Photoaging of Skin, Skin Aging
Conditions
Brief summary
The purpose of this study was to determine whether light emitting diode (LED) therapy can improve skin appearance of human subjects with aged/photoaged skin. A reduction in rhytid depth as well as in skin surface roughness and in the degree of elastosis after LED treatments was expected.
Interventions
DEVICESham light
DEVICELumiPhase-R™, OPUSMED Inc. Montreal, Canada
660 nm wavelength delivered in a sequential pulsing mode
Sponsors
RoseLab Skin Optics Laboratory
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* subjects with aged/photodamaged skin
Exclusion criteria
* Subjects were not allowed to participate in this study if they were taking cortisone (Prednisone), anticoagulant therapy, or any drug known to increase photosensitivity. In addition, during the 12 months preceding the study, subjects were required not to have used isotretinoin (Accutane), or applied topical steroids to the site to be treated. Moreover, previous laser or topical medication at the to-be-treated site was not permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness). | Baseline and 4 weeks | Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Ra values (skin surface roughness). |
| Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity. | Baseline and 4 weeks | Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Rz values (peak to valley analysis) to quantify rhytid depth and severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling. | Baseline and 4 weeks | Clinical qualitative assessment was performed by three blinded medical observers through the evaluation of digital photographs. The photographs were analyzed for clinical improvement using the Fitzpatrick Classification System (FCS)subtype scale for degree of wrinkling (rhytids). Their assessment was rated on a five-point scale and scored as follows; 0=none; 1=mild; 2=moderate; 3=good; 4=excellent. |
| Number of Adverse Events. | Adverse reactions were monitored throughout the study and up to 4 weeks. | Signs of erythema, edema, scaling/crusting, bronzing, textural changes, hyperpigmentation, and hypopigmentation were monitored. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham-treated; LED-treated (Split-face Study) one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Impossible to match pictures | 5 |
Baseline characteristics
| Characteristic | Sham-treated; LED-treated (Split-face Study) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age Continuous | 45 years STANDARD_DEVIATION 7 |
| Region of Enrollment Canada | 40 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).
Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Ra values (skin surface roughness).
Time frame: Baseline and 4 weeks
Population: Per Protocol
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sham-treated; LED-treated (Split-face Study) | Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness). | Sham-treated | 3.62 Percent change post-treatment |
| Sham-treated; LED-treated (Split-face Study) | Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness). | LED-treated | 18.57 Percent change post-treatment |
Comparison: Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.p-value: <0.0001ANCOVA
Primary
Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity.
Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Rz values (peak to valley analysis) to quantify rhytid depth and severity.
Time frame: Baseline and 4 weeks
Population: Per Protocol
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sham-treated; LED-treated (Split-face Study) | Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity. | Sham-treated | 7.34 Percent change post-treatment |
| Sham-treated; LED-treated (Split-face Study) | Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity. | LED-treated | 20.82 Percent change post-treatment |
Comparison: Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.
Clinical qualitative assessment was performed by three blinded medical observers through the evaluation of digital photographs. The photographs were analyzed for clinical improvement using the Fitzpatrick Classification System (FCS)subtype scale for degree of wrinkling (rhytids). Their assessment was rated on a five-point scale and scored as follows; 0=none; 1=mild; 2=moderate; 3=good; 4=excellent.
Time frame: Baseline and 4 weeks
Population: Per Protocol
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sham-treated; LED-treated (Split-face Study) | Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling. | Sham-treated | 0.48 Change in units on the FCS scale |
| Sham-treated; LED-treated (Split-face Study) | Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling. | LED-treated | 1.08 Change in units on the FCS scale |
p-value: <0.001ANCOVA
Secondary
Number of Adverse Events.
Signs of erythema, edema, scaling/crusting, bronzing, textural changes, hyperpigmentation, and hypopigmentation were monitored.
Time frame: Adverse reactions were monitored throughout the study and up to 4 weeks.
Population: Intention to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sham-treated; LED-treated (Split-face Study) | Number of Adverse Events. | Sham-treated | 0 Number of adverse events |
| Sham-treated; LED-treated (Split-face Study) | Number of Adverse Events. | LED-treated | 0 Number of adverse events |