | Completed FDA Device

• 1 other identifier: PR251054.V03
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Health

Outcome Measures

Primary Outcomes (5)

• Expert grading

  Expert clinical grading will be used to measure a variety of skin health appearance measures including: fine lines/wrinkles, firmness, elasticity, radiance plumping (lips), contour (cheeks), pore appearance, lift (mid-face and jowls), nasolabial folds, and skin tone evenness. These will be graded on a scale from 0 to 10, with 0 representing a positive outcome (i.e., no wrinkles) and 10 representing a negative outcome (i.e., numerous, deep wrinkles). These will be assessed by an expert grader.

  8-weeks

• Cutometer

  The Cutometer MPA 580 measures the viscoelastic properties of the skin using suction and a probe to determine the penetration depth using an optical measuring system. The resistance of the skin to be sucked up by the negative pressure (firmness) and its ability to return to its original position (elasticity) are calculated and displayed as curves. The Cutometer outputs include many parameters of different portions of the measurement curve including R0 (Uf, firmness), R2 (Ua/Uf, gross elasticity), R5 (Ur/Ue, net elasticity), R7 (Ur/Uf, elastic portion) and R9 (R3\[last max amp\]-R0\[Uf\], fatigue). Elasticity will be reported using the R5 (Ur/Ue) parameter, as the skin becomes more elastic this value will increase. Skin Firmness will be reported using the R0 (Uf) parameter, as the skin becomes firmer this value will decrease. R0 (elasticity) and R5 (firmness) will be the only two parameters provided.

  8 weeks

• VISIA CR Imaging

  The VISIA-CR is a clinical facial imaging system used to analyze skin conditions. Images are taken in a variety of lighting conditions (Standard 1, Raked, Cross Polarized, and Primos 3D) to assess wrinkle depth and texture. Images will be taken of the face, utilizing the following angles: 45 degrees right, straight on, and 45 degrees left with the following lighting conditions: Standard 1, Raked, Cross Polarized, and Primos 3D. Analysis is performed by Canfield. The VISIA-CR provides a percentile value compared to others with similar skin (the higher the better); the feature count (the lower the better) and the absolute score (the lower the better).

  8 weeks

• Clinical Photography

  Clinical photography involves analysis of high-resolution images taken at different angles (45 degrees right, straight on, 45 degrees left) to compare in a side-by-side format at each time point. Images at each time point will be compared to highlight key changes in skin condition.

  8 weeks

• Participant perceptions of skin health

  Participants will complete subjective questionnaires ranking the impact of the treatment on overall skin health measures, including: finelines, facial puffiness, bounce, resiliency, sculpting of jawline, firmness, lift, plumping (lips), texture, comfort, plumpness, facial contour, rejuvenation, skin tone, sagging skin, and liveliness. Participants will also rank enjoyment, convenience, ease of use, and comfort of device usage. All measures will be ranked on a 5-point Likert scale, with 0 indicating strongly disagree and 5 indicating strongly agree.

  8 weeks

Study Arms (2)

Acute Application of Microcurrent by Esthetician

EXPERIMENTAL

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).

Device: Acute Microcurrent Treatment; Device: Acute Microcurrent + cold therapy

Chronic Use of Microcurrent + Cold Therapy

EXPERIMENTAL

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.

Device: 8-week Chronic Use of Microcurrent + Cold Therapy

Interventions

Acute Microcurrent Treatment DEVICE

The esthetician will apply only the microcurrent setting during the 18-step routine.

Acute Application of Microcurrent by Esthetician

Acute Microcurrent + cold therapy DEVICE

The esthetician will apply cold + microcurrent therapy during the 18-step routine.

Acute Application of Microcurrent by Esthetician

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.

Chronic Use of Microcurrent + Cold Therapy

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Therabody, Inc.: lead
• Validate Claim Support: collaborator

Study Sites (1)

Validated Claim Support

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know the order in which they are receiving treatment (microcurrent or microcurrent + cooling).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will recieve the acute microcurrent and microcurrent + cold treatment by a licensed esthitican in a randomized order. There will be one visit for each treatment with a 24hr washout. Then all participants will complete the 8-week chronic intervention.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 3, 2026
• Study Start: March 30, 2026
• Primary Completion: June 10, 2026
• Study Completion: September 1, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)