The Effects of an LED Face Mask & Neck and Chest Mask On Skin Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Percentage of Participants Reported as Having an Improvement in Fine Lines and Wrinkles as Evaluated by Dermatologist Grading
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: iRESTORE Illumina LED Face Mask and Neck & Chest Mask (Device)
结局指标
主要结局
Percentage of Participants Reported as Having an Improvement in Fine Lines and Wrinkles as Evaluated by Dermatologist Grading
时间窗: Baseline, Week 12
Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in fine lines and wrinkles.
Percentage of Participants Reported as Having an Improvement in Skin Pigmentation as Evaluated by Dermatologist Grading
时间窗: Baseline, Week 12
Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in skin pigmentation.
Percentage of Participants Reported as Having an Improvement in Skin Redness as Evaluated by Dermatologist Grading
时间窗: Baseline, Week 12.
Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in skin redness.
Percentage of Participants Reported as Having an Improvement in Signs of Aging as Evaluated by Dermatologist Grading.
时间窗: Baseline, Week 12
Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in signs of aging.
Percentage of Participants Reported as Having an Improvement in Overall Skin Health as Evaluated by Dermatologist Grading
时间窗: Baseline, Week 12
Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in overall skin health.
次要结局
- Self-Reported Improvement in Overall Skin Hydration(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in Skin Plumpness(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in Facial Skin Appearance(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in Skin Tone(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in Skin Texture(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in Facial Skin Glow(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in Facial Skin Health(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in Skin Tone Evenness.(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in Facial Skin Clarity(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in Lift and Firmness of Skin(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in the Severity of Skin Redness(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(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(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.(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in the Severity of Sagging on the Neck(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in the Severity of Hyperpigmentation(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
- Self-Reported Improvement in the Visibility of Facial Scars or Blemishes(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(Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)