Non-ablative Light Source for the Treatment of Rhytides (Wrinkles)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.(Baseline and 4 weeks)
- Number of Adverse Events.(Adverse reactions were monitored throughout the study and up to 4 weeks.)