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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00818246
Other study ID # LEDP-1
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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