ScarNCT02988622

Comparison of Lasers in the Treatment of Scars

A study testing Fraxel Laser and CO2 Laser in people with Scar, run by Marta Hemmingson-Van Beek 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

The purpose of this study is to compare the 1550-nm non-ablative Fraxel laser (referred to as Fraxel Laser in this application) to the ablative 10,600-nm carbon dioxide fractional laser (referred to as CO2 Laser in this application) to determine if one is superior to the other in improving the appearance of scars over… Read more about this study

Who is it for?: Ages 18 to 120 yearsHealthy volunteers can take part
Conditions the study is for: Scar
What is being tested?: Fraxel Laser and CO2 Laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Jan 2016to 15 Jan 2018
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 120 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 18 or older.
Fitzpatrick skin type I-IV.
Scars secondary to surgery or trauma.
Scar length minimum 4 cm in length.

Who cannot join

Scars less than 6 weeks old.
History of keloid scarring.
Use of isotretinoin currently or within 3 months of enrollment
Use of photosensitive medication currently or within 3 months of enrollment.
Pregnancy -

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa Health Care, Department of Dermatology
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: 1550-nm Non Ablative Laser (Fraxel) Versus Ablative 10,600-nm Carbon Dioxide (CO2) Fractional Laser in the Treatment of Surgical and Traumatic Scars: A Comparison Study on Efficacy, Treatment Regimen, and Cost.

Read the detailed description

This study will be accomplished through a controlled split-scar study design whereby half of the scar will be treated with the Fraxel Laser and the other half of the scar will be treated with the CO2 Laser. This study is a blinded, prospective comparative, split-scar study whereby 100 participants will be recruited, enrolled and followed for a period of 9 months. The study population will include male and female participants, age 18 and over with scars secondary to surgery or trauma on any part of the body. The study will recruit participants with light colored skin, Fitzpatrick Type I-IV, because colored skin has a significantly higher risk of keloid scarring. The scar must measure a minimum of 4 cm in length to accommodate for the split-scar treatment. The participants will undergo laser treatments on Visit 1, Visit 2 and Visit 3 and each visit will be 4 weeks apart. The participants will return for evaluation and follow-up 3 months and 6 months following the last laser treatment. At each visit, photographs will be taken using identical camera settings, lighting and participant positioning. Evaluation of the scars will be completed by the participants and by blinded dermatology physicians. Participants will use a complete visual analogue scale at each visit, the Patient and Observer Scar Assessment Scale (POSAS) and a satisfaction score.

Conditions: Scar
Being tested: Fraxel Laser, CO2 Laser
Medical subject headings: Cicatrix

What participants receive

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

Fraxel LaserDevice
One half of the scar is treated with Fraxel Laser
CO2 LaserDevice
One half of the scar is treated with CO2 Laser.

Study groups in NCT02988622
Study group	Role	What they receive
Scar treated with Fraxel and CO2 laser	Other	One half of scar is treated with Fraxel laser and the other half of scar is treated with CO2 laser. Receives: Device: Fraxel Laser; Device: CO2 Laser

What is being measured

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

Scar Pain
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Measured: Baseline and 6 months
Scar Itching
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Measured: Baseline and 6 months
Scar Color
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Measured: Baseline and 6 months
Scar Stiffness
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Measured: Baseline and 6 months
Scar Thickness
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Measured: Baseline and 6 months
Scar Irregularity
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Measured: Baseline and 6 months
Overall Opinion
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Measured: Baseline and 6 months
Patient Satisfaction
Patients rated how satisfied they were with the appearance of each half of the treated scar.
Measured: 6 months
Observer Total Score
Change in total observer score made up of components rating the scar appearance based on photos at baseline and photos at 6 months. Scale includes the following components: Visual analog scale from 0 to 10 (with 0 being excellent appearance and 10 being worst appearance), scar color, contour and distortion (these 3 measures were graded from 1 to 4 with 1 equating to perfect and 4 equating to worst appearance), scar finish (matte scar was given a score of 1 and shiny scar was given a score of 2). The total score of the above components provided an overall observer score, with 4 being the best score possible (equating to best appearing scar) and 24 being the worst score possible (equating to worst appearing scar).
Measured: Baseline and 6 months.

Timeline

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

Jan 201615 Jan 2018

First posted9 Dec 2016 (estimated)
Study startJan 2016
Primary completion15 Jan 2018
Study completion15 Jan 2018

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.
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: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02988622
Sponsor's protocol ID: 201509722
Status last verified: Mar 2018
First submitted: 28 Nov 2016
Last updated: 18 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: Yes
Individual data sharing: 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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Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 1550-nm Non Ablative Laser (Fraxel) Versus Ablative 10,600-nm Carbon Dioxide (CO2) Fractional Laser in the Treatment of Surgical and Traumatic Scars: A Comparison Study on Efficacy, Treatment Regimen, and Cost.
ClinicalTrials.gov ID: NCT02988622
Acronym / sponsor ID: 201509722
Conditions: Scar
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Marta Hemmingson-Van BeekUniversity, hospital or other
Study start: Jan 2016 (actual)
Primary completion: 15 Jan 2018 (actual)
Study completion: 15 Jan 2018 (actual)
First posted: 9 Dec 2016 (estimated)
Results: Posted 8 Dec 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Scar treated with Fraxel and CO2 laser	Other	Device: Fraxel Laser, Device: CO2 LaserOne half of scar is treated with Fraxel laser and the other half of scar is treated with CO2 laser.

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18 or older.
Fitzpatrick skin type I-IV.
Scars secondary to surgery or trauma.
Scar length minimum 4 cm in length.

Key exclusion criteria (5 listed)

Scars less than 6 weeks old.
History of keloid scarring.
Use of isotretinoin currently or within 3 months of enrollment
Use of photosensitive medication currently or within 3 months of enrollment.
Pregnancy -

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
Fraxel LaserOne half of the scar is treated with Fraxel Laser	Device	Scar treated with Fraxel and CO2 laser
CO2 LaserOne half of the scar is treated with CO2 Laser.	Device	Scar treated with Fraxel and CO2 laser

Primary outcome

Scar Pain
Time frame: Baseline and 6 months
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Scar Itching
Time frame: Baseline and 6 months
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Scar Color
Time frame: Baseline and 6 months
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Scar Stiffness
Time frame: Baseline and 6 months
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Scar Thickness
Time frame: Baseline and 6 months
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Scar Irregularity
Time frame: Baseline and 6 months
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Overall Opinion
Time frame: Baseline and 6 months
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Patient Satisfaction
Time frame: 6 months
Patients rated how satisfied they were with the appearance of each half of the treated scar.
Observer Total Score
Time frame: Baseline and 6 months.
Change in total observer score made up of components rating the scar appearance based on photos at baseline and photos at 6 months. Scale includes the following components: Visual analog scale from 0 to 10 (with 0 being excellent appearance and 10 being worst appearance), scar color, contour and distortion (these 3 measures were graded from 1 to 4 with 1 equating to perfect and 4 equating to worst appearance), scar finish (matte scar was given a score of 1 and shiny scar was given a score of 2). The total score of the above components provided an overall observer score, with 4 being the best score possible (equating to best appearing scar) and 24 being the worst score possible (equating to worst appearing scar).

Results and safety

Results posted to the registry on 8 Dec 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
Scar is Treated With Fraxel Laser and CO2 Laser	100	83

Primary outcome: Scar Pain

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Scar is Treated With Fraxel Laser n = 100	Scar Treated With CO2 Laser n = 100
Baseline	1.265 (0.938)	1.181 (0.608)
6 months	1.048 (0.215)	1.084 (0.474)

Scar is Treated With Fraxel Laser vs Scar Treated With CO2 Laser: Mean Difference (Net): 0.1205, p = 0.0492, t-test, 2 sided

Population analysed: Patients with available data at the 6-month time point.

Primary outcome: Scar Itching

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Scar is Treated With Fraxel Laser n = 100	Scar Treated With CO2 Laser n = 100
Baseline	1.386 (0.853)	1.337 (0.873)
6 months	1.084 (0.568)	1.277 (1.140)

Scar is Treated With Fraxel Laser vs Scar Treated With CO2 Laser: Mean Difference (Net): 0.2410, p = 0.0817, t-test, 2 sided

Population analysed: Patients with available data at the 6-month time point.

Primary outcome: Scar Color

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Scar is Treated With Fraxel Laser n = 100	Scar Treated With CO2 Laser n = 100
Baseline	5.622 (2.623)	5.518 (2.661)
6 months	4.108 (2.078)	4.313 (2.112)

Scar is Treated With Fraxel Laser vs Scar Treated With CO2 Laser: Mean Difference (Net): 0.3659, p = 0.0686, t-test, 2 sided

Population analysed: Patients with available data at the 6-month time point.

Primary outcome: Scar Stiffness

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Scar is Treated With Fraxel Laser n = 100	Scar Treated With CO2 Laser n = 100
Baseline	4.361 (2.770)	4.518 (2.856)
6 months	3.313 (2.112)	3.386 (2.094)

Scar is Treated With Fraxel Laser vs Scar Treated With CO2 Laser: Mean Difference (Net): -0.0843, p = 0.6278, t-test, 2 sided

Population analysed: Patients with available data at the 6-month time point.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Scar is Treated With Fraxel Laser	0 of 100 (0%)	3 of 100 (3%)	0 of 100
Scar Treated With CO2 Laser	0 of 100 (0%)	3 of 100 (3%)	0 of 100

Limitations and caveats (from the sponsor): This is the largest split scar study comparing the C02 laser and Fraxel laser, however despite this the numbers are still relatively small overall. 100 patients were enrolled in teh study but only 83 completed the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Pooja Chitogopeker, MD principal investigator

University of Iowa

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

Questions about this trial

What is this clinical trial studying?

A study testing Fraxel Laser and CO2 Laser in people with Scar, run by Marta Hemmingson-Van Beek 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 4 inclusion and 5 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 18 Oct 2018. 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 8 Dec 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?

Scar Pain (time frame: Baseline and 6 months). The study lists 9 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 NCT02988622.

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 18 Oct 2018.