Phase 3
N=40
Light Emitting Diode (LED) for the Treatment of Wrinkles
Skin Aging · Photoaging of Skin
Bottom Line
View on ClinicalTrials.gov: NCT00818246 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcome: Primary: Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness). — 3.62; 18.57 Percent change post-treatment — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sham light (Device); LumiPhase-R™, OPUSMED Inc. Montreal, Canada (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- RoseLab Skin Optics Laboratory
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness). |
3.62; 18.57 | <0.0001 sig |
| PRIMARY Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity. |
7.34; 20.82 | <0.0001 sig |
| SECONDARY Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling. |
0.48; 1.08 | <0.001 sig |
| SECONDARY Number of Adverse Events. |
0; 0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00818246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.