Skin Aging
Conditions
Keywords
Photoaging of Skin, Skin Wrinkling, Solar Aging of Skin, light therapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEActive Mask
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.
DEVICESham Mask
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.
Sponsors
Johnson & Johnson Consumer Inc. (J&JCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Has mild to moderate brown spots * Has moderate to severe facial wrinkling * Able to read, write, speak, and understand English * In general good health * If capable of having a child: must agree to practice a medically acceptable form of birth control. * Intends to complete the study and willing to follow all study directions.
Exclusion criteria
* Allergies/sensitivity to skincare products or the test product ingredients * Has a light or photosensitivity disorder or another medical condition that could increase risk to the subject or confuse the study results. * Is taking medication that may cause skin sensitivity to light * Has been using a product or medication that the study investigator determines will increase health risk to the subject or confuse the study results * Has a facial skin condition (e.g. rosacea, acne, eczema, etc.) that could increase health risk to the subject or confuse the study results. * Has skin cancer or a history of skin cancer. * Has an immune deficiency disorder, active hepatitis, or an autoimmune disease. * Has an uncontrolled metabolic condition (e.g. diabetes, hypertension) * Is pregnant, nursing, or planning to become pregnant. * Plans to start or change a hormone replacement therapy during the study. * Has participated in another study in the past 30 days or plans to during the study. * Is an employee or relative of the Study Site, Investigator, or Sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores | Baseline to Week 12 | 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. |
| Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1 | Baseline to Week 12 | 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. |
| Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2 | Baseline to Week 12 | 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. |
| Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3 | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fine Lines - Change From Baseline to Week 4 | 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. |
| Fine Lines - Change From Baseline to Week 12 | 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. |
| Fine Lines - Change From Baseline to Week 24 | 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. |
| Periorbital Wrinkles - Change From Baseline to Week 1 | 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. |
| Periorbital Wrinkles - Change From Baseline to Week 4 | 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. |
| Periorbital Wrinkles - Change From Baseline to Week 12 | 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. |
| Periorbital Wrinkles - Change From Baseline to Week 24 | 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. |
| Surface Roughness - Change From Baseline to Week 1 | 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. |
| Surface Roughness - Change From Baseline to Week 4 | 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. |
| Surface Roughness - Change From Baseline to Week 12 | 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. |
| Surface Roughness - Change From Baseline to Week 24 | 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. |
| Uneven Skin Tone - Change From Baseline to Week 1 | 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. |
| Uneven Skin Tone - Change From Baseline to Week 4 | 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. |
| Global Wrinkling - Change From Baseline to Week 1 | 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. |
| Uneven Skin Tone - Change From Baseline to Week 24 | 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. |
| Mottled Hyperpigmentation - Change From Baseline to Week 1 | 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. |
| Mottled Hyperpigmentation - Change From Baseline to Week 4 | 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. |
| Mottled Hyperpigmentation - Change From Baseline to Week 12 | 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. |
| Mottled Hyperpigmentation - Change From Baseline to Week 24 | 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. |
| Sallowness/Yellowing - Change From Baseline to Week 1 | 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. |
| Sallowness/Yellowing - Change From Baseline to Week 4 | 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. |
| Sallowness/Yellowing - Change From Baseline to Week 12 | 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. |
| Sallowness/Yellowing - Change From Baseline to Week 24 | 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. |
| Lack of Radiance - Change From Baseline to Week 1 | 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. |
| Lack of Radiance - Change From Baseline to Week 4 | 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. |
| Lack of Radiance - Change From Baseline to Week 12 | 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. |
| Lack of Radiance - Change From Baseline to Week 24 | 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. |
| Uneven Skin Tone - Change From Baseline to Week 12 | 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. |
| Global Wrinkling - Change From Baseline to Week 4 | 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. |
| Global Wrinkling - Change From Baseline to Week 24 | 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. |
| Fine Lines - Change From Baseline to Week 1 | 1 week | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| 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. | 63 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Before Treatment (Screening to Baseline) | Lost to Follow-up | 0 | 2 |
| Before Treatment (Screening to Baseline) | Withdrawal by Subject | 1 | 2 |
| Regression (Week 12 to Week 24) | Death | 0 | 1 |
| Regression (Week 12 to Week 24) | Protocol Violation | 1 | 1 |
| Treatment (Baseline to Week 12) | Protocol Violation | 1 | 1 |
| Treatment (Baseline to Week 12) | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Active Cell: Active Mask | Total | Sham Cell: Sham Mask |
|---|---|---|---|
| Age, Continuous | 56.6 Years STANDARD_DEVIATION 7.34 | 56.5 Years STANDARD_DEVIATION 7.65 | 56.3 Years STANDARD_DEVIATION 8.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 122 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type I | 11 Participants | 22 Participants | 11 Participants |
| Fitzpatrick Skin Type II | 11 Participants | 22 Participants | 11 Participants |
| Fitzpatrick Skin Type III | 11 Participants | 20 Participants | 9 Participants |
| Fitzpatrick Skin Type IV | 11 Participants | 21 Participants | 10 Participants |
| Fitzpatrick Skin Type V | 9 Participants | 19 Participants | 10 Participants |
| Fitzpatrick Skin Type VI | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 33 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 45 Participants | 90 Participants | 45 Participants |
| Sex: Female, Male Female | 63 Participants | 124 Participants | 61 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Skin Oiliness Level Combination | 29 Participants | 56 Participants | 27 Participants |
| Skin Oiliness Level Dry | 13 Participants | 22 Participants | 9 Participants |
| Skin Oiliness Level Normal | 17 Participants | 40 Participants | 23 Participants |
| Skin Oiliness Level Oily | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 1 / 59 |
| other Total, other adverse events | 4 / 60 | 5 / 59 |
| serious Total, serious adverse events | 0 / 60 | 1 / 59 |
Outcome results
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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores | 0.18 Units on a scale | Standard Deviation 0.328 |
| Active Cell: Active Mask | Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores | 0.30 Units on a scale | Standard Deviation 0.341 |
p-value: <0.00195% CI: [0.09, 0.26]t-test, 2 sided
p-value: <0.00195% CI: [0.21, 0.39]t-test, 2 sided
p-value: 0.02595% CI: [0.02, 0.25]ANCOVA
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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1 | 0.20 Units on a scale. | Standard Deviation 0.349 |
| Active Cell: Active Mask | Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1 | 0.22 Units on a scale. | Standard Deviation 0.328 |
p-value: <0.00195% CI: [0.11, 0.29]t-test, 2 sided
p-value: <0.00195% CI: [0.13, 0.31]t-test, 2 sided
p-value: 0.5495% CI: [-0.09, 0.16]ANCOVA
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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2 | -0.03 Units on a scale. | Standard Deviation 0.532 |
| Active Cell: Active Mask | Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2 | 0.21 Units on a scale. | Standard Deviation 0.5 |
p-value: 0.62795% CI: [-0.17, 0.1]t-test, 2 sided
p-value: 0.00295% CI: [0.08, 0.34]t-test, 2 sided
p-value: 0.00995% CI: [0.06, 0.42]ANCOVA
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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3 | 0.36 Units on a scale. | Standard Deviation 0.465 |
| Active Cell: Active Mask | Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3 | 0.47 Units on a scale. | Standard Deviation 0.578 |
p-value: <0.00195% CI: [0.23, 0.48]t-test, 2 sided
p-value: <0.00195% CI: [0.32, 0.63]t-test, 2 sided
p-value: 0.22495% CI: [-0.07, 0.3]ANCOVA
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.
Time frame: 1 week
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Fine Lines - Change From Baseline to Week 1 | 0.01 Units on a scale | Standard Deviation 0.132 |
| Active Cell: Active Mask | Fine Lines - Change From Baseline to Week 1 | 0.05 Units on a scale | Standard Deviation 0.16 |
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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Fine Lines - Change From Baseline to Week 12 | 0.23 Units on a Scale | Standard Deviation 0.309 |
| Active Cell: Active Mask | Fine Lines - Change From Baseline to Week 12 | 0.32 Units on a Scale | Standard Deviation 0.358 |
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.
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Fine Lines - Change From Baseline to Week 24 | 0.28 Units on a Scale | Standard Deviation 0.358 |
| Active Cell: Active Mask | Fine Lines - Change From Baseline to Week 24 | 0.29 Units on a Scale | Standard Deviation 0.349 |
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.
Time frame: Baseline to Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Fine Lines - Change From Baseline to Week 4 | 0.08 Units on a Scale | Standard Deviation 0.196 |
| Active Cell: Active Mask | Fine Lines - Change From Baseline to Week 4 | 0.13 Units on a Scale | Standard Deviation 0.205 |
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.
Time frame: Baseline to Week 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Global Wrinkling - Change From Baseline to Week 1 | 0.03 Units on a scale | Standard Deviation 0.158 |
| Active Cell: Active Mask | Global Wrinkling - Change From Baseline to Week 1 | 0.04 Units on a scale | Standard Deviation 0.157 |
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.
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Global Wrinkling - Change From Baseline to Week 24 | 0.24 Units on a scale | Standard Deviation 0.41 |
| Active Cell: Active Mask | Global Wrinkling - Change From Baseline to Week 24 | 0.30 Units on a scale | Standard Deviation 0.378 |
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.
Time frame: Baseline to Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Global Wrinkling - Change From Baseline to Week 4 | 0.09 Units on a scale | Standard Deviation 0.208 |
| Active Cell: Active Mask | Global Wrinkling - Change From Baseline to Week 4 | 0.09 Units on a scale | Standard Deviation 0.198 |
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.
Time frame: Baseline to Week 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Lack of Radiance - Change From Baseline to Week 1 | 0.07 Units on a Scale | Standard Deviation 0.219 |
| Active Cell: Active Mask | Lack of Radiance - Change From Baseline to Week 1 | 0.13 Units on a Scale | Standard Deviation 0.258 |
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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Lack of Radiance - Change From Baseline to Week 12 | 0.41 Units on a Scale | Standard Deviation 0.412 |
| Active Cell: Active Mask | Lack of Radiance - Change From Baseline to Week 12 | 0.55 Units on a Scale | Standard Deviation 0.493 |
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.
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Lack of Radiance - Change From Baseline to Week 24 | 0.54 Units on a Scale | Standard Deviation 0.454 |
| Active Cell: Active Mask | Lack of Radiance - Change From Baseline to Week 24 | 0.59 Units on a Scale | Standard Deviation 0.517 |
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.
Time frame: Baseline to Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Lack of Radiance - Change From Baseline to Week 4 | 0.28 Units on a Scale | Standard Deviation 0.357 |
| Active Cell: Active Mask | Lack of Radiance - Change From Baseline to Week 4 | 0.37 Units on a Scale | Standard Deviation 0.401 |
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.
Time frame: Baseline to Week 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Mottled Hyperpigmentation - Change From Baseline to Week 1 | -0.01 Units on a Scale | Standard Deviation 0.166 |
| Active Cell: Active Mask | Mottled Hyperpigmentation - Change From Baseline to Week 1 | -0.02 Units on a Scale | Standard Deviation 0.174 |
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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Mottled Hyperpigmentation - Change From Baseline to Week 12 | 0.22 Units on a Scale | Standard Deviation 0.456 |
| Active Cell: Active Mask | Mottled Hyperpigmentation - Change From Baseline to Week 12 | 0.39 Units on a Scale | Standard Deviation 0.392 |
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.
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Mottled Hyperpigmentation - Change From Baseline to Week 24 | 0.25 Units on a Scale | Standard Deviation 0.467 |
| Active Cell: Active Mask | Mottled Hyperpigmentation - Change From Baseline to Week 24 | 0.31 Units on a Scale | Standard Deviation 0.401 |
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.
Time frame: Baseline to Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Mottled Hyperpigmentation - Change From Baseline to Week 4 | 0.10 Units on a Scale | Standard Deviation 0.313 |
| Active Cell: Active Mask | Mottled Hyperpigmentation - Change From Baseline to Week 4 | 0.15 Units on a Scale | Standard Deviation 0.288 |
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.
Time frame: Baseline to Week 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Periorbital Wrinkles - Change From Baseline to Week 1 | 0.00 Units on a Scale | Standard Deviation 0.176 |
| Active Cell: Active Mask | Periorbital Wrinkles - Change From Baseline to Week 1 | 0.01 Units on a Scale | Standard Deviation 0.172 |
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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Periorbital Wrinkles - Change From Baseline to Week 12 | 0.15 Units on a Scale | Standard Deviation 0.355 |
| Active Cell: Active Mask | Periorbital Wrinkles - Change From Baseline to Week 12 | 0.30 Units on a Scale | Standard Deviation 0.366 |
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.
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Periorbital Wrinkles - Change From Baseline to Week 24 | 0.22 Units on a Scale | Standard Deviation 0.399 |
| Active Cell: Active Mask | Periorbital Wrinkles - Change From Baseline to Week 24 | 0.29 Units on a Scale | Standard Deviation 0.401 |
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.
Time frame: Baseline to Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Periorbital Wrinkles - Change From Baseline to Week 4 | 0.10 Units on a Scale | Standard Deviation 0.269 |
| Active Cell: Active Mask | Periorbital Wrinkles - Change From Baseline to Week 4 | 0.10 Units on a Scale | Standard Deviation 0.246 |
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.
Time frame: Baseline to Week 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Sallowness/Yellowing - Change From Baseline to Week 1 | -0.01 Units on a Scale | Standard Deviation 0.276 |
| Active Cell: Active Mask | Sallowness/Yellowing - Change From Baseline to Week 1 | 0.01 Units on a Scale | Standard Deviation 0.179 |
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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Sallowness/Yellowing - Change From Baseline to Week 12 | 0.23 Units on a Scale | Standard Deviation 0.39 |
| Active Cell: Active Mask | Sallowness/Yellowing - Change From Baseline to Week 12 | 0.33 Units on a Scale | Standard Deviation 0.496 |
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.
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Sallowness/Yellowing - Change From Baseline to Week 24 | 0.29 Units on a Scale | Standard Deviation 0.445 |
| Active Cell: Active Mask | Sallowness/Yellowing - Change From Baseline to Week 24 | 0.32 Units on a Scale | Standard Deviation 0.504 |
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.
Time frame: Baseline to Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Sallowness/Yellowing - Change From Baseline to Week 4 | 0.12 Units on a Scale | Standard Deviation 0.247 |
| Active Cell: Active Mask | Sallowness/Yellowing - Change From Baseline to Week 4 | 0.12 Units on a Scale | Standard Deviation 0.354 |
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.
Time frame: Baseline to Week 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Surface Roughness - Change From Baseline to Week 1 | 0.35 Units on a Scale | Standard Deviation 0.396 |
| Active Cell: Active Mask | Surface Roughness - Change From Baseline to Week 1 | 0.38 Units on a Scale | Standard Deviation 0.386 |
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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Surface Roughness - Change From Baseline to Week 12 | 0.94 Units on a Scale | Standard Deviation 0.449 |
| Active Cell: Active Mask | Surface Roughness - Change From Baseline to Week 12 | 0.89 Units on a Scale | Standard Deviation 0.576 |
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.
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Surface Roughness - Change From Baseline to Week 24 | 1.12 Units on a Scale | Standard Deviation 0.549 |
| Active Cell: Active Mask | Surface Roughness - Change From Baseline to Week 24 | 0.95 Units on a Scale | Standard Deviation 0.686 |
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.
Time frame: Baseline to Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Surface Roughness - Change From Baseline to Week 4 | 0.79 Units on a Scale | Standard Deviation 0.438 |
| Active Cell: Active Mask | Surface Roughness - Change From Baseline to Week 4 | 0.76 Units on a Scale | Standard Deviation 0.52 |
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.
Time frame: Baseline to Week 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Uneven Skin Tone - Change From Baseline to Week 1 | 0.04 Units on a Scale | Standard Deviation 0.176 |
| Active Cell: Active Mask | Uneven Skin Tone - Change From Baseline to Week 1 | 0.06 Units on a Scale | Standard Deviation 0.119 |
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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Uneven Skin Tone - Change From Baseline to Week 12 | 0.36 Units on a Scale | Standard Deviation 0.388 |
| Active Cell: Active Mask | Uneven Skin Tone - Change From Baseline to Week 12 | 0.49 Units on a Scale | Standard Deviation 0.487 |
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.
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Uneven Skin Tone - Change From Baseline to Week 24 | 0.44 Units on a Scale | Standard Deviation 0.378 |
| Active Cell: Active Mask | Uneven Skin Tone - Change From Baseline to Week 24 | 0.52 Units on a Scale | Standard Deviation 0.499 |
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.
Time frame: Baseline to Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Cell: Sham Mask | Uneven Skin Tone - Change From Baseline to Week 4 | 0.18 Units on a Scale | Standard Deviation 0.282 |
| Active Cell: Active Mask | Uneven Skin Tone - Change From Baseline to Week 4 | 0.23 Units on a Scale | Standard Deviation 0.287 |