Light Emitting Diode (LED) for the Treatment of Wrinkles

NCT00818246 | Completed Phase 2 Results

• 1 other identifier: LEDP-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging; Photoaging of Skin

Outcome Measures

Primary Outcomes (2)

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

  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.

  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 Outcomes (2)

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

  Baseline and 4 weeks

• Number of Adverse Events.

  Adverse reactions were monitored throughout the study and up to 4 weeks.

Study Arms (2)

Sham light

SHAM COMPARATOR

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

LED-treated

EXPERIMENTAL

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

Interventions

Sham light DEVICE

Sham light

LumiPhase-R™, OPUSMED Inc. Montreal, Canada DEVICE

660 nm wavelength delivered in a sequential pulsing mode

LED-treated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects with aged/photodamaged skin

You may not qualify if:

• 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.

Sponsors & Collaborators

• RoseLab Skin Optics Laboratory: lead

Study Sites (1)

RoseLab Skin Optics Laboratory

Montreal, Quebec, H3R 3L5, Canada

Location

Related Publications (1)

• 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.

  PMID: 19587693 RESULT

Results Point of Contact

• Title: Dr Daniel Barolet
• Organization: RoseLab Skin Optics Laboratory

daniel.barolet@mcgill.ca

(514) 343-4444

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: January 7, 2009
• Last Updated: November 16, 2009
• Results First Posted: November 16, 2009

Record last verified: 2009-10

Locations

CA (1)