Skin Aging, Sun Damaged Skin
Conditions
Keywords
Skin Health, Neck and Chest Mask
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.
Interventions
DEVICEiRESTORE 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.
Sponsors
Citruslabs
Freedom Laser, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reported as Having an Improvement in Overall Skin Health as Evaluated by Dermatologist Grading | 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. |
| Percentage of Participants Reported as Having an Improvement in Fine Lines and Wrinkles as Evaluated by Dermatologist Grading | 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 | 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 | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Improvement in Facial Skin Health | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| Self-Reported Improvement in Facial Skin Appearance | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| Self-Reported Improvement in Skin Tone Evenness. | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| Self-Reported Improvement in Facial Skin Clarity | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| Self-Reported Improvement in Lift and Firmness of Skin | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| Self-Reported Improvement in the Severity of Skin Redness | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| Self-Reported Improvement in Overall Skin Hydration | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| 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 | 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. |
| 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 | 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. |
| Self-Reported Improvement in the Severity of Sagging on the Neck | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| Self-Reported Improvement in the Severity of Hyperpigmentation | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| Self-Reported Improvement in the Visibility of Facial Scars or Blemishes | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| 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 | 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. |
| 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 | 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. |
| Self-Reported Improvement in Skin Plumpness | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| Self-Reported Improvement in Skin Tone | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| Self-Reported Improvement in Skin Texture | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
| Self-Reported Improvement in Facial Skin Glow | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | iRESTORE Illumina LED Device Group | — |
|---|---|---|
| Age, Customized 25 to 55 | 38 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 38 Participants | — |
| Sex: Female, Male Female | 38 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 1 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
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.
Time frame: Baseline, Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iRESTORE Illumina LED Device Group | Percentage of Participants Reported as Having an Improvement in Fine Lines and Wrinkles as Evaluated by Dermatologist Grading | 17 Participants |
Primary
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.
Time frame: Baseline, Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iRESTORE Illumina LED Device Group | Percentage of Participants Reported as Having an Improvement in Overall Skin Health as Evaluated by Dermatologist Grading | 29 Participants |
Primary
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.
Time frame: Baseline, Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iRESTORE Illumina LED Device Group | Percentage of Participants Reported as Having an Improvement in Signs of Aging as Evaluated by Dermatologist Grading. | 24 Participants |
Primary
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.
Time frame: Baseline, Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iRESTORE Illumina LED Device Group | Percentage of Participants Reported as Having an Improvement in Skin Pigmentation as Evaluated by Dermatologist Grading | 24 Participants |
Primary
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.
Time frame: Baseline, Week 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iRESTORE Illumina LED Device Group | Percentage of Participants Reported as Having an Improvement in Skin Redness as Evaluated by Dermatologist Grading | 26 Participants |
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Appearance | Baseline | 2.79 Score on a scale | Standard Deviation 0.84 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Appearance | Week 2 | 3.26 Score on a scale | Standard Deviation 1.03 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Appearance | Week 4 | 3.51 Score on a scale | Standard Deviation 0.69 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Appearance | Week 6 | 3.70 Score on a scale | Standard Deviation 0.7 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Appearance | Week 8 | 3.86 Score on a scale | Standard Deviation 0.75 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Appearance | Week 10 | 3.92 Score on a scale | Standard Deviation 0.68 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Appearance | Week 12 | 4.08 Score on a scale | Standard Deviation 0.68 |
p-value: 0.0041ANOVA
p-value: 0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Clarity | Baseline | 3.16 Score on a scale | Standard Deviation 1.13 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Clarity | Week 2 | 3.26 Score on a scale | Standard Deviation 1.13 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Clarity | Week 4 | 3.59 Score on a scale | Standard Deviation 0.86 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Clarity | Week 6 | 3.70 Score on a scale | Standard Deviation 0.94 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Clarity | Week 8 | 3.92 Score on a scale | Standard Deviation 0.89 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Clarity | Week 10 | 3.92 Score on a scale | Standard Deviation 0.92 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Clarity | Week 12 | 4.14 Score on a scale | Standard Deviation 0.86 |
p-value: >0.9999ANOVA
p-value: 0.7453ANOVA
p-value: 0.2118ANOVA
p-value: 0.0111ANOVA
p-value: 0.015ANOVA
p-value: 0.0003ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Glow | Baseline | 2.50 Score on a scale | Standard Deviation 0.89 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Glow | Week 2 | 3.26 Score on a scale | Standard Deviation 1 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Glow | Week 4 | 3.57 Score on a scale | Standard Deviation 0.77 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Glow | Week 6 | 3.81 Score on a scale | Standard Deviation 0.66 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Glow | Week 8 | 3.81 Score on a scale | Standard Deviation 0.74 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Glow | Week 10 | 3.92 Score on a scale | Standard Deviation 0.64 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Glow | Week 12 | 4.16 Score on a scale | Standard Deviation 0.65 |
p-value: 0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Health | Baseline | 3.05 Score on a scale | Standard Deviation 0.9 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Health | Week 2 | 3.42 Score on a scale | Standard Deviation 1 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Health | Week 4 | 3.68 Score on a scale | Standard Deviation 0.63 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Health | Week 6 | 3.81 Score on a scale | Standard Deviation 0.62 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Health | Week 8 | 3.76 Score on a scale | Standard Deviation 0.68 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Health | Week 10 | 3.89 Score on a scale | Standard Deviation 0.61 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Facial Skin Health | Week 12 | 4.16 Score on a scale | Standard Deviation 0.65 |
p-value: 0.1438ANOVA
p-value: 0.0092ANOVA
p-value: 0.0003ANOVA
p-value: 0.0015ANOVA
p-value: 0.0001ANOVA
p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Lift and Firmness of Skin | Baseline | 2.29 Score on a scale | Standard Error 0.73 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Lift and Firmness of Skin | Week 2 | 2.76 Score on a scale | Standard Error 0.88 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Lift and Firmness of Skin | Week 4 | 3.05 Score on a scale | Standard Error 0.7 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Lift and Firmness of Skin | Week 6 | 3.11 Score on a scale | Standard Error 0.7 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Lift and Firmness of Skin | Week 8 | 3.46 Score on a scale | Standard Error 0.8 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Lift and Firmness of Skin | Week 10 | 3.46 Score on a scale | Standard Error 0.9 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Lift and Firmness of Skin | Week 12 | 3.57 Score on a scale | Standard Error 0.9 |
p-value: 0.0199ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Overall Skin Hydration | Baseline | 2.74 Score on a scale | Standard Deviation 0.98 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Overall Skin Hydration | Week 2 | 3.05 Score on a scale | Standard Deviation 1.18 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Overall Skin Hydration | Week 4 | 2.97 Score on a scale | Standard Deviation 1.09 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Overall Skin Hydration | Week 6 | 3.14 Score on a scale | Standard Deviation 1 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Overall Skin Hydration | Week 8 | 3.46 Score on a scale | Standard Deviation 1.12 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Overall Skin Hydration | Week 10 | 3.35 Score on a scale | Standard Deviation 1.11 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Overall Skin Hydration | Week 12 | 3.59 Score on a scale | Standard Deviation 1.09 |
p-value: >0.9999ANOVA
p-value: >0.9999ANOVA
p-value: 0.6342ANOVA
p-value: 0.0231ANOVA
p-value: 0.0862ANOVA
p-value: 0.0033ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Plumpness | Baseline | 2.97 Score on a scale | Standard Deviation 0.75 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Plumpness | Week 2 | 3.21 Score on a scale | Standard Deviation 0.84 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Plumpness | Week 4 | 3.51 Score on a scale | Standard Deviation 0.73 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Plumpness | Week 6 | 3.76 Score on a scale | Standard Deviation 0.64 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Plumpness | Week 8 | 3.76 Score on a scale | Standard Deviation 0.64 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Plumpness | Week 10 | 3.86 Score on a scale | Standard Deviation 0.63 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Plumpness | Week 12 | 4.05 Score on a scale | Standard Deviation 0.62 |
p-value: 0.1176ANOVA
p-value: 0.003ANOVA
p-value: 0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Texture | Baseline | 2.92 Score on a scale | Standard Deviation 0.94 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Texture | Week 2 | 3.32 Score on a scale | Standard Deviation 0.84 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Texture | Week 4 | 3.57 Score on a scale | Standard Deviation 0.69 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Texture | Week 6 | 3.73 Score on a scale | Standard Deviation 0.69 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Texture | Week 8 | 3.86 Score on a scale | Standard Deviation 0.75 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Texture | Week 10 | 3.95 Score on a scale | Standard Deviation 0.57 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Texture | Week 12 | 4.19 Score on a scale | Standard Deviation 0.57 |
p-value: 0.0544ANOVA
p-value: 0.0036ANOVA
p-value: 0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone | Baseline | 2.79 Score on a scale | Standard Deviation 0.78 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone | Week 2 | 3.05 Score on a scale | Standard Deviation 0.96 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone | Week 4 | 3.43 Score on a scale | Standard Deviation 0.77 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone | Week 6 | 3.62 Score on a scale | Standard Deviation 0.76 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone | Week 8 | 3.92 Score on a scale | Standard Deviation 0.68 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone | Week 10 | 3.89 Score on a scale | Standard Deviation 0.66 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone | Week 12 | 4.08 Score on a scale | Standard Deviation 0.68 |
p-value: 0.9751ANOVA
p-value: 0.0078ANOVA
p-value: 0.0003ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone Evenness. | Baseline | 2.50 Score on a scale | Standard Deviation 0.83 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone Evenness. | Week 2 | 2.97 Score on a scale | Standard Deviation 0.97 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone Evenness. | Week 4 | 3.35 Score on a scale | Standard Deviation 0.75 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone Evenness. | Week 6 | 3.46 Score on a scale | Standard Deviation 0.8 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone Evenness. | Week 8 | 3.70 Score on a scale | Standard Deviation 0.81 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone Evenness. | Week 10 | 3.97 Score on a scale | Standard Deviation 0.76 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in Skin Tone Evenness. | Week 12 | 4.00 Score on a scale | Standard Deviation 0.82 |
p-value: 0.0249ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of 'Crepey' Skin on the Neck & Chest | Baseline | 2.58 Score on a scale | Standard Deviation 0.89 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of 'Crepey' Skin on the Neck & Chest | Week 2 | 2.26 Score on a scale | Standard Deviation 0.92 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of 'Crepey' Skin on the Neck & Chest | Week 4 | 2.24 Score on a scale | Standard Deviation 0.8 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of 'Crepey' Skin on the Neck & Chest | Week 6 | 1.89 Score on a scale | Standard Deviation 0.91 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of 'Crepey' Skin on the Neck & Chest | Week 8 | 1.81 Score on a scale | Standard Deviation 0.74 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of 'Crepey' Skin on the Neck & Chest | Week 10 | 1.68 Score on a scale | Standard Deviation 0.78 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of 'Crepey' Skin on the Neck & Chest | Week 12 | 1.76 Score on a scale | Standard Deviation 0.76 |
p-value: 0.6148ANOVA
p-value: 0.7953ANOVA
p-value: 0.0019ANOVA
p-value: 0.0008ANOVA
p-value: <0.0001ANOVA
p-value: 0.0002ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Dark Spots on the Skin of the Neck and Chest | Baseline | 2.89 Score on a scale | Standard Deviation 0.86 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Dark Spots on the Skin of the Neck and Chest | Week 2 | 2.21 Score on a scale | Standard Deviation 1.07 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Dark Spots on the Skin of the Neck and Chest | Week 4 | 2.14 Score on a scale | Standard Deviation 0.92 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Dark Spots on the Skin of the Neck and Chest | Week 6 | 1.89 Score on a scale | Standard Deviation 0.84 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Dark Spots on the Skin of the Neck and Chest | Week 8 | 1.89 Score on a scale | Standard Deviation 0.88 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Dark Spots on the Skin of the Neck and Chest | Week 10 | 1.84 Score on a scale | Standard Deviation 0.83 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Dark Spots on the Skin of the Neck and Chest | Week 12 | 1.73 Score on a scale | Standard Deviation 0.8 |
p-value: 0.0067ANOVA
p-value: 0.0055ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Hyperpigmentation | Baseline | 3.05 Score on a scale | Standard Deviation 0.77 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Hyperpigmentation | Week 2 | 2.68 Score on a scale | Standard Deviation 1.04 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Hyperpigmentation | Week 4 | 2.46 Score on a scale | Standard Deviation 0.8 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Hyperpigmentation | Week 6 | 2.32 Score on a scale | Standard Deviation 0.82 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Hyperpigmentation | Week 8 | 2.16 Score on a scale | Standard Deviation 0.83 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Hyperpigmentation | Week 10 | 2.19 Score on a scale | Standard Deviation 0.84 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Hyperpigmentation | Week 12 | 2.00 Score on a scale | Standard Deviation 0.82 |
p-value: 0.3032ANOVA
p-value: 0.0237ANOVA
p-value: 0.001ANOVA
p-value: <0.0001ANOVA
p-value: 0.0002ANOVA
p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Sagging on the Neck | Baseline | 2.55 Score on a scale | Standard Deviation 0.83 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Sagging on the Neck | Week 2 | 2.18 Score on a scale | Standard Deviation 0.95 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Sagging on the Neck | Week 4 | 2.00 Score on a scale | Standard Deviation 0.85 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Sagging on the Neck | Week 6 | 1.89 Score on a scale | Standard Deviation 0.91 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Sagging on the Neck | Week 8 | 1.86 Score on a scale | Standard Deviation 0.79 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Sagging on the Neck | Week 10 | 1.81 Score on a scale | Standard Deviation 0.78 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Sagging on the Neck | Week 12 | 1.76 Score on a scale | Standard Deviation 0.8 |
p-value: 0.3224ANOVA
p-value: 0.0426ANOVA
p-value: 0.0039ANOVA
p-value: 0.004ANOVA
p-value: 0.0013ANOVA
p-value: 0.0005ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Skin Redness | Baseline | 2.55 Score on a scale | Standard Deviation 0.89 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Skin Redness | Week 2 | 2.37 Score on a scale | Standard Deviation 0.71 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Skin Redness | Week 4 | 2.22 Score on a scale | Standard Deviation 0.67 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Skin Redness | Week 6 | 2.27 Score on a scale | Standard Deviation 0.61 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Skin Redness | Week 8 | 2.03 Score on a scale | Standard Deviation 0.69 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Skin Redness | Week 10 | 2.00 Score on a scale | Standard Deviation 0.71 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Severity of Skin Redness | Week 12 | 1.89 Score on a scale | Standard Deviation 0.77 |
p-value: 0.4438ANOVA
p-value: 0.0412ANOVA
p-value: 0.0943ANOVA
p-value: 0.0017ANOVA
p-value: <0.0001ANOVA
p-value: 0.0007ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles | Baseline | 3.13 Score on a scale | Standard Deviation 0.66 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles | Week 2 | 2.71 Score on a scale | Standard Deviation 0.87 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles | Week 6 | 2.49 Score on a scale | Standard Deviation 0.73 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles | Week 8 | 2.30 Score on a scale | Standard Deviation 0.7 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles | Week 10 | 2.24 Score on a scale | Standard Deviation 0.55 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles | Week 12 | 2.05 Score on a scale | Standard Deviation 0.62 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles | Week 4 | 2.51 Score on a scale | Standard Deviation 0.56 |
p-value: 0.0461ANOVA
p-value: 0.002ANOVA
p-value: 0.0002ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Facial Scars or Blemishes | Baseline | 2.84 Score on a scale | Standard Deviation 1 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Facial Scars or Blemishes | Week 2 | 2.63 Score on a scale | Standard Deviation 0.91 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Facial Scars or Blemishes | Week 4 | 2.32 Score on a scale | Standard Deviation 0.71 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Facial Scars or Blemishes | Week 6 | 2.08 Score on a scale | Standard Deviation 0.76 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Facial Scars or Blemishes | Week 8 | 2.14 Score on a scale | Standard Deviation 0.71 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Facial Scars or Blemishes | Week 10 | 1.95 Score on a scale | Standard Deviation 0.81 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Facial Scars or Blemishes | Week 12 | 2.03 Score on a scale | Standard Deviation 0.83 |
p-value: >0.9999ANOVA
p-value: 0.1147ANOVA
p-value: 0.0016ANOVA
p-value: 0.0048ANOVA
p-value: <0.0001ANOVA
p-value: 0.0005ANOVA
Secondary
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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Fine Lines and Wrinkles on the Skin of the Neck and Chest. | Baseline | 2.87 Score on a scale | Standard Deviation 0.74 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Fine Lines and Wrinkles on the Skin of the Neck and Chest. | Week 2 | 2.45 Score on a scale | Standard Deviation 0.76 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Fine Lines and Wrinkles on the Skin of the Neck and Chest. | Week 4 | 2.30 Score on a scale | Standard Deviation 0.81 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Fine Lines and Wrinkles on the Skin of the Neck and Chest. | Week 6 | 2.11 Score on a scale | Standard Deviation 0.88 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Fine Lines and Wrinkles on the Skin of the Neck and Chest. | Week 8 | 1.97 Score on a scale | Standard Deviation 0.6 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Fine Lines and Wrinkles on the Skin of the Neck and Chest. | Week 10 | 2.00 Score on a scale | Standard Deviation 0.67 |
| iRESTORE Illumina LED Device Group | Self-Reported Improvement in the Visibility of Fine Lines and Wrinkles on the Skin of the Neck and Chest. | Week 12 | 1.81 Score on a scale | Standard Deviation 0.81 |
p-value: 0.1476ANOVA
p-value: 0.0106ANOVA
p-value: 0.0002ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA