Evaluation of the Efficacy of a Cosmetic Light Mask

Completed · Not applicable

Conditions studied: Fine Lines, Contour, Sagging Skin, Dark Spots, Wrinkles, Firmness, Skin Tone, Radiance/Luminosity

In brief

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.

Key facts

Study ID: NCT07054710
Run by: Therabody, Inc.
People needed: 115
Starts: 2025-05-05
Expected to finish: 2025-09-01
Last updated by the study team: 2025-09-09

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is female or male (approximately 90% female and 10% male)
Subject is between the ages of 35-65
Male subjects agree to remove all facial hair 24-48 hours prior to each visit and remain clean shaven daily throughout the study
Subject is of any Fitzpatrick (at least one of each, to be recorded)
Subject is of any of the following (Caucasian, African American, Asian, Hispanic) (at least one of each, to be recorded)
Subject has Self-Perceived Sensitive skin or Self-Perceived Non-Sensitive skin (approximately 50% sensitive and 50% non-sensitive)
Subject has the following on face (mild or greater):
Fine lines, ≥3 on 10-point scale Wrinkles, ≥3 on 10-point scale Dull skin, ≥3 on 10-point scale Sagging, ≥3 on 10-point scale Uneven skin tone Roughness/texture At least one dark spot
Subject agrees to return all used and unused test materials at the end of the study
Subjects will use their regular SPF product or will use an SPF product provided by the Sponsor (if they do not have an SPF product) and practice sun safe practices for the duration of the study (Hat, sunglasses, etc.)
Subject agrees not to introduce any new cosmetic or toiletry products during the study other than the products provided in this study
Subject is willing to use a cosmetic device on their face
Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits
Subject is willing to participate in all study evaluations
Subject is in generally good health and has a current Panelist Profile Form on file at ECRL
Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study
Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164
Subject understands and has signed an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Subjects."

You may not qualify if…

Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control
Subject has been part of a clinical test for a LED device, microcurrent device or other facial device within the last 6 months
Subject has eye sensitivity to light that may interfere with the use/application of the test product
Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study
Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study
Subject has a history of atopic eczema, psoriasis, or onychomycosis
Subject chronically uses substances such as alcohol, tobacco, recreational drugs, etc.
Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study
Subject exhibits any facial tattoos/tattooed cosmetics, eyelash extensions, rashes, scratches, scars, or burn marks on the test site (face) which may interfere with the study
Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs
Subject is unable to communicate or cooperate with the Principal Investigator, language problems, etc.
Subject is on another study utilizing the same test sites (Face)
Subject is an employee of testing firms/laboratories, cosmetic or raw goods manufacturers or suppliers
Subject has any planned medical or cosmetic procedures planned during the course of the study that, at the discretion of the Principal Investigator, may interfere with the study
Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind
Subject has diabetes.

Where it is running

Eurofins CRL Cosmetics, Inc — Piscataway, New Jersey, United States

Full record on ClinicalTrials.gov

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