Light Emitting Diode (LED) for the Treatment of Wrinkles

Phase 2

Completed

• Conditions: Skin Aging; Photoaging of Skin
• Interventions: Device: Sham light; Device: LumiPhase-R™, OPUSMED Inc. Montreal, Canada

• Registration Number: NCT00818246
• Lead Sponsor: RoseLab Skin Optics Laboratory

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 available

Study Timeline

• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Results First Submitted: 2009-01-07
• Status Verified: 2009-10
• Results First Submitted QC: 2009-10-07
• Last Update Submitted: 2009-10-07
• Results First Posted: 2009-11-16
• Last Update Posted: 2009-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sham light	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
LED-treated	LumiPhase-R™, OPUSMED Inc. Montreal, Canada	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

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).	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.	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

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

Trial Locations

Locations (1)

RoseLab Skin Optics Laboratory; 🇨🇦 Montreal, Quebec, Canada