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

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging; Sun Damaged Skin
• Intervention / Treatment: Device: iRESTORE Illumina LED Face Mask and Neck & Chest Mask

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89118
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.
• 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

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iRESTORE Illumina LED Device Group; All 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.	Device: iRESTORE Illumina LED Face Mask and Neck & Chest Mask; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 12
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.	Baseline, Week 12
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.	Baseline, Week 12
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.	Baseline, Week 12.
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.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

Collaborators and Investigators

• Sponsor: Freedom Laser, Inc.
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Actual): February 5, 2025
• Study Completion (Actual): February 5, 2025

Study Registration Dates

• First Submitted: June 10, 2025
• First Submitted That Met QC Criteria: June 10, 2025
• First Posted (Actual): June 18, 2025

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Skin Health; Neck and Chest Mask
• Other Study ID Numbers: 20679 (University of Waterloo Ethics)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No