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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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.
Citruslabs
Las Vegas, Nevada, United States
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
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
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
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.
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
Self-Reported Improvement in Overall Skin Hydration
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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