Light Emitting Diode (LED) for the Treatment of Wrinkles

October 7, 2009 updated by: RoseLab Skin Optics Laboratory

Non-ablative Light Source for the Treatment of Rhytides (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3R 3L5
        • RoseLab Skin Optics Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 4 weeks
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.
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.
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.
Baseline and 4 weeks
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.
Adverse reactions were monitored throughout the study and up to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RoseLab Skin Optics Laboratory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

November 16, 2009

Last Update Submitted That Met QC Criteria

October 7, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • LEDP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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