Skin AgingPhase 2/3NCT00818246

Light Emitting Diode (LED) for the Treatment of Wrinkles

A Phase 2/3 study testing LumiPhase-R™, OPUSMED Inc. Montreal, Canada in people with Skin Aging and Photoaging of Skin, run by RoseLab Skin Optics Laboratory at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Skin Aging, Photoaging of Skin
What is being tested?: LumiPhase-R™, OPUSMED Inc. Montreal, Canada
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteCanada
Study dates: Start not givento not given
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

subjects with aged/photodamaged skin

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

RoseLab Skin Optics Laboratory
Montreal, Quebec, H3R 3L5

Other trials in Canada

About this study

Official title: Non-ablative Light Source for the Treatment of Rhytides (Wrinkles)

Conditions: Skin Aging, Photoaging of Skin
Being tested: Sham light, LumiPhase-R™, OPUSMED Inc. Montreal, Canada

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sham lightDevice
LumiPhase-R™, OPUSMED Inc. Montreal, CanadaDevice
660 nm wavelength delivered in a sequential pulsing mode

Study groups in NCT00818246
Study group	Role	What they receive
Sham light	Sham comparator	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 Receives: Device: Sham light
LED-treated	Experimental	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 Receives: Device: LumiPhase-R™, OPUSMED Inc. Montreal, Canada

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).
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).
Measured: Baseline and 4 weeks
Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity.
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.
Measured: Baseline and 4 weeks

Secondary outcomes (2)

Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.
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.
Measured: Baseline and 4 weeks
Number of Adverse Events.
Signs of erythema, edema, scaling/crusting, bronzing, textural changes, hyperpigmentation, and hypopigmentation were monitored.
Measured: Adverse reactions were monitored throughout the study and up to 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

First posted7 Jan 2009 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Skin AgingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00818246
Sponsor's protocol ID: LEDP-1
Status last verified: Oct 2009
First submitted: 3 Dec 2008
Last updated: 16 Nov 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19587693

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-ablative Light Source for the Treatment of Rhytides (Wrinkles)
ClinicalTrials.gov ID: NCT00818246
Acronym / sponsor ID: LEDP-1
Conditions: Skin Aging, Photoaging of Skin
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: RoseLab Skin Optics LaboratoryUniversity, hospital or other
First posted: 7 Jan 2009 (estimated)
Results: Posted 16 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sham light	Sham comparator	Device: Sham lightone side of the face was treated three times weekly for four consecutive weeks (12 treatments) with a Sham light on the experimental periorbital area
LED-treated	Experimental	Device: LumiPhase-R™, OPUSMED Inc. Montreal, Canadaone 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

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

subjects with aged/photodamaged skin

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sham light	Device	Sham light
LumiPhase-R™, OPUSMED Inc. Montreal, Canada660 nm wavelength delivered in a sequential pulsing mode	Device	LED-treated

Primary outcome

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.

2 secondary outcomes

Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.
Time frame: Baseline and 4 weeks
Number of Adverse Events.
Time frame: Adverse reactions were monitored throughout the study and up to 4 weeks.

Results and safety

Results posted to the registry on 16 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham-treated; LED-treated (Split-face Study)	40	35

Primary outcome: Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).

Time frame: Baseline and 4 weeks. Mean (95% Confidence Interval). Unit: Percent change post-treatment

Measure	Sham-treated; LED-treated (Split-face Study) n = 35
Sham-treated	3.62 (-0.16 to 7.41)
LED-treated	18.57 (14.78 to 22.36)

Sham-treated; LED-treated (Split-face Study): Mean Difference (Final Values): 14.94, p <0.0001, ANCOVA

Population analysed: Per Protocol

Primary outcome: Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity.

Time frame: Baseline and 4 weeks. Mean (95% Confidence Interval). Unit: Percent change post-treatment

Measure	Sham-treated; LED-treated (Split-face Study) n = 35
Sham-treated	7.34 (3.37 to 11.31)
LED-treated	20.82 (16.85 to 24.79)

Sham-treated; LED-treated (Split-face Study): Mean Difference (Final Values): 13.4, p <0.0001, ANCOVA

Population analysed: Per Protocol

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham-treated; LED-treated (Split-face Study)	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19587693Barolet 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.

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Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruiting
Integrated Actionable Aging Assessment for Cancer Patients Pilot
Breast Cancer, Hodgkin Lymphoma
Not yet recruitingObservational study
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing LumiPhase-R™, OPUSMED Inc. Montreal, Canada in people with Skin Aging and Photoaging of Skin, run by RoseLab Skin Optics Laboratory at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness). (time frame: Baseline and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00818246, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2009.