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This research study will test how well a light therapy mask works for women with mild to moderate hyperpigmentation (brown spots) and moderate to severe facial wrinkles, as compared to a "sham" or inactive investigational light therapy mask. The study will also test if the light therapy mask causes any irritation. For the first 12 weeks of the study, participants will use the assigned mask, along with a provided cleanser and sunscreen. For the second 12 weeks of the study, participants will use just the cleanser and sunscreen.
Exposure to sunlight and artificial light sources containing ultraviolet (UV) radiation is known to accelerate the skin's aging process, resulting in unwanted wrinkles, irregular skin tone, and loss of elasticity. Ablative techniques, such as dermabrasion, deep chemical peels, and ablative laser resurfacing of various wavelengths, are well documented to alleviate the signs of photodamage. However, such techniques often require significant post-treatment care and have higher risk profiles than other treatments, with potential side effects including erythema, pigmentation issues, infection, and possible scarring. They may be poorly tolerated by patients who dislike the discomfort, wound care, and prolonged downtime involved.
Non-ablative skin rejuvenation procedures are also effective for improving the appearance of photodamaged skin and are becoming increasingly popular because of their minimal downtime and increased safety. These procedures include intense pulsed light systems, non-ablative lasers, and monochromatic light boxes, which can target facial rhytids, irregular pigmentation, telangiectasia, and skin laxity. Unfortunately, such techniques can be expensive and their use is primarily limited to clinical settings.
However, the light-emitting diode (LED) is a novel light source that is well-suited for non-ablative phototherapy that can be utilized at home for a relatively low price. This study will evaluate the efficacy and tolerance of an LED-based light therapy mask as compared to a sham mask in subjects seeking anti-aging benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Cell: Active Mask | Experimental | Cleanser, Moisturizer, Active Mask |
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| Sham Cell: Sham Mask | Sham Comparator | Cleanser, Moisturizer, Sham Mask |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Mask | Device | A facial cleanser will be used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF will be applied full-face. For the first 12 weeks of the study, the active light therapy mask will be used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage will be discontinued. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores | 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Baseline to Week 12 |
| Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1 | Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 1 were calculated individually. | Baseline to Week 12 |
| Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2 | Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 2 were calculated individually. | Baseline to Week 12 |
| Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3 | Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 3 were calculated individually. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Wrinkling - Change From Baseline to Week 1 | 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Baseline to Week 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Lessin, M.D. | KGL Skin Study Center, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGL Skin Study Center, LLC | Broomall | Pennsylvania | 19008 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9189680 | Background | Fitzpatrick RE. Laser resurfacing of rhytides. Dermatol Clin. 1997 Jul;15(3):431-47. doi: 10.1016/s0733-8635(05)70452-6. | |
| 16804006 | Background | McCullough JL, Kelly KM. Prevention and treatment of skin aging. Ann N Y Acad Sci. 2006 May;1067:323-31. doi: 10.1196/annals.1354.044. |
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At Visit 1 (Screening), participants were enrolled in the study and randomized to the active cell or the sham cell (stratified by skin type). All participants received the same facial cleanser and moisturizer with SPF to use between Visit 1 and Visit 2, and then received the assigned test product (Active Mask or Sham Mask) at Visit 2 (Baseline).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Cell: Sham Mask | A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued. |
| FG001 | Active Cell: Active Mask | A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Before Treatment (Screening to Baseline) |
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| Treatment (Baseline to Week 12) |
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| Regression (Week 12 to Week 24) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Cell: Sham Mask | A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued. |
| 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, Continuous | Mean |
| 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 | Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores | 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
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Adverse events (AEs) were collected from time of informed consent through subject's last study procedure (Week 24 unless terminated early). Serious adverse events (SAE) reported to the site were also reportable within 30 days of last procedure/visit and longer if considered study-related; there was no specific cut-off date for this reporting, but AEs/SAEs are shown in this posting for a collection period of approximately 6 months from last subject's visit (the time of this posting).
The Investigator or a designee interviewed subjects for changes in health/medication at each visit, documenting any reported adverse events. The analysis population is all randomized subjects who used the investigational device (i.e. the subjects enrolled in the treatment period).
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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 | Sham Cell: Sham Mask | A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden Death | General disorders | MedDRA 20.0 | Systematic Assessment | Subject died during the regression period. Event was classified as "not study-related." |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sidney Hornby | Johnson & Johnson Consumer Inc. | 908-874-2756 | SHornby@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2017 | Jan 4, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2018 | Jan 4, 2019 | SAP_001.pdf |
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| Sham Mask | Device | A facial cleanser will be used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF will be applied full-face. For the first 12 weeks of the study, the sham light therapy mask will be used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage will be discontinued. |
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| Global Wrinkling - Change From Baseline to Week 4 | 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Baseline to Week 4 |
| Global Wrinkling - Change From Baseline to Week 24 | 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Baseline to Week 24 |
| Fine Lines - Change From Baseline to Week 1 | 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | 1 week |
| Fine Lines - Change From Baseline to Week 4 | 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Baseline to Week 4 |
| Fine Lines - Change From Baseline to Week 12 | 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Baseline to Week 12 |
| Fine Lines - Change From Baseline to Week 24 | 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Baseline to Week 24 |
| Periorbital Wrinkles - Change From Baseline to Week 1 | 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Baseline to Week 1 |
| Periorbital Wrinkles - Change From Baseline to Week 4 | 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Baseline to Week 4 |
| Periorbital Wrinkles - Change From Baseline to Week 12 | 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Baseline to Week 12 |
| Periorbital Wrinkles - Change From Baseline to Week 24 | 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Baseline to Week 24 |
| Surface Roughness - Change From Baseline to Week 1 | 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Baseline to Week 1 |
| Surface Roughness - Change From Baseline to Week 4 | 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Baseline to Week 4 |
| Surface Roughness - Change From Baseline to Week 12 | 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Baseline to Week 12 |
| Surface Roughness - Change From Baseline to Week 24 | 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Week 24 |
| Uneven Skin Tone - Change From Baseline to Week 1 | 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Baseline to Week 1 |
| Uneven Skin Tone - Change From Baseline to Week 4 | 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Baseline to Week 4 |
| Uneven Skin Tone - Change From Baseline to Week 12 | 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Baseline to Week 12 |
| Uneven Skin Tone - Change From Baseline to Week 24 | 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Baseline to Week 24 |
| Mottled Hyperpigmentation - Change From Baseline to Week 1 | 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Baseline to Week 1 |
| Mottled Hyperpigmentation - Change From Baseline to Week 4 | 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Baseline to Week 4 |
| Mottled Hyperpigmentation - Change From Baseline to Week 12 | 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Baseline to Week 12 |
| Mottled Hyperpigmentation - Change From Baseline to Week 24 | 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Baseline to Week 24 |
| Sallowness/Yellowing - Change From Baseline to Week 1 | 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Baseline to Week 1 |
| Sallowness/Yellowing - Change From Baseline to Week 4 | 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Baseline to Week 4 |
| Sallowness/Yellowing - Change From Baseline to Week 12 | 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Baseline to Week 12 |
| Sallowness/Yellowing - Change From Baseline to Week 24 | 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Baseline to Week 24 |
| Lack of Radiance - Change From Baseline to Week 1 | 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Baseline to Week 1 |
| Lack of Radiance - Change From Baseline to Week 4 | 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Baseline to Week 4 |
| Lack of Radiance - Change From Baseline to Week 12 | 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Baseline to Week 12 |
| Lack of Radiance - Change From Baseline to Week 24 | 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Baseline to Week 24 |
| 12877228 | Background | Weiss RA, McDaniel DH, Geronemus RG. Review of nonablative photorejuvenation: reversal of the aging effects of the sun and environmental damage using laser and light sources. Semin Cutan Med Surg. 2003 Jun;22(2):93-106. doi: 10.1053/sder.2003.50008. |
| Background | Kim JW. Clinical trial of nonthermal 633 nm Omnilux LED array for renewal of photoaging: clinical surface profile metric results. Korea Soc Las Med Surg. 2005; 9:69-76. |
| 8629842 | Background | Fitzpatrick RE, Goldman MP, Satur NM, Tope WD. Pulsed carbon dioxide laser resurfacing of photo-aged facial skin. Arch Dermatol. 1996 Apr;132(4):395-402. |
| 1550366 | Background | Griffiths CE, Wang TS, Hamilton TA, Voorhees JJ, Ellis CN. A photonumeric scale for the assessment of cutaneous photodamage. Arch Dermatol. 1992 Mar;128(3):347-51. |
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| BG001 |
| Active Cell: Active Mask |
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Fitzpatrick Skin Type | Measure of skin type characteristics including sensitivity to burning/tanning. Ranges from I to VI, where I = white, very fair; red or blond hair; blue eyes; freckles; always burns easily, never tans. VI = Black; black hair, black eyes. Never burns, deeply pigmented. | Count of Participants | Participants |
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| Skin Oiliness Level | Self-perceived facial skin type in terms of oiliness level with answer choices of oily, dry, normal, or combination skin. | Count of Participants | Participants |
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| OG001 | Active Cell: Active Mask | A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued. |
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| Primary | Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1 | Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 1 were calculated individually. | Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects. | Posted | Mean | Standard Deviation | Units on a scale. | Baseline to Week 12 |
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| Primary | Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2 | Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 2 were calculated individually. | Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects. | Posted | Mean | Standard Deviation | Units on a scale. | Baseline to Week 12 |
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| Primary | Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3 | Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 3 were calculated individually. | Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects. | Posted | Mean | Standard Deviation | Units on a scale. | Baseline to Week 12 |
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| Secondary | Global Wrinkling - Change From Baseline to Week 1 | 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 1 |
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| Secondary | Global Wrinkling - Change From Baseline to Week 4 | 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 4 |
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| Secondary | Global Wrinkling - Change From Baseline to Week 24 | 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 24 |
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| Secondary | Fine Lines - Change From Baseline to Week 1 | 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 1 week |
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| Secondary | Fine Lines - Change From Baseline to Week 4 | 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 4 |
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| Secondary | Fine Lines - Change From Baseline to Week 12 | 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 12 |
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| Secondary | Fine Lines - Change From Baseline to Week 24 | 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 24 |
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| Secondary | Periorbital Wrinkles - Change From Baseline to Week 1 | 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 1 |
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| Secondary | Periorbital Wrinkles - Change From Baseline to Week 4 | 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 4 |
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| Secondary | Periorbital Wrinkles - Change From Baseline to Week 12 | 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 12 |
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| Secondary | Periorbital Wrinkles - Change From Baseline to Week 24 | 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 24 |
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| Secondary | Surface Roughness - Change From Baseline to Week 1 | 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 1 |
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| Secondary | Surface Roughness - Change From Baseline to Week 4 | 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 4 |
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| Secondary | Surface Roughness - Change From Baseline to Week 12 | 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 12 |
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| Secondary | Surface Roughness - Change From Baseline to Week 24 | 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Week 24 |
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| Secondary | Uneven Skin Tone - Change From Baseline to Week 1 | 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 1 |
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| Secondary | Uneven Skin Tone - Change From Baseline to Week 4 | 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 4 |
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| Secondary | Uneven Skin Tone - Change From Baseline to Week 12 | 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 12 |
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| Secondary | Uneven Skin Tone - Change From Baseline to Week 24 | 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 24 |
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| Secondary | Mottled Hyperpigmentation - Change From Baseline to Week 1 | 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 1 |
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| Secondary | Mottled Hyperpigmentation - Change From Baseline to Week 4 | 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 4 |
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| Secondary | Mottled Hyperpigmentation - Change From Baseline to Week 12 | 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 12 |
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| Secondary | Mottled Hyperpigmentation - Change From Baseline to Week 24 | 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 24 |
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| Secondary | Sallowness/Yellowing - Change From Baseline to Week 1 | 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 1 |
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| Secondary | Sallowness/Yellowing - Change From Baseline to Week 4 | 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 4 |
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| Secondary | Sallowness/Yellowing - Change From Baseline to Week 12 | 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 12 |
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| Secondary | Sallowness/Yellowing - Change From Baseline to Week 24 | 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 24 |
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| Secondary | Lack of Radiance - Change From Baseline to Week 1 | 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 1 |
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| Secondary | Lack of Radiance - Change From Baseline to Week 4 | 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 4 |
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| Secondary | Lack of Radiance - Change From Baseline to Week 12 | 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 12 |
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| Secondary | Lack of Radiance - Change From Baseline to Week 24 | 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement. | Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 24 |
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| 0 |
| 60 |
| 0 |
| 60 |
| 4 |
| 60 |
| EG001 | Active Cell: Active Mask | A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued. | 1 | 59 | 1 | 59 | 5 | 59 |
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| Oral Herpes | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
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| <0.001 |
| Mean Difference (Net) |
| 0.22 |
| Standard Deviation |
| 0.328 |
| 2-Sided |
| 95 |
| 0.13 |
| 0.31 |
| Superiority |
Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5. |
| ANCOVA | With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate. | 0.540 | Mean Difference (Net) | 0.04 | Standard Error of the Mean | 0.062 | 2-Sided | 95 | -0.09 | 0.16 | Equivalence | The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells. |
| 0.002 |
| Mean Difference (Net) |
| 0.21 |
| Standard Deviation |
| 0.500 |
| 2-Sided |
| 95 |
| 0.08 |
| 0.34 |
| Superiority |
Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5. |
| ANCOVA | With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate. | 0.009 | Mean Difference (Net) | 0.24 | Standard Error of the Mean | 0.092 | 2-Sided | 95 | 0.06 | 0.42 | Equivalence | The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells. |
| <0.001 |
| Mean Difference (Net) |
| 0.47 |
| Standard Deviation |
| 0.578 |
| 2-Sided |
| 95 |
| 0.32 |
| 0.63 |
| Superiority |
Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5. |
| ANCOVA | With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate. | 0.224 | Mean Difference (Net) | 0.11 | Standard Error of the Mean | 0.094 | 2-Sided | 95 | -0.07 | 0.30 | Equivalence | The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells. |