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Evaluation of the Efficacy of a Cosmetic Light Mask

NCT07054710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-09-09

No results posted yet for this study

Summary

The present study evaluated facial skin health over a 12-week period using an at-home device that provides 12 minutes of LED light and vibration once daily, six days a week. The primary question it seeks to answer is whether daily use of the TheraFace Mask Glo alters facial skin characteristics. Secondary aims include collecting clinical images, professional photographs, and consumer perceptions of the device.

Participants between the ages of 39-64 with various skin types were enrolled for participation. Participants visited the clinic three times for collection of outcome metrics at baseline, 8 weeks, and 12 weeks. Participants also came to the lab at 4 weeks for a compliance check. Measurements included: expert clinical grading, digital imaging, subjective assessment of skin, and clinical grade-images.

Conditions

  • Fine Lines
  • Contour
  • Sagging Skin
  • Dark Spots
  • Wrinkles
  • Firmness
  • Skin Tone
  • Radiance/Luminosity

Interventions

DEVICE

LED Light Treatment

The device will guide participants through a treatment that cycles through Red (4 minutes), Red + Infrared (4 minutes), and Blue (4 minutes) LED therapy in combination with vibration therapy, for a 12-minute treatment. Participants will be asked to use the device Monday through Saturday, on a clean face, as part of their evening routine.

DEVICE

Vibration Only

On each Sunday of the 12-week program, participants will be asked to complete a 15-minute vibration-only treatment session as part of their evening routine.

Sponsors & Collaborators

  • Eurofins CRL Cosmetics, Inc.

    collaborator UNKNOWN

  • Therabody, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-05
Primary Completion
2025-09-01
Completion
2025-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07054710 on ClinicalTrials.gov