NCT07054710

Evaluation of the Efficacy of a Cosmetic Light Mask

Eurofins CRL Cosmetics, Inc. / "A Clinical Study to Evaluate the Efficacy and Consumer Perception of a Cosmetic Device and Obtain Images"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Therabody, Inc. · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Light-emitting diode (LED) light therapy has recently gained popularity as a treatment for various skin conditions, such as fine lines, wrinkles, and age spots. LED treatments that use different wavelengths, like red, blue, and infrared, have been adapted into at-home devices to make these treatments more affordable and accessible for consumers. The main objective of this study is to assess the impact of an at-home LED treatment on skin health over 12 weeks. Participants completed a 12-minute LED + vibration treatment using the Therabody TheraFace Mask Glo at home six days a week for 12 weeks. The seventh day of each week involved a 15-minute vibration-only treatment. Outcome measures included measures of skin health in the face.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-05
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-07-08
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study