Light Emitting Diode (LED) for the Treatment of Wrinkles

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

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.

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Detailed Description

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Conditions

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Skin Aging Photoaging of Skin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sham light

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

Group Type SHAM_COMPARATOR

Sham light

Intervention Type DEVICE

LED-treated

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

Group Type EXPERIMENTAL

LumiPhase-R™, OPUSMED Inc. Montreal, Canada

Intervention Type DEVICE

660 nm wavelength delivered in a sequential pulsing mode

Interventions

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Sham light

Intervention Type DEVICE

LumiPhase-R™, OPUSMED Inc. Montreal, Canada

660 nm wavelength delivered in a sequential pulsing mode

Intervention Type DEVICE

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes