Fine LinesNCT07054710
Evaluation of the Efficacy of a Cosmetic Light Mask
A study testing LED Light Treatment and Vibration Only in people with Fine Lines and Contour, run by Therabody, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Fine Lines, Contour, Sagging Skin
- What is being tested?
- LED Light Treatment and Vibration Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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."
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eurofins CRL Cosmetics, Inc
Piscataway, New Jersey, 08854
About this study
Official title: Eurofins CRL Cosmetics, Inc. / "A Clinical Study to Evaluate the Efficacy and Consumer Perception of a Cosmetic Device and Obtain Images"
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.
Read the 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
- Being tested
- LED Light Treatment, Vibration Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED Light TreatmentDevice
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.
Vibration OnlyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Daily LED and Vibration Use | Experimental | Participants will use the device once daily for 12-15 minutes for 12-weeks. The device delivers LED (red light, red+infrared, and blue light) and vibration to the eye and scalp area. Receives: Device: LED Light Treatment; Device: Vibration Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall skin health appearance
Expert clinical grading, VISIA-CR imaging and participant perceptions will be used in conjunction to measure a variety of skin health appearance measures including: fine lines, wrinkles (including wrinkle depth), skin tone evenness, skin texture, firmness, contour, sagging skin, skin radiance and luminosity, skin texture and smoothness, and dark spot/aging spot appearance. The VISIA-CR is a clinical facial imaging system used to analyze skin conditions.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start5 May 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fine LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therabody, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins CRL Cosmetics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054710
- Sponsor's protocol ID
- ECRLNJ2025-0269 BI
- Status last verified
- Sep 2025
- First submitted
- 27 Jun 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eurofins CRL Cosmetics, Inc. / "A Clinical Study to Evaluate the Efficacy and Consumer Perception of a Cosmetic Device and Obtain Images"
- ClinicalTrials.gov ID
- NCT07054710
- Acronym / sponsor ID
- ECRLNJ2025-0269 BI
- Conditions
- Fine Lines, Contour, Sagging Skin, Dark Spots, Wrinkles, Firmness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Therabody, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eurofins CRL Cosmetics, Inc.
- Study start
- 5 May 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily LED and Vibration Use | Experimental | Device: LED Light Treatment, Device: Vibration OnlyParticipants will use the device once daily for 12-15 minutes for 12-weeks. The device delivers LED (red light, red+infrared, and blue light) and vibration to the eye and scalp area. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LED Light TreatmentThe 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 | Daily LED and Vibration Use |
| Vibration OnlyOn 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. | Device | Daily LED and Vibration Use |
Primary outcome
Overall skin health appearance
Time frame: 12-weeks
Expert clinical grading, VISIA-CR imaging and participant perceptions will be used in conjunction to measure a variety of skin health appearance measures including: fine lines, wrinkles (including wrinkle depth), skin tone evenness, skin texture, firmness, contour, sagging skin, skin radiance and luminosity, skin texture and smoothness, and dark spot/aging spot appearance. The VISIA-CR is a clinical facial imaging system used to analyze skin conditions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED Light Treatment and Vibration Only in people with Fine Lines and Contour, run by Therabody, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall skin health appearance (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.