Clinical trial NCT07025837: The Effects of an LED Face Mask & Neck and Chest Mask On Skin Health
Official title: The Effects of an LED Face Mask & Neck and Chest Mask On Skin Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Sun Damaged Skin
Keywords: Skin Health
Neck and Chest Mask
Lead sponsor: Freedom Laser, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2025-06-18
Enrollment: 38
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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)
* 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.

Primary outcomes:
measure: Change in skin appearance as evaluated by dermatologist grading
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change in participant perception of skin health
timeFrame: Baseline, Week 2, 4, 6, 8, 10, and 12
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Citruslabs
state: Nevada
Study officials:
References: