Trial Outcomes & Findings for Light Emitting Diode (LED) for the Treatment of Wrinkles (NCT NCT00818246)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

40 participants

Primary outcome timeframe

Baseline and 4 weeks

Results posted on

2009-11-16

Participant Flow

Participant milestones

Participant milestones
Measure	Sham-treated; LED-treated (Split-face Study) 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 Study STARTED	40
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Sham-treated; LED-treated (Split-face Study) 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 Study Impossible to match pictures	5

Baseline Characteristics

Light Emitting Diode (LED) for the Treatment of Wrinkles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham-treated; LED-treated (Split-face Study) n=40 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	45 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Canada	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Population: Per Protocol

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).

Outcome measures

Outcome measures
Measure	Sham-treated; LED-treated (Split-face Study) n=35 Participants 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.
Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness). Sham-treated	3.62 Percent change post-treatment Interval -0.16 to 7.41
Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness). LED-treated	18.57 Percent change post-treatment Interval 14.78 to 22.36

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	Sham-treated; LED-treated (Split-face Study) n=35 Participants 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.
Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity. Sham-treated	7.34 Percent change post-treatment Interval 3.37 to 11.31
Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity. LED-treated	20.82 Percent change post-treatment Interval 16.85 to 24.79

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	Sham-treated; LED-treated (Split-face Study) n=40 Participants 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.
Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling. Sham-treated	0.48 Change in units on the FCS scale Interval 0.35 to 0.61
Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling. LED-treated	1.08 Change in units on the FCS scale Interval 0.96 to 1.21

SECONDARY outcome

Timeframe: Adverse reactions were monitored throughout the study and up to 4 weeks.

Population: Intention to treat (ITT)

Signs of erythema, edema, scaling/crusting, bronzing, textural changes, hyperpigmentation, and hypopigmentation were monitored.

Outcome measures

Outcome measures
Measure	Sham-treated; LED-treated (Split-face Study) n=40 Participants 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.
Number of Adverse Events. Sham-treated	0 Number of adverse events
Number of Adverse Events. LED-treated	0 Number of adverse events

Adverse Events

Sham-treated; LED-treated (Split-face Study)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Daniel Barolet

RoseLab Skin Optics Laboratory

Phone: (514) 343-4444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place