Light Emitting Diode (LED) for the Treatment of Wrinkles

RoseLab Skin Optics Laboratory40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Skin Aging Photoaging of Skin

Interventions

Sham lightDEVICE

LumiPhase-R™, OPUSMED Inc. Montreal, CanadaDEVICE

660 nm wavelength delivered in a sequential pulsing mode

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

RoseLab Skin Optics Laboratory

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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.

Data from ClinicalTrials.gov

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