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Light Emitting Diode (LED) for the Treatment of Wrinkles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00818246
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : November 16, 2009
Last Update Posted : November 16, 2009
Sponsor:
Information provided by:
RoseLab Skin Optics Laboratory

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Skin Aging Photoaging of Skin Device: Sham light Device: LumiPhase-R™, OPUSMED Inc. Montreal, Canada Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-ablative Light Source for the Treatment of Rhytides (Wrinkles)
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818246


Locations
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Canada, Quebec
RoseLab Skin Optics Laboratory
Montreal, Quebec, Canada, H3R 3L5
Sponsors and Collaborators
RoseLab Skin Optics Laboratory
More Information
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Publications of Results:

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Responsible Party: Dr Daniel Barolet, RoseLab Skin Optics Laboratory
ClinicalTrials.gov Identifier: NCT00818246    
Other Study ID Numbers: LEDP-1
First Posted: January 7, 2009    Key Record Dates
Results First Posted: November 16, 2009
Last Update Posted: November 16, 2009
Last Verified: October 2009