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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
Sponsor:
Information provided by:
RoseLab Skin Optics Laboratory

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Skin Aging
Photoaging of Skin
Interventions Device: Sham light
Device: LumiPhase-R™, OPUSMED Inc. Montreal, Canada
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sham-treated; LED-treated (Split-face Study)
Hide Arm/Group Description one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
Period Title: Overall Study
Started 40
Completed 35 [1]
Not Completed 5
Reason Not Completed
Impossible to match pictures             5
[1]
split-face study
Arm/Group Title Sham-treated; LED-treated (Split-face Study)
Hide Arm/Group Description one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
45  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
37
  92.5%
Male
3
   7.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 40 participants
40
1.Primary Outcome
Title Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).
Hide Description 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).
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Sham-treated; LED-treated (Split-face Study)
Hide Arm/Group Description:
one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
Overall Number of Participants Analyzed 35
Mean (95% Confidence Interval)
Unit of Measure: Percent change post-treatment
Sham-treated
3.62
(-0.16 to 7.41)
LED-treated
18.57
(14.78 to 22.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham-treated; LED-treated (Split-face Study)
Comments Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.94
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.68
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity.
Hide Description 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.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Sham-treated; LED-treated (Split-face Study)
Hide Arm/Group Description:
one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
Overall Number of Participants Analyzed 35
Mean (95% Confidence Interval)
Unit of Measure: Percent change post-treatment
Sham-treated
7.34
(3.37 to 11.31)
LED-treated
20.82
(16.85 to 24.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham-treated; LED-treated (Split-face Study)
Comments Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.
Hide Description 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.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Sham-treated; LED-treated (Split-face Study)
Hide Arm/Group Description:
one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
Overall Number of Participants Analyzed 40
Mean (95% Confidence Interval)
Unit of Measure: Change in units on the FCS scale
Sham-treated
0.48
(0.35 to 0.61)
LED-treated
1.08
(0.96 to 1.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham-treated; LED-treated (Split-face Study)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.605
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Adverse Events.
Hide Description Signs of erythema, edema, scaling/crusting, bronzing, textural changes, hyperpigmentation, and hypopigmentation were monitored.
Time Frame Adverse reactions were monitored throughout the study and up to 4 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Sham-treated; LED-treated (Split-face Study)
Hide Arm/Group Description:
one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Number of adverse events
Sham-treated 0
LED-treated 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham-treated; LED-treated (Split-face Study)
Hide Arm/Group Description one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
All-Cause Mortality
Sham-treated; LED-treated (Split-face Study)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Sham-treated; LED-treated (Split-face Study)
Affected / at Risk (%)
Total   0/40 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham-treated; LED-treated (Split-face Study)
Affected / at Risk (%)
Total   0/40 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Daniel Barolet
Organization: RoseLab Skin Optics Laboratory
Phone: (514) 343-4444
EMail: daniel.barolet@mcgill.ca
Layout table for additonal information
Responsible Party: Dr Daniel Barolet, RoseLab Skin Optics Laboratory
ClinicalTrials.gov Identifier: NCT00818246    
Other Study ID Numbers: LEDP-1
First Submitted: December 3, 2008
First Posted: January 7, 2009
Results First Submitted: January 7, 2009
Results First Posted: November 16, 2009
Last Update Posted: November 16, 2009