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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

Tracking Information
First Submitted Date  ICMJE December 3, 2008
First Posted Date  ICMJE January 7, 2009
Results First Submitted Date  ICMJE January 7, 2009
Results First Posted Date  ICMJE November 16, 2009
Last Update Posted Date November 16, 2009
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2009)
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
Microtopographic profilometry Ra value (skin roughness)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2009)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
  • Improvement in at least one Fitzpatrick Classification System (FCS) for degree of elastosis
  • Monitoring of adverse events
  • Microtopographic profilometry Rz value (rhytid)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Light Emitting Diode (LED) for the Treatment of Wrinkles
Official Title  ICMJE Non-ablative Light Source for the Treatment of Rhytides (Wrinkles)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Aging
  • Photoaging of Skin
Intervention  ICMJE
  • Device: Sham light
  • Device: LumiPhase-R™, OPUSMED Inc. Montreal, Canada
    660 nm wavelength delivered in a sequential pulsing mode
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Device: LumiPhase-R™, OPUSMED Inc. Montreal, Canada
Publications * Barolet D, Roberge CJ, Auger FA, Boucher A, Germain L. Regulation of skin collagen metabolism in vitro using a pulsed 660 nm LED light source: clinical correlation with a single-blinded study. J Invest Dermatol. 2009 Dec;129(12):2751-9. doi: 10.1038/jid.2009.186. Epub 2009 Jul 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2009)
40
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00818246
Other Study ID Numbers  ICMJE LEDP-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Daniel Barolet, RoseLab Skin Optics Laboratory
Study Sponsor  ICMJE RoseLab Skin Optics Laboratory
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account RoseLab Skin Optics Laboratory
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP