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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iRESTORE Illumina LED Device Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iRESTORE Illumina LED Face Mask and Neck & Chest Mask | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Las Vegas | Nevada | 89118 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Baseline, Week 12 |
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Participants were asked if they experienced any other effects at the end of the study Week 12.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eyes | Eye disorders | Non-systematic Assessment | One person reported experiencing dry eyes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Renner | Citruslabs | 4242450285 | hello@citruslabs.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2024 | Jul 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 14, 2024 | Jul 4, 2025 | ICF_001.pdf |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
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| 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. | Posted | Count of Participants | Participants | Baseline, Week 12 |
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| 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. | Posted | Count of Participants | Participants | Baseline, Week 12 |
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| 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. | Posted | Count of Participants | Participants | Baseline, Week 12. |
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| 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. | Posted | Count of Participants | Participants | Baseline, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Error | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 |
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|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 1 |
| 38 |
|
Not provided
Not provided
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
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| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | 0.6342 | Week 6 compared to baseline. | Superiority |
| ANOVA | 0.0231 | Week 8 compared to baseline. | Superiority |
| ANOVA | 0.0862 | Week 10 compared to baseline. | Superiority |
| ANOVA | 0.0033 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | 0.0001 | Week 6 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | 0.0003 | Week 6 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | 0.0001 | Week 6 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 12 compared to Baseline | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | <0.0001 | Week 6 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | 0.0003 | Week 6 compared to baseline. | Superiority |
| ANOVA | 0.0015 | Week 8 compared to baseline. | Superiority |
| ANOVA | 0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | <0.0001 | Week 6 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | <0.0001 | Week 6 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline
| Superiority |
| ANOVA | 0.2118 | Week 6 compared to baseline. | Superiority |
| ANOVA | 0.0111 | Week 8 compared to baseline. | Superiority |
| ANOVA | 0.0150 | Week 10 compared to baseline. | Superiority |
| ANOVA | 0.0003 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | <0.0001 | Week 6 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline | Superiority |
| ANOVA | <0.0001 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | 0.0943 | Week 6 compared to baseline | Superiority |
| ANOVA | 0.0017 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | 0.0007 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | 0.0019 | Week 6 compared to baseline. | Superiority |
| ANOVA | 0.0008 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | 0.0002 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | <0.0001 | Week 6 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | 0.0002 | Week 6 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 8 compared to baseline | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | 0.0039 | Week 6 compared to baseline. | Superiority |
| ANOVA | 0.0040 | Week 8 compared to baseline. | Superiority |
| ANOVA | 0.0013 | Week 10 compared to baseline. | Superiority |
| ANOVA | 0.0005 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | 0.0010 | Week 6 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 8 compared to baseline. | Superiority |
| ANOVA | 0.0002 | Week 10 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline
| Superiority |
| ANOVA | 0.0016 | Week 6 compared to baseline. | Superiority |
| ANOVA | 0.0048 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | 0.0005 | Week 12 compared to baseline. | Superiority |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 12 |
|
|
Week 4 compared to baseline.
| Superiority |
| ANOVA | 0.0002 | Week 6 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 8 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 10 compared to baseline. | Superiority |
| ANOVA | <0.0001 | Week 12 compared to baseline. | Superiority |