Light Emitting Diode (LED) for the Treatment of Wrinkles

This study has been completed.
Sponsor:
Information provided by:
RoseLab Skin Optics Laboratory
ClinicalTrials.gov Identifier:
NCT00818246
First received: December 3, 2008
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-ablative Light Source for the Treatment of Rhytides (Wrinkles)

Resource links provided by NLM:


Further study details as provided by RoseLab Skin Optics Laboratory:

Primary Outcome Measures:
  • Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness). [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity. [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling. [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Number of Adverse Events. [ Time Frame: Adverse reactions were monitored throughout the study and up to 4 weeks. ] [ Designated as safety issue: Yes ]

Enrollment: 40
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818246

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

Publications:
Responsible Party: Dr Daniel Barolet, RoseLab Skin Optics Laboratory
ClinicalTrials.gov Identifier: NCT00818246     History of Changes
Other Study ID Numbers: LEDP-1
Study First Received: December 3, 2008
Results First Received: January 7, 2009
Last Updated: October 7, 2009
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on April 23, 2014