ScarNCT02032641

Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars

A study testing Laser treatment in people with Scar, run by University of Miami at 2 sites 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 determine the efficacy of the 1064nm Neodymium yttrium aluminum garnet (Nd:YAG) laser (Laser Genesis, Cutera TM) in the treatment of surgical scar after direct brow lift. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Scar
What is being tested?: Laser treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 2 sitesUnited States
Study dates: Jun 2013to May 2015
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Undergoing or have undergone direct brow lift

Who cannot join

under 18 years old
history of photodermatoses
receiving systemic isotretinoin within the preceding 6 months
undergoing other scar treatment in the brow area
pregnant patients
history of adverse outcomes related to non-ablative laser

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Bascom Palmer Eye Institute
Miami, Florida, 33136
Bascom Palmer Eye Institute
Plantation, Florida, 33324

Other trials in United States

About this study

Read the detailed description

Patients who undergo a direct brow lift may participate in this study. Participants will receive laser treatment on one of the two surgical wounds (side of treatment will be chosen randomly by an independent source). Treatment parameters will be 500 spots and 10-14 megajoules (mJ) depending on skin type. The opposite side brow scar will not be treated until 1 month after the study is completed (if the patient elects to treat the contralateral brow after study completion this will be done at no charge to the patient). This treatment will be given at 2-4 week intervals for 6 treatments. Photographs will be taken at each visit, and they will be assessed based on different parameters by an examiner, as well as judged by the patient based on overall appearance.

Conditions: Scar
Being tested: Laser treatment
Keywords: Non-ablative laser, Scar revision, direct brow lift
Medical subject headings: Cicatrix

What participants receive

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

Laser treatmentDevice
Also called Laser Genesis, Cutera, 1064 microsecond-pulsed Nd:YAG laser
Non-ablative, non-fractional, microsecond-pulsed Nd:YAG laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size

Study groups in NCT02032641
Study group	Role	What they receive
Laser Treatment Side	Experimental	Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was "too hot" as an additional safeguard against epidermal damage. Receives: Device: Laser treatment
Control side	No intervention	Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.

What is being measured

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

Relative Improvement
Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs
Measured: 1 month after final treatment

Secondary outcomes (2)

Overall Appearance
Subjects were asked to rate overall cosmesis of both the treated and control scars on a 1-10 scale, with 1 being extremely poor and 10 being extremely excellent, as rated by participant
Measured: 10 minutes before first treatment and at the final visit
Hair Loss
After each laser session, subjects were asked to rate perceived amount of hair loss from both the treated and control scars on a 1-10 scale, with 1 being none at all and 10 being extremely significant
Measured: within 1 hour after final treatment

Timeline

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

Jun 2013May 2015

First posted10 Jan 2014 (estimated)
Study startJun 2013
Primary completionMay 2015
Study completionMay 2015

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 ScarStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02032641
Sponsor's protocol ID: 20120936
Status last verified: Jan 2017
First submitted: 24 Jun 2013
Last updated: 27 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Submitted for publication but no individual participant data released

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 Scar trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars
ClinicalTrials.gov ID: NCT02032641
Acronym / sponsor ID: 20120936
Conditions: Scar
Keywords: Non-ablative laser, Scar revision, direct brow lift
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: Jun 2013
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 10 Jan 2014 (estimated)
Results: Posted 27 Jan 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Laser Treatment Side	Experimental	Device: Laser treatmentEach patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was "too hot" as an additional safeguard against epidermal damage.
Control side	No intervention	–Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Undergoing or have undergone direct brow lift

Key exclusion criteria (6 listed)

under 18 years old
history of photodermatoses
receiving systemic isotretinoin within the preceding 6 months
undergoing other scar treatment in the brow area
pregnant patients

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
Laser treatmentAlso: Laser Genesis, Cutera, 1064 microsecond-pulsed Nd:YAG laserNon-ablative, non-fractional, microsecond-pulsed Nd:YAG laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size	Device	Laser Treatment Side

Primary outcome

Relative Improvement
Time frame: 1 month after final treatment
Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs

2 secondary outcomes

Overall Appearance
Time frame: 10 minutes before first treatment and at the final visit
Hair Loss
Time frame: within 1 hour after final treatment

Results and safety

Results posted to the registry on 27 Jan 2017, 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 and Control Group	9	8

Primary outcome: Relative Improvement

Time frame: 1 month after final treatment. Mean (Standard Deviation). Unit: percentage of times treated scar chosen

Measure	Laser Treatment Side n = 8	Control Scar n = 8
Value	50.0 (12.5)	50.0 (12.5)

Population analysed: 3 graders masked to treatments were asked to judge side-by-side photographs of first and final visits for which scar improved more. Each pair of before-and-after photos was graded twice by each examiner. Results are percentage of times treated scar was chosen by examiners as most improved (an analysis of 6 results per pair of photos).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years, 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Laser Right, Non-laser Left	0 of 5 (0%)	0 of 5 (0%)	Not reported
Laser Left, Non-laser RIght	0 of 4 (0%)	0 of 4 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Submitted for publication but no individual participant data released

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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.

Sara Wester, MD principal investigator

University of Miami

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

Questions about this trial

What is this clinical trial studying?

A study testing Laser treatment in people with Scar, run by University of Miami at 2 sites 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 1 inclusion and 6 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 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Jan 2017). 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?

Relative Improvement (time frame: 1 month after final treatment). 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 NCT02032641.

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 Jan 2017.