Light Emitting Diode (LED) for the Treatment of Wrinkles

• 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: RoseLab Skin Optics Laboratory
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Sham-treated; LED-treated (Split-face Study)
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

Baseline Characteristics

Arm/Group Title		Sham-treated; LED-treated (Split-face Study)
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
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

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).
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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Sham-treated; LED-treated (Split-face Study)
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)

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.
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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Sham-treated; LED-treated (Split-face Study)
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)

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.
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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Sham-treated; LED-treated (Split-face Study)
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)

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.
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.

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT)

Arm/Group Title	Sham-treated; LED-treated (Split-face Study)
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Sham-treated; LED-treated (Split-face Study)
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	--/--
Serious Adverse Events
	Sham-treated; LED-treated (Split-face Study)
	Affected / at Risk (%)
Total	0/40 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr Daniel Barolet
• Organization: RoseLab Skin Optics Laboratory
• Phone: (514) 343-4444
• EMail: daniel.barolet@mcgill.ca

Publications of Results:

Barolet D, Roberge CJ, Auger FA, Boucher A, Germain L. Regulation of skin collagen metabolism in vitro using a pulsed 660 nm LED light source: clinical correlation with a single-blinded study. J Invest Dermatol. 2009 Dec;129(12):2751-9. doi: 10.1038/jid.2009.186. Epub 2009 Jul 9.

• 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