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Skin AgingNCT07025837

The Effects of an LED Face Mask & Neck and Chest Mask On Skin Health

A study testing iRESTORE Illumina LED Face Mask and Neck & Chest Mask in people with Skin Aging and Sun Damaged Skin, run by Freedom Laser, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 12-week single-group virtual study evaluates the effects of the iRESTORE Illumina LED Face Mask and Neck \& Chest Mask on skin health in adult females. Participants will use the devices daily for 10 minutes and complete scheduled surveys and photographs to assess improvements in skin appearance via both… Read more about this study

Who is it for?
Ages 25 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Skin Aging, Sun Damaged Skin
What is being tested?
iRESTORE Illumina LED Face Mask and Neck & Chest Mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
14 Oct 2024to 5 Feb 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Female
  • Aged 25-55 years.
  • Willing to follow the study protocols.
  • Self-reported issues with at least two of the following: Fine lines, Wrinkles, Hyperpigmentation, Dark spots, Reduced elasticity
  • Self-report concerns with at least one of the following: Crepey skin on the neck and chest, Sun damage on neck and chest
  • Willing to avoid introducing any new products, prescription medications, or supplements that target skin health during the study period.
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  • If taking oral supplements or herbal remedies targeted at skin health and appearance, have been consistently taking these for at least 3 months prior to starting the study.
  • Is willing to maintain the routine of any oral supplements or herbal remedies targeted at skin health and appearance for the duration of the study.
  • Has been using the same skincare routine for at least one month prior to the study start date.
  • Willing to maintain the same skincare routine and products throughout the study.
  • Willing to avoid direct sun exposure during the study duration
  • Willing to wear sunscreen if have to be in the sun

Who cannot join

  • Anyone who is extremely satisfied with their skin.
  • Anyone who has any chronic health conditions such as oncological (cancer) or psychiatric disorders.
  • Anyone who is planning to undergo facial treatments during the study period, including botox, dermal filler, chemical peels, etc. or has experienced any of these treatments in the last 3 months.
  • Anyone diagnosed with a skin condition affecting the face and/or neck who has had an active flare-up or breakout within the last year. This includes but is not limited to acne, eczema, psoriasis, rosacea, seborrheic dermatitis, vitiligo, urticaria (hives), warts, atopic dermatitis, melasma, and contact dermatitis.
  • Currently using any prescription medications that may affect the skin condition including but not limited to the following:
  • Corticosteroids like prednisone, methylprednisolone
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  • Antipsychotics like olanzapine (Zyprexa), risperidone (Risperdal), quetiapine (Seroquel)
  • SSRIs and SNRIs like fluoxetine (Prozac), sertraline (Zoloft), venlafaxine (Effexor)
  • Anticonvulsants like phenytoin (Dilantin), lamotrigine (Lamictal), and carbamazepine (Tegretol)
  • Antihypertensives like lisinopril (Zestril), amlodipine (Norvasc), and propranolol (Inderal)
  • Antithyroid medications like Tapazole (methimazole), Propyl-Thyracil (propylthiouracil)
  • Anyone with a history of skin cancer or precancerous skin lesions on the face.
  • Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.
  • Anyone who has any known allergies to ingredients commonly found in skincare products.
  • Anyone who is pregnant, breastfeeding, or trying to conceive
  • Anyone who cannot/will not commit to the study protocol.
  • Anyone with a history of substance abuse.
  • Anyone who has undergone an invasive medical procedure in the three weeks prior to the study or has a procedure planned during the study duration.
  • Anyone with a known allergic reaction to aluminum or plastics.
  • Anyone who suffers from any photosensitive disorder (sensitization to light).
  • Anyone with uncontrolled acne.
  • Anyone taking any prescription medication, over-the-counter supplements, or herbal supplements regularly (three or more days per week) that can cause photosensitivity including but not limited to the following:
  • Antibiotics like tetracyclines (e.g., doxycycline, tetracycline) or sulfonamides (e.g., Bactrim), fluoroquinolones (e.g., ciprofloxacin, levofloxacin)
  • Antifungals like Griseofulvin or Vfend (voriconazole)
  • Diuretics like drugs ending in -thiazides
  • NSAIDs like ibuprofen and Aleve (naproxen)
  • Retinoids or Vitamin A (e.g., Accutane (isotretinoin), (Retin-A) tretinoin
  • Antidepressants (e.g., SSRIs, Elavil (amitriptyline), Tofranil (imipramine)
  • Antihistamines like Phenergan (promethazine)
  • Antimalarial medications
  • Statins like Lipitor (atorvastatin), Zocor (simvastatin)
  • Antiarrhythmics like Pacerone (amiodarone)
  • St. John's wort
  • Anyone who suffers from light-induced headaches or migraines.
  • Anyone with a medical history of seizures or epilepsy triggered by light.
  • Anyone with an electronic implanted device such as a defibrillator, neurostimulator, pacemaker, or ECG monitor.
  • Anyone with a known history of carotid artery disease, stroke or transient ischemic attack (TIA), carotid stenosis, unstable blood pressure, easy fainting, thyroid disease, or of individuals about to undergo surgical procedures in the neck area.
  • Anyone who has stopped hormonal birth control in the past month.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Citruslabs

    Las Vegas, Nevada, 89118

Other trials in United States

About this study

This 12-week single-group virtual study evaluates the effects of the iRESTORE Illumina LED Face Mask and Neck \& Chest Mask on skin health in adult females. Participants will use the devices daily for 10 minutes and complete scheduled surveys and photographs to assess improvements in skin appearance via both dermatologist assessment and participant perception.

Being tested
iRESTORE Illumina LED Face Mask and Neck & Chest Mask
Keywords
Skin Health, Neck and Chest Mask

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iRESTORE Illumina LED Face Mask and Neck & Chest MaskDevice

    A pair of light-emitting diode (LED) therapy devices designed for at-home use. The facial and neck/chest masks deliver low-level red light therapy through embedded LEDs to improve visible signs of skin aging.

Study groups in NCT07025837
Study groupRoleWhat they receive
iRESTORE Illumina LED Device GroupExperimentalAll participants will use the iRESTORE LED Face Mask and Neck \& Chest Mask daily for 10 minutes each night. For the face mask, Mode 1 will be used.
Receives: Device: iRESTORE Illumina LED Face Mask and Neck & Chest Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Reported as Having an Improvement in Overall Skin Health as Evaluated by Dermatologist Grading

    Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in overall skin health.

    Measured: Baseline, Week 12

  2. Percentage of Participants Reported as Having an Improvement in Fine Lines and Wrinkles as Evaluated by Dermatologist Grading

    Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in fine lines and wrinkles.

    Measured: Baseline, Week 12

  3. Percentage of Participants Reported as Having an Improvement in Skin Pigmentation as Evaluated by Dermatologist Grading

    Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in skin pigmentation.

    Measured: Baseline, Week 12

  4. Percentage of Participants Reported as Having an Improvement in Skin Redness as Evaluated by Dermatologist Grading

    Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in skin redness.

    Measured: Baseline, Week 12.

  5. Percentage of Participants Reported as Having an Improvement in Signs of Aging as Evaluated by Dermatologist Grading.

    Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in signs of aging.

    Measured: Baseline, Week 12

Secondary outcomes (18)
  1. Self-Reported Improvement in Overall Skin Hydration

    This outcome measures the change in participant-reported scores for overall skin hydration from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale for skin hydration, including Extremely Dry (=1), Mildly Dry (=2), Neither dry nor hydrated (=3), Hydrated with room for improvement (=4), and Optimally hydrated (=5). Higher scores indicate greater improvement. This is a positively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  2. Self-Reported Improvement in Skin Plumpness

    This outcome measures the change in participant-reported scores for skin plumpness from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of plumpness, including Very bad (=1), Bad (=2), Neither good nor bad (=3), Good (=4), and Very good (=5). Higher scores indicate greater improvement. This is a positively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  3. Self-Reported Improvement in Skin Tone

    This outcome measures the change in participant-reported scores for skin tone from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale for skin tone, including Very bad (=1), Bad (=2), Neither good nor bad (=3), Good (=4), and Very good (=5). Higher scores indicate greater improvement. This is a positively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  4. Self-Reported Improvement in Skin Texture

    This outcome measures the change in participant-reported scores for skin texture from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of skin texture, including Very bad (=1), Bad (=2), Neither good nor bad (=3), Good (=4), and Very good (=5). Higher scores indicate greater improvement. This is a positively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  5. Self-Reported Improvement in Facial Skin Glow

    This outcome measures the change in participant-reported scores for facial skin glow from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of facial skin glow, including Very bad (=1), Bad (=2), Neither good nor bad (=3), Good (=4), and Very good (=5). Higher scores indicate greater improvement. This is a positively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  6. Self-Reported Improvement in Facial Skin Health

    This outcome measures the change in participant-reported scores for facial skin health from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of facial skin health, including Very bad (=1), Bad (=2), Neither good nor bad (=3), Good (=4), and Very good (=5). Higher scores indicate greater improvement. This is a positively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  7. Self-Reported Improvement in Facial Skin Appearance

    This outcome measures the change in participant-reported scores for facial skin appearance from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of facial skin appearance, including Very bad (=1), Bad (=2), Neither good nor bad (=3), Good (=4), and Very good (=5). Higher scores indicate greater improvement. This is a positively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  8. Self-Reported Improvement in Skin Tone Evenness.

    This outcome measures the change in participant-reported scores for skin tone evenness from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of skin tone evenness, including Very bad (=1), Bad (=2), Neither good nor bad (=3), Good (=4), and Very good (=5). Higher scores indicate greater improvement. This is a positively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  9. Self-Reported Improvement in Facial Skin Clarity

    This outcome measures the change in participant-reported scores for facial skin clarity from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of facial skin clarity, including Very bad (=1), Bad (=2), Neither good nor bad (=3), Good (=4), and Very good (=5). Higher scores indicate greater improvement. This is a positively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  10. Self-Reported Improvement in Lift and Firmness of Skin

    This outcome measures the change in participant-reported scores for lift and firmness of skin from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of skin lift and firmness, including Not at all (=1), A little bit (=2), Somewhat (=3), Very much (=4), and Extremely (=5). Higher scores indicate greater improvement. This is a positively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  11. Self-Reported Improvement in the Severity of Skin Redness

    This outcome measures the change in participant-reported scores for severity of skin redness from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of skin redness severity, including Not noticeable (=1), Barely noticeable (=2), Moderate (=3), Distracting (=4), and Severe (=5). Lower scores indicate greater improvement. This is a negatively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  12. Self-Reported Improvement in the Severity of 'Crepey' Skin on the Neck & Chest

    This outcome measures the change in participant-reported scores for the severity of 'crepey' skin on the neck \& chest from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of 'crepey' skin severity, including Not noticeable (=1), Barely noticeable (=2), Moderate (=3), Distracting (=4), and Severe (=5). Lower scores indicate greater improvement. This is a negatively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  13. Self-Reported Improvement in the Severity of Dark Spots on the Skin of the Neck and Chest

    This outcome measures the change in participant-reported scores for the severity of dark spots on the skin of the neck and chest from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of dark spot severity, including Not noticeable (=1), Barely noticeable (=2), Moderate (=3), Distracting (=4), and Severe (=5). Lower scores indicate greater improvement. This is a negatively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  14. Self-Reported Improvement in the Visibility of Fine Lines and Wrinkles on the Skin of the Neck and Chest.

    This outcome measures the change in participant-reported scores for the visibility of fine lines and wrinkles on the skin of the neck and chest from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of fine line and wrinkle visibility, including Not noticeable (=1), Barely noticeable (=2), Moderate (=3), Distracting (=4), and Severe (=5). Lower scores indicate greater improvement. This is a negatively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  15. Self-Reported Improvement in the Severity of Sagging on the Neck

    This outcome measures the change in participant-reported scores for the severity of sagging on the neck from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of sagging severity, including Not noticeable (=1), Barely noticeable (=2), Moderate (=3), Distracting (=4), and Severe (=5). Lower scores indicate greater improvement. This is a negatively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  16. Self-Reported Improvement in the Severity of Hyperpigmentation

    This outcome measures the change in participant-reported scores for the severity of hyperpigmentation from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of hyperpigmentation, including Not noticeable (=1), Barely noticeable (=2), Moderate (=3), Distracting (=4), and Severe (=5). Lower scores indicate greater improvement. This is a negatively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  17. Self-Reported Improvement in the Visibility of Facial Scars or Blemishes

    This outcome measures the change in participant-reported scores for the visibility of facial scars or blemishes from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of scar or blemish visibility, including Not noticeable (=1), Barely noticeable (=2), Moderate (=3), Distracting (=4), and Severe (=5). Lower scores indicate greater improvement. This is a negatively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

  18. Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles

    This outcome measures the change in participant-reported scores for the visibility of any fine lines and wrinkles from baseline to Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12, using a study-specific questionnaire. Each parameter was scored on a 5-point Likert scale of fine line and wrinkle visibility, including Not noticeable (=1), Barely noticeable (=2), Moderate (=3), Distracting (=4), and Severe (=5). Lower scores indicate greater improvement. This is a negatively weighted item.

    Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2025
  2. Study start14 Oct 2024
  3. Primary completion5 Feb 2025
  4. Study completion5 Feb 2025

Resources

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07025837
Sponsor's protocol ID
20679
Status last verified
Sep 2025
First submitted
10 Jun 2025
Last updated
14 Oct 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing iRESTORE Illumina LED Face Mask and Neck & Chest Mask in people with Skin Aging and Sun Damaged Skin, run by Freedom Laser, 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 12 inclusion and 38 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 14 Oct 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?

Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Reported as Having an Improvement in Overall Skin Health as Evaluated by Dermatologist Grading (time frame: Baseline, Week 12). The study lists 5 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 14 Oct 2025.

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