MedTrace Logo

Trial Outcomes & Findings for Evaluation of the Efficacy and Tolerance of a Light Therapy Mask on Mild to Moderate Brown Spots and Moderate to Severe Facial Wrinkles (NCT NCT03312543)

NCT ID: NCT03312543

Last Updated: 2019-03-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

124 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2019-03-05

Participant Flow

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).

Participant milestones

Participant milestones
Measure
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.
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.
Before Treatment (Screening to Baseline)
STARTED
61
63
Before Treatment (Screening to Baseline)
COMPLETED
60
59
Before Treatment (Screening to Baseline)
NOT COMPLETED
1
4
Treatment (Baseline to Week 12)
STARTED
60
59
Treatment (Baseline to Week 12)
COMPLETED
56
54
Treatment (Baseline to Week 12)
NOT COMPLETED
4
5
Regression (Week 12 to Week 24)
STARTED
56
54
Regression (Week 12 to Week 24)
COMPLETED
55
52
Regression (Week 12 to Week 24)
NOT COMPLETED
1
2

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Before Treatment (Screening to Baseline)
Lost to Follow-up
0
2
Before Treatment (Screening to Baseline)
Withdrawal by Subject
1
2
Treatment (Baseline to Week 12)
Withdrawal by Subject
3
4
Treatment (Baseline to Week 12)
Protocol Violation
1
1
Regression (Week 12 to Week 24)
Protocol Violation
1
1
Regression (Week 12 to Week 24)
Death
0
1

Baseline Characteristics

Evaluation of the Efficacy and Tolerance of a Light Therapy Mask on Mild to Moderate Brown Spots and Moderate to Severe Facial Wrinkles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sham Cell: Sham Mask
n=61 Participants
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.
Active Cell: Active Mask
n=63 Participants
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.
Total
n=124 Participants
Total of all reporting groups
Age, Continuous
56.3 Years
STANDARD_DEVIATION 8.02 • n=99 Participants
56.6 Years
STANDARD_DEVIATION 7.34 • n=107 Participants
56.5 Years
STANDARD_DEVIATION 7.65 • n=206 Participants
Sex: Female, Male
Female
61 Participants
n=99 Participants
63 Participants
n=107 Participants
124 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
60 Participants
n=99 Participants
62 Participants
n=107 Participants
122 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
15 Participants
n=99 Participants
18 Participants
n=107 Participants
33 Participants
n=206 Participants
Race (NIH/OMB)
White
45 Participants
n=99 Participants
45 Participants
n=107 Participants
90 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Fitzpatrick Skin Type
I
11 Participants
n=99 Participants
11 Participants
n=107 Participants
22 Participants
n=206 Participants
Fitzpatrick Skin Type
II
11 Participants
n=99 Participants
11 Participants
n=107 Participants
22 Participants
n=206 Participants
Fitzpatrick Skin Type
III
9 Participants
n=99 Participants
11 Participants
n=107 Participants
20 Participants
n=206 Participants
Fitzpatrick Skin Type
IV
10 Participants
n=99 Participants
11 Participants
n=107 Participants
21 Participants
n=206 Participants
Fitzpatrick Skin Type
V
10 Participants
n=99 Participants
9 Participants
n=107 Participants
19 Participants
n=206 Participants
Fitzpatrick Skin Type
VI
10 Participants
n=99 Participants
10 Participants
n=107 Participants
20 Participants
n=206 Participants
Skin Oiliness Level
Oily
2 Participants
n=99 Participants
4 Participants
n=107 Participants
6 Participants
n=206 Participants
Skin Oiliness Level
Dry
9 Participants
n=99 Participants
13 Participants
n=107 Participants
22 Participants
n=206 Participants
Skin Oiliness Level
Normal
23 Participants
n=99 Participants
17 Participants
n=107 Participants
40 Participants
n=206 Participants
Skin Oiliness Level
Combination
27 Participants
n=99 Participants
29 Participants
n=107 Participants
56 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores
0.18 Units on a scale
Standard Deviation 0.328
0.30 Units on a scale
Standard Deviation 0.341

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
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
0.22 Units on a scale.
Standard Deviation 0.328

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
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
0.21 Units on a scale.
Standard Deviation 0.500

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
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
0.47 Units on a scale.
Standard Deviation 0.578

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
Global Wrinkling - Change From Baseline to Week 1
0.03 Units on a scale
Standard Deviation 0.158
0.04 Units on a scale
Standard Deviation 0.157

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=56 Participants
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.
Global Wrinkling - Change From Baseline to Week 4
0.09 Units on a scale
Standard Deviation 0.208
0.09 Units on a scale
Standard Deviation 0.198

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=55 Participants
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.
Active Cell: Active Mask
n=52 Participants
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.
Global Wrinkling - Change From Baseline to Week 24
0.24 Units on a scale
Standard Deviation 0.410
0.30 Units on a scale
Standard Deviation 0.378

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
Fine Lines - Change From Baseline to Week 1
0.01 Units on a scale
Standard Deviation 0.132
0.05 Units on a scale
Standard Deviation 0.160

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=56 Participants
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.
Fine Lines - Change From Baseline to Week 4
0.08 Units on a Scale
Standard Deviation 0.196
0.13 Units on a Scale
Standard Deviation 0.205

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=54 Participants
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.
Fine Lines - Change From Baseline to Week 12
0.23 Units on a Scale
Standard Deviation 0.309
0.32 Units on a Scale
Standard Deviation 0.358

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=55 Participants
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.
Active Cell: Active Mask
n=52 Participants
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.
Fine Lines - Change From Baseline to Week 24
0.28 Units on a Scale
Standard Deviation 0.358
0.29 Units on a Scale
Standard Deviation 0.349

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
Periorbital Wrinkles - Change From Baseline to Week 1
0.00 Units on a Scale
Standard Deviation 0.176
0.01 Units on a Scale
Standard Deviation 0.172

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=56 Participants
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.
Periorbital Wrinkles - Change From Baseline to Week 4
0.10 Units on a Scale
Standard Deviation 0.269
0.10 Units on a Scale
Standard Deviation 0.246

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=64 Participants
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.
Periorbital Wrinkles - Change From Baseline to Week 12
0.15 Units on a Scale
Standard Deviation 0.355
0.30 Units on a Scale
Standard Deviation 0.366

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=55 Participants
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.
Active Cell: Active Mask
n=52 Participants
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.
Periorbital Wrinkles - Change From Baseline to Week 24
0.22 Units on a Scale
Standard Deviation 0.399
0.29 Units on a Scale
Standard Deviation 0.401

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
Surface Roughness - Change From Baseline to Week 1
0.35 Units on a Scale
Standard Deviation 0.396
0.38 Units on a Scale
Standard Deviation 0.386

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=56 Participants
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.
Surface Roughness - Change From Baseline to Week 4
0.79 Units on a Scale
Standard Deviation 0.438
0.76 Units on a Scale
Standard Deviation 0.520

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=54 Participants
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.
Surface Roughness - Change From Baseline to Week 12
0.94 Units on a Scale
Standard Deviation 0.449
0.89 Units on a Scale
Standard Deviation 0.576

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=55 Participants
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.
Active Cell: Active Mask
n=52 Participants
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.
Surface Roughness - Change From Baseline to Week 24
1.12 Units on a Scale
Standard Deviation 0.549
0.95 Units on a Scale
Standard Deviation 0.686

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
Uneven Skin Tone - Change From Baseline to Week 1
0.04 Units on a Scale
Standard Deviation 0.176
0.06 Units on a Scale
Standard Deviation 0.119

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=56 Participants
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.
Uneven Skin Tone - Change From Baseline to Week 4
0.18 Units on a Scale
Standard Deviation 0.282
0.23 Units on a Scale
Standard Deviation 0.287

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=54 Participants
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.
Uneven Skin Tone - Change From Baseline to Week 12
0.36 Units on a Scale
Standard Deviation 0.388
0.49 Units on a Scale
Standard Deviation 0.487

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=55 Participants
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.
Active Cell: Active Mask
n=52 Participants
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.
Uneven Skin Tone - Change From Baseline to Week 24
0.44 Units on a Scale
Standard Deviation 0.378
0.52 Units on a Scale
Standard Deviation 0.499

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
Mottled Hyperpigmentation - Change From Baseline to Week 1
-0.01 Units on a Scale
Standard Deviation 0.166
-0.02 Units on a Scale
Standard Deviation 0.174

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=56 Participants
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.
Mottled Hyperpigmentation - Change From Baseline to Week 4
0.10 Units on a Scale
Standard Deviation 0.313
0.15 Units on a Scale
Standard Deviation 0.288

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=54 Participants
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.
Mottled Hyperpigmentation - Change From Baseline to Week 12
0.22 Units on a Scale
Standard Deviation 0.456
0.39 Units on a Scale
Standard Deviation 0.392

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=55 Participants
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.
Active Cell: Active Mask
n=52 Participants
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.
Mottled Hyperpigmentation - Change From Baseline to Week 24
0.25 Units on a Scale
Standard Deviation 0.467
0.31 Units on a Scale
Standard Deviation 0.401

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
Sallowness/Yellowing - Change From Baseline to Week 1
-0.01 Units on a Scale
Standard Deviation 0.276
0.01 Units on a Scale
Standard Deviation 0.179

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=56 Participants
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.
Sallowness/Yellowing - Change From Baseline to Week 4
0.12 Units on a Scale
Standard Deviation 0.247
0.12 Units on a Scale
Standard Deviation 0.354

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=54 Participants
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.
Sallowness/Yellowing - Change From Baseline to Week 12
0.23 Units on a Scale
Standard Deviation 0.390
0.33 Units on a Scale
Standard Deviation 0.496

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=55 Participants
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.
Active Cell: Active Mask
n=52 Participants
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.
Sallowness/Yellowing - Change From Baseline to Week 24
0.29 Units on a Scale
Standard Deviation 0.445
0.32 Units on a Scale
Standard Deviation 0.504

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=59 Participants
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.
Active Cell: Active Mask
n=57 Participants
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.
Lack of Radiance - Change From Baseline to Week 1
0.07 Units on a Scale
Standard Deviation 0.219
0.13 Units on a Scale
Standard Deviation 0.258

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=56 Participants
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.
Lack of Radiance - Change From Baseline to Week 4
0.28 Units on a Scale
Standard Deviation 0.357
0.37 Units on a Scale
Standard Deviation 0.401

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=56 Participants
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.
Active Cell: Active Mask
n=54 Participants
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.
Lack of Radiance - Change From Baseline to Week 12
0.41 Units on a Scale
Standard Deviation 0.412
0.55 Units on a Scale
Standard Deviation 0.493

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Sham Cell: Sham Mask
n=55 Participants
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.
Active Cell: Active Mask
n=52 Participants
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.
Lack of Radiance - Change From Baseline to Week 24
0.54 Units on a Scale
Standard Deviation 0.454
0.59 Units on a Scale
Standard Deviation 0.517

Adverse Events

Sham Cell: Sham Mask

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Active Cell: Active Mask

Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Sham Cell: Sham Mask
n=60 participants at risk
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.
Active Cell: Active Mask
n=59 participants at risk
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.
General disorders
Sudden Death
0.00%
0/60 • 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).
1.7%
1/59 • Number of events 1 • 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).

Other adverse events

Other adverse events
Measure
Sham Cell: Sham Mask
n=60 participants at risk
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.
Active Cell: Active Mask
n=59 participants at risk
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.
Infections and infestations
Upper Respiratory Tract Infection
1.7%
1/60 • Number of events 1 • 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).
8.5%
5/59 • Number of events 5 • 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).
Infections and infestations
Oral Herpes
5.0%
3/60 • Number of events 3 • 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).
0.00%
0/59 • 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).

Additional Information

Sidney Hornby

Johnson & Johnson Consumer Inc.

Phone: 908-874-2756

Results disclosure agreements

  • Principal investigator is a sponsor employee PI must provide Sponsor 60 days to review any publication (unless expedited review requested); if it includes Sponsor's confidential info, written Sponsor approval is required. Sponsor may require another 60 days' delay to file a patent application.
  • Publication restrictions are in place

Restriction type: OTHER