WrinklesNCT02091089

Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles

A study testing 755nm Alexandrite laser in people with Wrinkles, run by Cynosure, Inc. at 1 site in United States.

Completed

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

Trial summary

The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using the picosecond 755nm Alexandrite laser. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Wrinkles
What is being tested?: 755nm Alexandrite laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Nov 2014
Phase: Interventional
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is a healthy non-smoking (must have quit 1 year prior) male or female between 18 and 65 years old.
Is willing to consent to participate in the study.
Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.

Who cannot join

The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
The subject is hypersensitive to light exposure OR takes photo sensitized medication.
The subject has active or localized systemic infections.
The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.

Show all 14Show fewer

The subject has used Accutane within 6 months prior to enrollment.
The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
The subject has a history of keloids.
The subject has evidence of compromised wound healing.
The subject has a history of squamous cell carcinoma or melanoma.
The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
The subject has an allergy to lidocaine and epinephrine.

Trial locations and contacts

1 site in 1 country.

United States1 site

Maryland Laser, Skin and Vein Institute
Hunt Valley, Maryland, 21030

Other trials in United States

About this study

The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using the picosecond 755nm Alexandrite laser.

Conditions: Wrinkles
Being tested: 755nm Alexandrite laser

What participants receive

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

755nm Alexandrite laserDevice
755nm Alexandrite laser for the treatment of wrinkles

Study groups in NCT02091089
Study group	Role	What they receive
755nm Alexandrite laser	Experimental	755nm Alexandrite laser for the treatment of wrinkles Receives: Device: 755nm Alexandrite laser

What is being measured

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

Photographic Evaluation of Wrinkle Severity at Baseline
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Measured: Baseline
Photographic Evaluation of Wrinkle Severity at 1 Month Follow Up
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Measured: 1 Month Follow Up Post Last Treatment
Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Measured: 3 Month Follow Up Post Last Treatment
Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Measured: 4 months post last treatment
Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Measured: 6 months post last treatment

Timeline

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

Aug 2013Nov 2014

First posted19 Mar 2014 (estimated)
Study startAug 2013
Primary completionNov 2014
Study completionNov 2014

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.
Other trials for WrinklesStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02091089
Sponsor's protocol ID: CYN13-PICO-LENS-RW
Status last verified: Nov 2020
First submitted: 14 Mar 2014
Last updated: 27 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Wrinkles trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
ClinicalTrials.gov ID: NCT02091089
Acronym / sponsor ID: CYN13-PICO-LENS-RW
Conditions: Wrinkles
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Cynosure, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 19 Mar 2014 (estimated)
Results: Posted 27 Nov 2020

Clinical summary

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

The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using the picosecond 755nm Alexandrite laser.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
755nm Alexandrite laser	Experimental	Device: 755nm Alexandrite laser755nm Alexandrite laser for the treatment of wrinkles

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Is a healthy non-smoking (must have quit 1 year prior) male or female between 18 and 65 years old.
Is willing to consent to participate in the study.
Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.

Key exclusion criteria (14 listed)

The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
The subject is hypersensitive to light exposure OR takes photo sensitized medication.
The subject has active or localized systemic infections.
The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.

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
755nm Alexandrite laser755nm Alexandrite laser for the treatment of wrinkles	Device	755nm Alexandrite laser

Primary outcome

Photographic Evaluation of Wrinkle Severity at Baseline
Time frame: Baseline
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Photographic Evaluation of Wrinkle Severity at 1 Month Follow Up
Time frame: 1 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up
Time frame: 3 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up
Time frame: 4 months post last treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up
Time frame: 6 months post last treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

Results and safety

Results posted to the registry on 27 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
755nm Alexandrite Laser	20	18

Primary outcome: Photographic Evaluation of Wrinkle Severity at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	755nm Alexandrite Laser n = 20
Value	5.7 (0.80)

Primary outcome: Photographic Evaluation of Wrinkle Severity at 1 Month Follow Up

Time frame: 1 Month Follow Up Post Last Treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	755nm Alexandrite Laser n = 19
Value	3 (1.25)

Population analysed: One subject did not show up to their follow up appointment.

Primary outcome: Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up

Time frame: 3 Month Follow Up Post Last Treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	755nm Alexandrite Laser n = 20
Value	3 (1.28)

Primary outcome: Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up

Time frame: 4 months post last treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	755nm Alexandrite Laser n = 18
Value	3 (1.11)

Population analysed: 2 subjects did not show up for their follow ups.

Adverse events

Time frame: Adverse event data were collected from study start until 6 month post last treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
755nm Alexandrite Laser	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Wrinkles

Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
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Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
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A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies

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 study testing 755nm Alexandrite laser in people with Wrinkles, run by Cynosure, Inc. at 1 site in United States.

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 3 inclusion and 14 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 27 Nov 2020. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2020). 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?

Photographic Evaluation of Wrinkle Severity at Baseline (time frame: Baseline). The study lists 5 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 NCT02091089.

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 27 Nov 2020.