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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham light | Sham Comparator | one side of the face was treated three times weekly for four consecutive weeks (12 treatments) with a Sham light on the experimental periorbital area |
|
| LED-treated | Experimental | one side of the face was treated three times weekly for four consecutive weeks (12 treatments) with 660 nm Light emitting diode (LED) on the experimental periorbital area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham light | Device |
| ||
| LumiPhase-Râ„¢, OPUSMED Inc. Montreal, Canada |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 4 weeks |
| 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. | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RoseLab Skin Optics Laboratory | Montreal | Quebec | H3R 3L5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19587693 | Result | Barolet D, Roberge CJ, Auger FA, Boucher A, Germain L. Regulation of skin collagen metabolism in vitro using a pulsed 660 nm LED light source: clinical correlation with a single-blinded study. J Invest Dermatol. 2009 Dec;129(12):2751-9. doi: 10.1038/jid.2009.186. Epub 2009 Jul 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Per Protocol | Posted | Mean | 95% Confidence Interval | Percent change post-treatment | Baseline and 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham-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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Daniel Barolet | RoseLab Skin Optics Laboratory | (514) 343-4444 | daniel.barolet@mcgill.ca |
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| Device |
660 nm wavelength delivered in a sequential pulsing mode |
|
| Baseline and 4 weeks |
| Number of Adverse Events. | Signs of erythema, edema, scaling/crusting, bronzing, textural changes, hyperpigmentation, and hypopigmentation were monitored. | Adverse reactions were monitored throughout the study and up to 4 weeks. |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| 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. | Per Protocol | Posted | Mean | 95% Confidence Interval | Change in units on the FCS scale | Baseline and 4 weeks |
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| 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. | Per Protocol | Posted | Mean | 95% Confidence Interval | Percent change post-treatment | Baseline and 4 weeks |
|
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| Secondary | Number of Adverse Events. | Signs of erythema, edema, scaling/crusting, bronzing, textural changes, hyperpigmentation, and hypopigmentation were monitored. | Intention to treat (ITT) | Posted | Number | Number of adverse events | Adverse reactions were monitored throughout the study and up to 4 weeks. |
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| 0 |
| 40 |
| 0 |
| 40 |
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| Superiority or Other |