Trial Outcomes & Findings for The Effects of an LED Face Mask & Neck and Chest Mask On Skin Health (NCT NCT07025837)
NCT ID: NCT07025837
Last Updated: 2025-10-14
Results Overview
Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in overall skin health.
COMPLETED
NA
38 participants
Baseline, Week 12
2025-10-14
Participant Flow
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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38
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Overall Study
COMPLETED
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36
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
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Age, Customized
25 to 55
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38 Participants
n=38 Participants
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Sex: Female, Male
Female
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38 Participants
n=38 Participants
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Sex: Female, Male
Male
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0 Participants
n=38 Participants
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Region of Enrollment
United States
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38 Participants
n=38 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 12Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in overall skin health.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=36 Participants
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.
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Percentage of Participants Reported as Having an Improvement in Overall Skin Health as Evaluated by Dermatologist Grading
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29 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 12Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in fine lines and wrinkles.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=36 Participants
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.
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Percentage of Participants Reported as Having an Improvement in Fine Lines and Wrinkles as Evaluated by Dermatologist Grading
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17 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 12Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in skin pigmentation.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=36 Participants
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.
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Percentage of Participants Reported as Having an Improvement in Skin Pigmentation as Evaluated by Dermatologist Grading
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24 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 12.Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in skin redness.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=36 Participants
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.
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Percentage of Participants Reported as Having an Improvement in Skin Redness as Evaluated by Dermatologist Grading
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26 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 12Participants will submit photos, which are reviewed by dermatologists using a standardized grading system to evaluate visible changes in signs of aging.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=36 Participants
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.
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Percentage of Participants Reported as Having an Improvement in Signs of Aging as Evaluated by Dermatologist Grading.
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24 Participants
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SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
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Self-Reported Improvement in Overall Skin Hydration
Baseline
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2.74 Score on a scale
Standard Deviation 0.98
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Self-Reported Improvement in Overall Skin Hydration
Week 2
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3.05 Score on a scale
Standard Deviation 1.18
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Self-Reported Improvement in Overall Skin Hydration
Week 4
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2.97 Score on a scale
Standard Deviation 1.09
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Self-Reported Improvement in Overall Skin Hydration
Week 6
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3.14 Score on a scale
Standard Deviation 1.00
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Self-Reported Improvement in Overall Skin Hydration
Week 8
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3.46 Score on a scale
Standard Deviation 1.12
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Self-Reported Improvement in Overall Skin Hydration
Week 10
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3.35 Score on a scale
Standard Deviation 1.11
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Self-Reported Improvement in Overall Skin Hydration
Week 12
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3.59 Score on a scale
Standard Deviation 1.09
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SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
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Self-Reported Improvement in Skin Plumpness
Baseline
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2.97 Score on a scale
Standard Deviation 0.75
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Self-Reported Improvement in Skin Plumpness
Week 2
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3.21 Score on a scale
Standard Deviation 0.84
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Self-Reported Improvement in Skin Plumpness
Week 4
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3.51 Score on a scale
Standard Deviation 0.73
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Self-Reported Improvement in Skin Plumpness
Week 6
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3.76 Score on a scale
Standard Deviation 0.64
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Self-Reported Improvement in Skin Plumpness
Week 8
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3.76 Score on a scale
Standard Deviation 0.64
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Self-Reported Improvement in Skin Plumpness
Week 10
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3.86 Score on a scale
Standard Deviation 0.63
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Self-Reported Improvement in Skin Plumpness
Week 12
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4.05 Score on a scale
Standard Deviation 0.62
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SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
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Self-Reported Improvement in Skin Tone
Baseline
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2.79 Score on a scale
Standard Deviation 0.78
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Self-Reported Improvement in Skin Tone
Week 2
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3.05 Score on a scale
Standard Deviation 0.96
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Self-Reported Improvement in Skin Tone
Week 4
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3.43 Score on a scale
Standard Deviation 0.77
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Self-Reported Improvement in Skin Tone
Week 6
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3.62 Score on a scale
Standard Deviation 0.76
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Self-Reported Improvement in Skin Tone
Week 8
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3.92 Score on a scale
Standard Deviation 0.68
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Self-Reported Improvement in Skin Tone
Week 10
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3.89 Score on a scale
Standard Deviation 0.66
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Self-Reported Improvement in Skin Tone
Week 12
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4.08 Score on a scale
Standard Deviation 0.68
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SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
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Self-Reported Improvement in Skin Texture
Baseline
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2.92 Score on a scale
Standard Deviation 0.94
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Self-Reported Improvement in Skin Texture
Week 2
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3.32 Score on a scale
Standard Deviation 0.84
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Self-Reported Improvement in Skin Texture
Week 4
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3.57 Score on a scale
Standard Deviation 0.69
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Self-Reported Improvement in Skin Texture
Week 6
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3.73 Score on a scale
Standard Deviation 0.69
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Self-Reported Improvement in Skin Texture
Week 8
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3.86 Score on a scale
Standard Deviation 0.75
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Self-Reported Improvement in Skin Texture
Week 10
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3.95 Score on a scale
Standard Deviation 0.57
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Self-Reported Improvement in Skin Texture
Week 12
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4.19 Score on a scale
Standard Deviation 0.57
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SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
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Self-Reported Improvement in Facial Skin Glow
Baseline
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2.50 Score on a scale
Standard Deviation 0.89
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Self-Reported Improvement in Facial Skin Glow
Week 2
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3.26 Score on a scale
Standard Deviation 1.00
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Self-Reported Improvement in Facial Skin Glow
Week 4
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3.57 Score on a scale
Standard Deviation 0.77
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Self-Reported Improvement in Facial Skin Glow
Week 6
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3.81 Score on a scale
Standard Deviation 0.66
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Self-Reported Improvement in Facial Skin Glow
Week 8
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3.81 Score on a scale
Standard Deviation 0.74
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Self-Reported Improvement in Facial Skin Glow
Week 10
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3.92 Score on a scale
Standard Deviation 0.64
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Self-Reported Improvement in Facial Skin Glow
Week 12
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4.16 Score on a scale
Standard Deviation 0.65
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SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
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Self-Reported Improvement in Facial Skin Health
Baseline
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3.05 Score on a scale
Standard Deviation 0.90
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Self-Reported Improvement in Facial Skin Health
Week 2
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3.42 Score on a scale
Standard Deviation 1.00
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Self-Reported Improvement in Facial Skin Health
Week 4
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3.68 Score on a scale
Standard Deviation 0.63
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Self-Reported Improvement in Facial Skin Health
Week 6
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3.81 Score on a scale
Standard Deviation 0.62
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Self-Reported Improvement in Facial Skin Health
Week 8
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3.76 Score on a scale
Standard Deviation 0.68
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Self-Reported Improvement in Facial Skin Health
Week 10
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3.89 Score on a scale
Standard Deviation 0.61
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Self-Reported Improvement in Facial Skin Health
Week 12
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4.16 Score on a scale
Standard Deviation 0.65
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SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
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Self-Reported Improvement in Facial Skin Appearance
Baseline
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2.79 Score on a scale
Standard Deviation 0.84
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Self-Reported Improvement in Facial Skin Appearance
Week 2
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3.26 Score on a scale
Standard Deviation 1.03
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Self-Reported Improvement in Facial Skin Appearance
Week 4
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3.51 Score on a scale
Standard Deviation 0.69
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Self-Reported Improvement in Facial Skin Appearance
Week 6
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3.70 Score on a scale
Standard Deviation 0.70
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Self-Reported Improvement in Facial Skin Appearance
Week 8
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3.86 Score on a scale
Standard Deviation 0.75
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Self-Reported Improvement in Facial Skin Appearance
Week 10
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3.92 Score on a scale
Standard Deviation 0.68
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Self-Reported Improvement in Facial Skin Appearance
Week 12
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4.08 Score on a scale
Standard Deviation 0.68
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SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
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Self-Reported Improvement in Skin Tone Evenness.
Baseline
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2.50 Score on a scale
Standard Deviation 0.83
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Self-Reported Improvement in Skin Tone Evenness.
Week 2
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2.97 Score on a scale
Standard Deviation 0.97
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Self-Reported Improvement in Skin Tone Evenness.
Week 4
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3.35 Score on a scale
Standard Deviation 0.75
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Self-Reported Improvement in Skin Tone Evenness.
Week 6
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3.46 Score on a scale
Standard Deviation 0.80
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Self-Reported Improvement in Skin Tone Evenness.
Week 8
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3.70 Score on a scale
Standard Deviation 0.81
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Self-Reported Improvement in Skin Tone Evenness.
Week 10
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3.97 Score on a scale
Standard Deviation 0.76
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Self-Reported Improvement in Skin Tone Evenness.
Week 12
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4.00 Score on a scale
Standard Deviation 0.82
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SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
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|---|---|
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Self-Reported Improvement in Facial Skin Clarity
Week 2
|
3.26 Score on a scale
Standard Deviation 1.13
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Self-Reported Improvement in Facial Skin Clarity
Baseline
|
3.16 Score on a scale
Standard Deviation 1.13
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Self-Reported Improvement in Facial Skin Clarity
Week 4
|
3.59 Score on a scale
Standard Deviation 0.86
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Self-Reported Improvement in Facial Skin Clarity
Week 6
|
3.70 Score on a scale
Standard Deviation 0.94
|
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Self-Reported Improvement in Facial Skin Clarity
Week 8
|
3.92 Score on a scale
Standard Deviation 0.89
|
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Self-Reported Improvement in Facial Skin Clarity
Week 10
|
3.92 Score on a scale
Standard Deviation 0.92
|
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Self-Reported Improvement in Facial Skin Clarity
Week 12
|
4.14 Score on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
|
|---|---|
|
Self-Reported Improvement in Lift and Firmness of Skin
Baseline
|
2.29 Score on a scale
Standard Error 0.73
|
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Self-Reported Improvement in Lift and Firmness of Skin
Week 2
|
2.76 Score on a scale
Standard Error 0.88
|
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Self-Reported Improvement in Lift and Firmness of Skin
Week 4
|
3.05 Score on a scale
Standard Error 0.70
|
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Self-Reported Improvement in Lift and Firmness of Skin
Week 6
|
3.11 Score on a scale
Standard Error 0.70
|
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Self-Reported Improvement in Lift and Firmness of Skin
Week 8
|
3.46 Score on a scale
Standard Error 0.80
|
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Self-Reported Improvement in Lift and Firmness of Skin
Week 10
|
3.46 Score on a scale
Standard Error 0.90
|
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Self-Reported Improvement in Lift and Firmness of Skin
Week 12
|
3.57 Score on a scale
Standard Error 0.90
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
|
|---|---|
|
Self-Reported Improvement in the Severity of Skin Redness
Baseline
|
2.55 Score on a scale
Standard Deviation 0.89
|
|
Self-Reported Improvement in the Severity of Skin Redness
Week 2
|
2.37 Score on a scale
Standard Deviation 0.71
|
|
Self-Reported Improvement in the Severity of Skin Redness
Week 4
|
2.22 Score on a scale
Standard Deviation 0.67
|
|
Self-Reported Improvement in the Severity of Skin Redness
Week 6
|
2.27 Score on a scale
Standard Deviation 0.61
|
|
Self-Reported Improvement in the Severity of Skin Redness
Week 8
|
2.03 Score on a scale
Standard Deviation 0.69
|
|
Self-Reported Improvement in the Severity of Skin Redness
Week 10
|
2.00 Score on a scale
Standard Deviation 0.71
|
|
Self-Reported Improvement in the Severity of Skin Redness
Week 12
|
1.89 Score on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
|
|---|---|
|
Self-Reported Improvement in the Severity of 'Crepey' Skin on the Neck & Chest
Baseline
|
2.58 Score on a scale
Standard Deviation 0.89
|
|
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
|
|
Self-Reported Improvement in the Severity of 'Crepey' Skin on the Neck & Chest
Week 4
|
2.24 Score on a scale
Standard Deviation 0.80
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.80
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.60
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
|
|---|---|
|
Self-Reported Improvement in the Severity of Sagging on the Neck
Baseline
|
2.55 Score on a scale
Standard Deviation 0.83
|
|
Self-Reported Improvement in the Severity of Sagging on the Neck
Week 2
|
2.18 Score on a scale
Standard Deviation 0.95
|
|
Self-Reported Improvement in the Severity of Sagging on the Neck
Week 4
|
2.00 Score on a scale
Standard Deviation 0.85
|
|
Self-Reported Improvement in the Severity of Sagging on the Neck
Week 6
|
1.89 Score on a scale
Standard Deviation 0.91
|
|
Self-Reported Improvement in the Severity of Sagging on the Neck
Week 8
|
1.86 Score on a scale
Standard Deviation 0.79
|
|
Self-Reported Improvement in the Severity of Sagging on the Neck
Week 10
|
1.81 Score on a scale
Standard Deviation 0.78
|
|
Self-Reported Improvement in the Severity of Sagging on the Neck
Week 12
|
1.76 Score on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
|
|---|---|
|
Self-Reported Improvement in the Severity of Hyperpigmentation
Week 10
|
2.19 Score on a scale
Standard Deviation 0.84
|
|
Self-Reported Improvement in the Severity of Hyperpigmentation
Week 12
|
2.00 Score on a scale
Standard Deviation 0.82
|
|
Self-Reported Improvement in the Severity of Hyperpigmentation
Baseline
|
3.05 Score on a scale
Standard Deviation 0.77
|
|
Self-Reported Improvement in the Severity of Hyperpigmentation
Week 2
|
2.68 Score on a scale
Standard Deviation 1.04
|
|
Self-Reported Improvement in the Severity of Hyperpigmentation
Week 4
|
2.46 Score on a scale
Standard Deviation 0.80
|
|
Self-Reported Improvement in the Severity of Hyperpigmentation
Week 6
|
2.32 Score on a scale
Standard Deviation 0.82
|
|
Self-Reported Improvement in the Severity of Hyperpigmentation
Week 8
|
2.16 Score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
|
|---|---|
|
Self-Reported Improvement in the Visibility of Facial Scars or Blemishes
Baseline
|
2.84 Score on a scale
Standard Deviation 1.00
|
|
Self-Reported Improvement in the Visibility of Facial Scars or Blemishes
Week 2
|
2.63 Score on a scale
Standard Deviation 0.91
|
|
Self-Reported Improvement in the Visibility of Facial Scars or Blemishes
Week 4
|
2.32 Score on a scale
Standard Deviation 0.71
|
|
Self-Reported Improvement in the Visibility of Facial Scars or Blemishes
Week 6
|
2.08 Score on a scale
Standard Deviation 0.76
|
|
Self-Reported Improvement in the Visibility of Facial Scars or Blemishes
Week 8
|
2.14 Score on a scale
Standard Deviation 0.71
|
|
Self-Reported Improvement in the Visibility of Facial Scars or Blemishes
Week 10
|
1.95 Score on a scale
Standard Deviation 0.81
|
|
Self-Reported Improvement in the Visibility of Facial Scars or Blemishes
Week 12
|
2.03 Score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12Population: 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.
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.
Outcome measures
| Measure |
iRESTORE Illumina LED Device Group
n=38 Participants
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.
|
|---|---|
|
Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles
Baseline
|
3.13 Score on a scale
Standard Deviation 0.66
|
|
Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles
Week 2
|
2.71 Score on a scale
Standard Deviation 0.87
|
|
Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles
Week 4
|
2.51 Score on a scale
Standard Deviation 0.56
|
|
Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles
Week 6
|
2.49 Score on a scale
Standard Deviation 0.73
|
|
Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles
Week 8
|
2.30 Score on a scale
Standard Deviation 0.70
|
|
Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles
Week 10
|
2.24 Score on a scale
Standard Deviation 0.55
|
|
Self-Reported Improvement in the Visibility of Any Fine Lines and Wrinkles
Week 12
|
2.05 Score on a scale
Standard Deviation 0.62
|
Adverse Events
iRESTORE Illumina LED Device Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
iRESTORE Illumina LED Device Group
n=38 participants at risk
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.
|
|---|---|
|
Eye disorders
Dry eyes
|
2.6%
1/38 • Number of events 1 • Participants were asked if they experienced any other effects at the end of the study Week 12.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place