Skip to main content
OpenTrials
Completed

NCT Number: NCT00818246

Light Emitting Diode (LED) for the Treatment of Wrinkles

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Aging Photoaging of Skin

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

RoseLab Skin Optics Laboratory

Montreal, Quebec, H3R 3L5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sham light

Device

LumiPhase-R™, OPUSMED Inc. Montreal, Canada

Device

660 nm wavelength delivered in a sequential pulsing mode

Primary outcomes

  1. Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).

    Time frame: 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).

  2. Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity.

    Time frame: 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 outcomes

  1. Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.

    Time frame: 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.

  2. Number of Adverse Events.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

RoseLab Skin Optics Laboratory

Other

Registry information

Official study title

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

Important dates

First posted
Jan 7, 2009
Registry last updated
Nov 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.