N/A
Completed N=38
The Effects of an LED Face Mask & Neck and Chest Mask On Skin Health
Skin Aging · Sun Damaged Skin
Source: ClinicalTrials.gov NCT07025837 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Percentage of Participants Reported as Having an Improvement in Overall Skin Health as Evaluated by Dermatologist Grading — 29 Participants
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 dermatologist assessment and participant perception.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reported as Having an Improvement in Overall Skin Health as Evaluated by Dermatologist Grading |
29 | — |
| PRIMARY Percentage of Participants Reported as Having an Improvement in Fine Lines and Wrinkles as Evaluated by Dermatologist Grading |
17 | — |
| PRIMARY Percentage of Participants Reported as Having an Improvement in Skin Pigmentation as Evaluated by Dermatologist Grading |
24 | — |
| PRIMARY Percentage of Participants Reported as Having an Improvement in Skin Redness as Evaluated by Dermatologist Grading |
26 | — |
| PRIMARY Percentage of Participants Reported as Having an Improvement in Signs of Aging as Evaluated by Dermatologist Grading. |
24 | — |
| SECONDARY Self-Reported Improvement in Overall Skin Hydration |
2.74; 3.05; 2.97; 3.14; 3.46; 3.35 | >0.9999 |
| SECONDARY Self-Reported Improvement in Skin Plumpness |
2.97; 3.21; 3.51; 3.76; 3.76; 3.86 | 0.1176 |
| SECONDARY Self-Reported Improvement in Skin Tone |
2.79; 3.05; 3.43; 3.62; 3.92; 3.89 | 0.9751 |
| SECONDARY Self-Reported Improvement in Skin Texture |
2.92; 3.32; 3.57; 3.73; 3.86; 3.95 | 0.0544 |
| SECONDARY Self-Reported Improvement in Facial Skin Glow |
2.50; 3.26; 3.57; 3.81; 3.81; 3.92 | 0.0001 sig |
| SECONDARY Self-Reported Improvement in Facial Skin Health |
3.05; 3.42; 3.68; 3.81; 3.76; 3.89 | 0.1438 |
| SECONDARY Self-Reported Improvement in Facial Skin Appearance |
2.79; 3.26; 3.51; 3.70; 3.86; 3.92 | 0.0041 sig |
| SECONDARY Self-Reported Improvement in Skin Tone Evenness. |
2.50; 2.97; 3.35; 3.46; 3.70; 3.97 | 0.0249 sig |
| SECONDARY Self-Reported Improvement in Facial Skin Clarity |
3.16; 3.26; 3.59; 3.70; 3.92; 3.92 | >0.9999 |
| SECONDARY Self-Reported Improvement in Lift and Firmness of Skin |
2.29; 2.76; 3.05; 3.11; 3.46; 3.46 | 0.0199 sig |
| SECONDARY Self-Reported Improvement in the Severity of Skin Redness |
2.55; 2.37; 2.22; 2.27; 2.03; 2.00 | 0.4438 |
| SECONDARY Self-Reported Improvement in the Severity of 'Crepey' Skin on the Neck & Chest |
2.58; 2.26; 2.24; 1.89; 1.81; 1.68 | 0.6148 |
| SECONDARY Self-Reported Improvement in the Severity of Dark Spots on the Skin of the Neck and Chest |
2.89; 2.21; 2.14; 1.89; 1.89; 1.84 | 0.0067 sig |
| SECONDARY Self-Reported Improvement in the Visibility of Fine Lines and Wrinkles on the Skin of the Neck and Chest. |
2.87; 2.45; 2.30; 2.11; 1.97; 2.00 | 0.1476 |
| SECONDARY Self-Reported Improvement in the Severity of Sagging on the Neck |
2.55; 2.18; 2.00; 1.89; 1.86; 1.81 | 0.3224 |
| SECONDARY Self-Reported Improvement in the Severity of Hyperpigmentation |
3.05; 2.68; 2.46; 2.32; 2.16; 2.19 | 0.3032 |
| SECONDARY Self-Reported Improvement in the Visibility of Facial Scars or Blemishes |
2.84; 2.63; 2.32; 2.08; 2.14; 1.95 | >0.9999 |
| SECONDARY Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles |
3.13; 2.71; 2.51; 2.49; 2.30; 2.24 | 0.0461 sig |
Eligibility Criteria
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)
- Antiar
Data sourced from ClinicalTrials.gov (NCT07025837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.