Light Emitting Diode (LED) for the Treatment of Wrinkles

Skin Aging Clinical Trial

Official title:

Non-ablative Light Source for the Treatment of Rhytides (Wrinkles)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818246
• Other study ID #: LEDP-1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 3, 2008
• Last updated: October 7, 2009

Study information

• Verified date: October 2009
• Source: RoseLab Skin Optics Laboratory
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Photoaging of Skin
• Skin Aging

Intervention

Device:
• Sham light

• LumiPhase-R™, OPUSMED Inc. Montreal, Canada
660 nm wavelength delivered in a sequential pulsing mode

Locations

Country	Name	City	State
Canada	RoseLab Skin Optics Laboratory	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
RoseLab Skin Optics Laboratory

Country where clinical trial is conducted

Canada, 

References & 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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).		Baseline and 4 weeks	No
Primary	Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity.		Baseline and 4 weeks	No
Secondary	Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.		Baseline and 4 weeks	No
Secondary	Number of Adverse Events.		Adverse reactions were monitored throughout the study and up to 4 weeks.	Yes