- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00818246
Light Emitting Diode (LED) for the Treatment of Wrinkles
October 7, 2009 updated by: RoseLab Skin Optics Laboratory
Non-ablative Light Source for the Treatment of Rhytides (Wrinkles)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3R 3L5
- RoseLab Skin Optics Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
|
Experimental: LED-treated
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
|
660 nm wavelength delivered in a sequential pulsing mode
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline and 4 weeks
|
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.
|
Baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 4 weeks
|
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.
|
Adverse reactions were monitored throughout the study and up to 4 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
December 3, 2008
First Submitted That Met QC Criteria
January 6, 2009
First Posted (Estimate)
January 7, 2009
Study Record Updates
Last Update Posted (Estimate)
November 16, 2009
Last Update Submitted That Met QC Criteria
October 7, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- LEDP-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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