Fine Lines and WrinklesNCT07890233
Efficacy of an LED Mask
A study testing Light emitting diode treatment in people with Fine Lines and Wrinkles and Skin Health, run by Therabody, Inc. at 1 site in United States.
Trial summary
The goal of this interventional study is to evaluate the efficacy and perception a commercial LED device in 110 healthy adult females and males between the ages of 35-65 years old, inclusively. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Fine Lines and Wrinkles, Skin Health, Skin Tone
- What is being tested?
- Light emitting diode treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 35-65 years (inclusively)
- In good general health
- Sex: Female and Male (approximately 10% male)
- Ethnicity: Open to all with representation of at least one completer across the following key ethnic groups: Hispanic, African American, and Asian.
- Fitzpatrick Skin Type: Open to all with representation of at least one completer within each Fitzpatrick skin type category (I-VI).
- Individuals presenting with self-perceived sensitive skin (approximately 50% of the population).
Show all 29Show fewer
- Individuals presenting with self-perceived redness (Fitz I-IV), visible and clogged pores, uneven skin tone and at least one (1) dark spot present on the face.
- Individuals with mild to moderate severity [scores 3-6 on the 10-point modified Griffiths scale] for the following attributes on their face as determined by a clinical expert grader:
- Firmness (Tactile)
- Firmness (Visual)
- Fine Lines (Visual)
- Wrinkles (Visual)
- Skin Radiance/Luminosity (Visual)
- Skin Sagginess (Visual)
- Skin Texture/Smoothness
- Dark Spot
- Skin Tone Evenness
- Contour of the Jawline
- Overall Skin Appearance
- Male subjects must have a clean-shaven face prior to each study visit. No facial hair will be permitted, and individuals must maintain same shave habits for the duration of the study. Also, males must avoid shaving on the day of each visit.
- Agree to wear the provided tanktop for each visit to allow replicate photographs to be taken during all time points of the study (Cell 1 only - if selected by the Sponsor).
- Capable and willing to read and understand English and agree to sign an informed consent and photographic release form.
- Free of any skin condition(s) and have no history of skin condition(s) at the test site(s) that could interfere with the purpose, conduct, or integrity of the study.
- Agree to avoid any professional face procedures (chemical peels, facial laser treatments, facials, Botox/fillers, etc.) during the course of the study.
- Agree to arrive at the testing facility for each visit with clean skin and without any products (i.e., lotions, creams, makeup, etc.) applied to the test area (face).
- Agree not to introduce new personal care products during the course of the study.
- Agree not to use any chemical exfoliants (AHA/BHA) products during the course of the study.
- Agree to not introduce any new face masks (LED or topical), except the test product provided, during course of the study.
- Agree to avoid excessive sun exposure and the use of artificial tanning methods for the duration of the study.
Who cannot join
- Individuals with any visible dermatological skin condition(s) that could interfere with the conduct of the study or increase the risks to the test subject (i.e., excessive redness or dryness, abnormal pigmentation, unusual mole).
- Individuals with any self-reported skin disorders, including a known history of allergies or other medical conditions (i.e., atopic eczema, psoriasis, or onychomycosis) which, in the opinion of the Clinical Investigator, could interfere with the conduct of the study, interpretation of results, or increase the risk of adverse reactions.
- Individuals with facial tattoos, eyelash extensions, rashes, scratches, scars, or burn marks on the test site (face) that may interfere with the study assessments. Natural-looking eyebrow tattoos and eyelash extensions are permitted as long as they keep it consistent throughout the study.
- Individuals who make chronic use of alcohol, tobacco, or recreational drugs.
- Individuals with chapped skin or open wounds (i.e., lacerations or abrasions) (self-reported or detected by testing facility staff).
- Individuals who have been diagnosed by a physician as having any neurological condition that reduces your touch or pain sensitivity, such as peripheral neuropathy.
Show all 16Show fewer
- Individuals who have photosensitivity (i.e., sun allergy) or are using photosensitive drugs such as Doxycycline, Tetracycline, Ciprofloxacin, Isotretinoin, Benzoyl Peroxide, etc.
- Individuals who have had chemical peels, facial laser treatments, facials, Botox/fillers, light therapy in the last month and not allowed during study.
- Individuals who have a known (self-reported) allergy to any cosmetic and/or personal care products, and LED devices.
- Women who are pregnant (self-reported), planning a pregnancy, or nursing a child during the study.
- Individuals taking medications or who have used topical or systemic medication within 14 days of study entry that could interfere with the test results, including any regimen of anti-inflammatory drugs, antihistamines, immunosuppressants, or retinoids
- Individuals currently under the treatment for asthma or diabetes (insulin-dependent only).
- Concurrent participation in any other study involving the face or neck, or in any studies testing oral supplements.
- Individuals who have participated in other studies for LED face devices in the past 3 months.
- Individuals who have Hashimoto's Disease, Rheumatoid Arthritis, or any other autoimmune disorder.
- Employees of ALS or their dependents and/or relatives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
ALS Global Clinical Studies
Purchase, New York, 10577
About this study
Official title: 12-week Study Evaluating the Efficacy of an LED Mask
The goal of this interventional study is to evaluate the efficacy and perception a commercial LED device in 110 healthy adult females and males between the ages of 35-65 years old, inclusively. The main questions it aims to answer are:
Does daily use of this commercial LED device improve overall skin appearance as measured by clinical tools (expert clinical grading, cutometer, digital photography, and VISIA-CR? Does daily use of this commercial LED device improve subjective skin appearance? Is daily use of this commercial LED device well tolerated?
Participants will complete a 9-minute LED treatment (4.5 minutes LED, 4.5 minutes LED+ infrared light therapy) with a commercially available device every day for 12 weeks. They will visit the clinic three times (baseline, 6 weeks, 12 weeks) for clinical grading of skin.
Read the detailed description
At-home LED (light-emitting diode) devices are one of the category's fastest-growing segments. Their appeal rests partly on clinical evidence that red and near-infrared light can contribute to factors associated with skin health. The central aim of this study is to investigate the effects of daily use of an at-home device that delivers a 9 minute treatment of red and near-infrared light therapy on skin health after 12 weeks. Participants will complete one baseline visit in order to assess the acute effects of this therapy. Outcomes measures, including expert assessment and participant subjective health of skin of the face, will be taken at 6 and 12 weeks of daily treatment.
- Conditions
- Fine Lines and Wrinkles, Skin Health, Skin Tone
- Being tested
- Light emitting diode treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light emitting diode treatmentDevice
Participants will use the device for a 9-minute treatment (4.5 min red light and 4.5 minutes red + infrared light therapy) 7 days a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Acute use of light emitting diode mask | Experimental | All participants will complete 12 weeks of daily usage of an at-home LED treatment device that is 9 minutes in length. Participants will report to the lab at three time points (baseline, 6 weeks and 12 weeks) for clinical assessments of skin health. Receives: Device: Light emitting diode treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expert Clinical Grading
Assessments will be performed by a trained clinical grader and skin attributes will be assessed using an Ordinal Scale of 0 to 9 (modified Griffiths scale) on all subjects' faces. Outcome measures include: Firmness, fine lines, wrinkles, skin sagginess, radiance/luminosity, skin texture/smoothness, dark spot, skin tone evenness, contour of the jawline, overal skin appearance
Measured: From enrollment to the end of treatment at 12 weeks
Subjective and objective tolerance to device use
Tolerance will be graded objectively through ratings performed by a clinical grader relating to erythema, dryness, and edema, rated on a 4-point scale (0 = none, 3 = severe intensity). Subjective tolerance will be graded by the participant relating to stinging, tingling, itching, and burning on a 4 point scale (0 = none; 3 = severe).
Measured: From enrollment to the end of treatment at 12 weeks
Cutometer
The cutometer measures the viscoelastic properties of the skin by measuring the skin's response to the application of a probe. The Cutometer MPA 580 (Courage and Khazaka, Germany) device will be set to 450 mbar of pressure with a 6 second run time (3 seconds on and 3 seconds off). The curves will result in curves of R0 (mm), R5 (arbitrary units) and R7 (arbitrary units).
Measured: From enrollment to the end of treatment at 12 weeks
VISIA-CR
The VISIA-CR is a clinical facial imaging system used to analyze skin conditions. Images are taken in a variety of positions (frontal, left and right profiles) in consistent lighting. Image analysis for fine lines/wrinkles, skin texture/roughness, dark spots/hyperpigmentation, pores and redness will be performed with the VISIA-CR software.
Measured: From enrollment to the end of treatment at 12 weeks
Digital Photography
Clinical photography involves analysis of high-resolution images taken at different angles (right profile, 45 degrees right, straight on, 45 degrees left and 90 degrees left) to compare in a side-by-side format at each time point.
Measured: From enrollment to the end of treatment at 12 weeks
Self-assessment questionnaire
Participants will complete their perceived experience and comfort of use. Skin benefits including: firmness, appearance of fine lines, wrinkles (depth and appearance), radiance, plumpness, evenness, texture, redness, pigmentation, oiliness, pore appearance, dark spots, tightness, sagginess, texture, blemishes, appearance, health, scars/imperfections. All questions are on a 6 point scale (strongly agree to strongly disagree)
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fine Lines and WrinklesStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Therabody, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890233
- Sponsor's protocol ID
- 5063
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 22 Oct 2026
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-week Study Evaluating the Efficacy of an LED Mask
- ClinicalTrials.gov ID
- NCT07890233
- Acronym / sponsor ID
- 5063
- Conditions
- Fine Lines and Wrinkles, Skin Health, Skin Tone
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Therabody, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 22 Oct 2026 (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 goal of this interventional study is to evaluate the efficacy and perception a commercial LED device in 110 healthy adult females and males between the ages of 35-65 years old, inclusively. The main questions it aims to answer are:
Does daily use of this commercial LED device improve overall skin appearance as measured by clinical tools (expert clinical grading, cutometer, digital photography, and VISIA-CR? Does daily use of this commercial LED device improve subjective skin appearance? Is daily use of this commercial LED device well tolerated?
Participants will complete a 9-minute LED treatment (4.5 minutes LED, 4.5 minutes LED+ infrared light therapy) with a commercially available device every day for 12 weeks. They will visit the clinic three times (baseline, 6 weeks, 12 weeks) for clinical grading of skin.
Detailed description
At-home LED (light-emitting diode) devices are one of the category's fastest-growing segments. Their appeal rests partly on clinical evidence that red and near-infrared light can contribute to factors associated with skin health. The central aim of this study is to investigate the effects of daily use of an at-home device that delivers a 9 minute treatment of red and near-infrared light therapy on skin health after 12 weeks. Participants will complete one baseline visit in order to assess the acute effects of this therapy. Outcomes measures, including expert assessment and participant subjective health of skin of the face, will be taken at 6 and 12 weeks of daily treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute use of light emitting diode mask | Experimental | Device: Light emitting diode treatmentAll participants will complete 12 weeks of daily usage of an at-home LED treatment device that is 9 minutes in length. Participants will report to the lab at three time points (baseline, 6 weeks and 12 weeks) for clinical assessments of skin health. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Age: 35-65 years (inclusively)
- In good general health
- Sex: Female and Male (approximately 10% male)
- Ethnicity: Open to all with representation of at least one completer across the following key ethnic groups: Hispanic, African American, and Asian.
- Fitzpatrick Skin Type: Open to all with representation of at least one completer within each Fitzpatrick skin type category (I-VI).
Key exclusion criteria (16 listed)
- Individuals with any visible dermatological skin condition(s) that could interfere with the conduct of the study or increase the risks to the test subject (i.e., excessive redness or dryness, abnormal pigmentation, unusual mole).
- Individuals with any self-reported skin disorders, including a known history of allergies or other medical conditions (i.e., atopic eczema, psoriasis, or onychomycosis) which, in the opinion of the Clinical Investigator, could interfere with the conduct of the study, interpretation of results, or increase the risk of adverse reactions.
- Individuals with facial tattoos, eyelash extensions, rashes, scratches, scars, or burn marks on the test site (face) that may interfere with the study assessments. Natural-looking eyebrow tattoos and eyelash extensions are permitted as long as they keep it consistent throughout the study.
- Individuals who make chronic use of alcohol, tobacco, or recreational drugs.
- Individuals with chapped skin or open wounds (i.e., lacerations or abrasions) (self-reported or detected by testing facility staff).
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 |
|---|---|---|
| Light emitting diode treatmentParticipants will use the device for a 9-minute treatment (4.5 min red light and 4.5 minutes red + infrared light therapy) 7 days a week for 12 weeks | Device | Acute use of light emitting diode mask |
Primary outcome
Expert Clinical Grading
Time frame: From enrollment to the end of treatment at 12 weeks
Assessments will be performed by a trained clinical grader and skin attributes will be assessed using an Ordinal Scale of 0 to 9 (modified Griffiths scale) on all subjects' faces. Outcome measures include: Firmness, fine lines, wrinkles, skin sagginess, radiance/luminosity, skin texture/smoothness, dark spot, skin tone evenness, contour of the jawline, overal skin appearance
Subjective and objective tolerance to device use
Time frame: From enrollment to the end of treatment at 12 weeks
Tolerance will be graded objectively through ratings performed by a clinical grader relating to erythema, dryness, and edema, rated on a 4-point scale (0 = none, 3 = severe intensity). Subjective tolerance will be graded by the participant relating to stinging, tingling, itching, and burning on a 4 point scale (0 = none; 3 = severe).
Cutometer
Time frame: From enrollment to the end of treatment at 12 weeks
The cutometer measures the viscoelastic properties of the skin by measuring the skin's response to the application of a probe. The Cutometer MPA 580 (Courage and Khazaka, Germany) device will be set to 450 mbar of pressure with a 6 second run time (3 seconds on and 3 seconds off). The curves will result in curves of R0 (mm), R5 (arbitrary units) and R7 (arbitrary units).
VISIA-CR
Time frame: From enrollment to the end of treatment at 12 weeks
The VISIA-CR is a clinical facial imaging system used to analyze skin conditions. Images are taken in a variety of positions (frontal, left and right profiles) in consistent lighting. Image analysis for fine lines/wrinkles, skin texture/roughness, dark spots/hyperpigmentation, pores and redness will be performed with the VISIA-CR software.
Digital Photography
Time frame: From enrollment to the end of treatment at 12 weeks
Clinical photography involves analysis of high-resolution images taken at different angles (right profile, 45 degrees right, straight on, 45 degrees left and 90 degrees left) to compare in a side-by-side format at each time point.
Self-assessment questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
Participants will complete their perceived experience and comfort of use. Skin benefits including: firmness, appearance of fine lines, wrinkles (depth and appearance), radiance, plumpness, evenness, texture, redness, pigmentation, oiliness, pore appearance, dark spots, tightness, sagginess, texture, blemishes, appearance, health, scars/imperfections. All questions are on a 6 point scale (strongly agree to strongly disagree)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Fine Lines and Wrinkles
Recruiting
Efficacy of Topical Niacinamide Riboside on the Signs of Facial Skin Aging
Skin Aging on Face, Skin Care Dermocosmetics
Not yet recruiting
A Clinical Trial to Evaluate the Effects of Naila's Collagen Marine Plus Food Supplement on Skin Hydration, Elasticity, Fine Lines and Wrinkles, and Hair and Nail Health
Skin Aging, Skin Hydration
Not yet recruitingPhase 4
Assess Injectable Hyaluronic Acid Gel for the Treatment of Volume Loss, Skin Laxity and Fine Lines
Fine Lines, Wrinkle
Not yet recruiting
Clinical Study to Assess Safety, Effectiveness and In-Use Tolerability of Saffron Extract Capsules for Improving Skin Health and Reducing Signs of Aging on Healthy Adult Male and Female Subjects.
Wrinkles, Fine Lines
RecruitingPhase 1/2
Autologous Adipose Cells Therapy
Hair Loss/Baldness, Wrinkle Appearance
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.
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 Light emitting diode treatment in people with Fine Lines and Wrinkles and Skin Health, 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 29 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: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Expert Clinical Grading (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 6 primary outcomes in all. 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 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.