Light Emitting Diode (LED) for the Treatment of Wrinkles

Study Overview
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Brief Summary
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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.

Official Title
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Non-ablative Light Source for the Treatment of Rhytides (Wrinkles)

Conditions
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Skin Aging, Photoaging of Skin

Intervention / Treatment
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* Device: Sham light
* Device: LumiPhase-R™, OPUSMED Inc. Montreal, Canada


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham light<br>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 | Device: Sham light<br> <br> |
| Experimental: LED-treated<br>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 | Device: LumiPhase-R™, OPUSMED Inc. Montreal, Canada<br>* 660 nm wavelength delivered in a sequential pulsing mode<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. |