Benign Pigmented and Vascular Lesions and ScarsNCT01745627

755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars

A study testing 755nm Alex laser in people with Benign Pigmented and Vascular Lesions and Scars, 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.

Official record

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Trial summary

Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Benign Pigmented and Vascular Lesions and Scars
What is being tested?: 755nm Alex laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Dec 2013
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 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male or female subjects between 18 and 85 years of age.
Subjects with Fitzpatrick skin types I to VI.
Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars
Subject who are willing to consent to participate in the study.
4.2 Exclusion Criteria
Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule

Show all 18Show fewer

Hypersensitive to light exposure.
Active localized or systemic infections.
Taking medication for which sunlight is a contraindication.
History of squamous cell carcinoma or melanoma.
History of keloid scarring.
Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
Prior treatment with laser or other devices in treatment area within 3 months
History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period.
Subjects that the physician determines ineligible based on standard of care treatment.
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-

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Laser & Skin Surgery Center of New York
New York, New York, 10016

Other trials in United States

About this study

Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars

Conditions: Benign Pigmented and Vascular Lesions and Scars
Being tested: 755nm Alex laser
Medical subject headings: Cicatrix

What participants receive

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

755nm Alex laserDevice

Study groups in NCT01745627
Study group	Role	What they receive
Laser Treatment	Experimental	Not described Receives: Device: 755nm Alex laser

What is being measured

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

Clearance Based on Photographic Scale
This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.
Measured: 1 months post last treatment
Clearance Based on Photographic Scale
This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.
Measured: 3 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.

Oct 2011Dec 2013

First posted10 Dec 2012 (estimated)
Study startOct 2011
Primary completionDec 2013
Study completionDec 2013

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 Benign Pigmented and Vascular Lesions and ScarsStudies 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: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01745627
Sponsor's protocol ID: CYN11-PICO_RG2_PL
Status last verified: Dec 2020
First submitted: 6 Dec 2012
Last updated: 23 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars
ClinicalTrials.gov ID: NCT01745627
Acronym / sponsor ID: CYN11-PICO_RG2_PL
Conditions: Benign Pigmented and Vascular Lesions and Scars
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Cynosure, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 10 Dec 2012 (estimated)
Results: Posted 23 Dec 2020

Clinical summary

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

Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars

Study design

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

Arm	Type	Receives
Laser Treatment	Experimental	Device: 755nm Alex laser

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Healthy male or female subjects between 18 and 85 years of age.
Subjects with Fitzpatrick skin types I to VI.
Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars
Subject who are willing to consent to participate in the study.
4.2 Exclusion Criteria

Key exclusion criteria (0 listed)

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 Alex laser	Device	Laser Treatment

Primary outcome

Clearance Based on Photographic Scale
Time frame: 1 months post last treatment
This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.
Clearance Based on Photographic Scale
Time frame: 3 months post last treatment
This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.

Results and safety

Results posted to the registry on 23 Dec 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
Laser Treatment	42	20

Primary outcome: Clearance Based on Photographic Scale

Time frame: 1 months post last treatment. Count of participants. Unit: Participants

Measure	Laser Treatment n = 15
>75%	2
51-74%	2
26-50%	4
0-25%	7

Population analysed: 19 subjects were lost to follow up after their treatment. 2 subjects did not have clearance data but had photographs for each of the follow up visits. 4 subjects did not attend the 1 month follow up, but attended a 3 month follow up, so their data was included. 2 subjects were not included in the trial.

Primary outcome: Clearance Based on Photographic Scale

Time frame: 3 months post last treatment. Count of participants. Unit: Participants

Measure	Laser Treatment n = 13
>75%	2
51-74%	2
26-50%	4
0-25%	5

Population analysed: 19 subjects were lost to follow up, 2 subjects did not have clearance data but had photographs for each of the follow up visits. 6 subjects did not have data for this follow up visit but had data for the 1 month follow up visit, so their data were included. 2 subjects were not included in the trial.

Adverse events

Time frame: Adverse Events occurring were captured and followed for each patient's participation in the study, approximately 26 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Laser Treatment	0 of 42 (0%)	17 of 42 (40.5%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Patricia Krantz study director

Cynosure, Inc.

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 Alex laser in people with Benign Pigmented and Vascular Lesions and Scars, 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 18 inclusion and 0 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 23 Dec 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 23 Dec 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?

Clearance Based on Photographic Scale (time frame: 1 months post last treatment). 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 NCT01745627.

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 23 Dec 2020.