Light Emitting Diode (LED) for the Treatment of Wrinkles
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|ClinicalTrials.gov Identifier: NCT00818246|
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : November 16, 2009
Last Update Posted : November 16, 2009
|Condition or disease||Intervention/treatment||Phase|
|Skin Aging Photoaging of Skin||Device: Sham light Device: LumiPhase-R™, OPUSMED Inc. Montreal, Canada||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Non-ablative Light Source for the Treatment of Rhytides (Wrinkles)|
Sham Comparator: 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
Device: Sham light
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
660 nm wavelength delivered in a sequential pulsing mode
- Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness). [ Time Frame: 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. [ Time Frame: 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.
- Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling. [ Time Frame: 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818246
|RoseLab Skin Optics Laboratory|
|Montreal, Quebec, Canada, H3R 3L5|