Hypertrophic ScarNCT04769089

Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.

A study testing Treatment with Pulse Dye Laser, Treatment with CO2 Laser and Treatment with combination of pulse dye laser and CO2 laser. in people with Hypertrophic Scar, run by The Metis Foundation 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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hypertrophic Scar
What is being tested?: Treatment with Pulse Dye Laser, Treatment with CO2 Laser and Treatment with combination of pulse dye laser and CO2 laser.
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 19 Dec 2017to 24 Jun 2020
Phase: Interventional
Are there results?: None posted in the registry

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

Must have at least four areas of burn scar located on the trunk or extremities measuring 3cm x 3cm and not previously treated with laser.
Timing: There has been a minimum of 1 month after burn closure
The subject is at least 18 years of age and not older than 65.
Able and willing to provide verbal and written consent.

Who cannot join

Active infection in experimental area
Use of isotretinoin (Accutane) in last six months
Life or limb-threatening injury/disease
Prior history of non-compliance with medical regimes
Active drug use/abuse
Active psychiatric illness except depression (unless being treated for suicidal intentions)

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Pregnancy
Active cancer, or new diagnosis of cancer within the past 5 years, with the exception of basal cell carcinoma, melanoma and squamous cell carcinoma, as long as the subject is disease free at the time of enrollment.
Prior PDL or other laser treatment of the study area.
Patient unable to tolerate laser procedure.

Trial locations and contacts

1 site in 1 country.

United States1 site

United States Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234

Other trials in United States

About this study

A prospective, double blind, randomized controlled human clinical trial will be conducted by enrolling patients referred for laser treatment from the USAISR burn clinic. Laser candidates will be asked to participate who have an area of extremity or truncal scar measuring approximately 6cmX6cm total, in one contiguous region. The study sites, will consist of four equally sized treatment areas (3cm x 3cm), will be randomized to be treated with PDL, CO2, a combination of CO2+PDL, and an untreated control for 6 treatments. The areas will be photographed prior to each treatment and at the final visit 4-6 months after the last treatment. Color, pliability and thickness will be measured using a colorimeter, cutometer and high frequency ultrasound respectively at each appointment. Additionally, the Patient Observer Scar Assessment Scale (POSAS) will be used to score the quality of the scar, using two trained, blinded observers. The patients will also be asked on a voluntary basis for a pre-trial and post-trial 3mm punch biopsy to evaluate for the presence of histological changes.

Conditions: Hypertrophic Scar
Being tested: Treatment with Pulse Dye Laser, Treatment with CO2 Laser, Treatment with combination of pulse dye laser and CO2 laser., Control
Medical subject headings: Cicatrix, Hypertrophic

What participants receive

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

Treatment with Pulse Dye LaserProcedure or surgery
Pulse Dye laser treatment will be applied to one randomized area with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s.
Treatment with CO2 LaserProcedure or surgery
CO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density.
Treatment with combination of pulse dye laser and CO2 laser.Procedure or surgery
Pulse Dye laser and CO2 treatment will be applied to one randomized area. Pulse Dye will be applied with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s followed by the CO2 laser treatment with the deep Fx hand piece, 300Hz, 15mJ, 15% density.
ControlOther
One area will be randomized to receive no laser treatment.

Study groups in NCT04769089
Study group	Role	What they receive
Pulse Dye Laser	Experimental	Treatment with PDL alone. Receives: Procedure: Treatment with Pulse Dye Laser
CO2 Laser	Experimental	Treatment with CO2 alone. Receives: Procedure: Treatment with CO2 Laser
Combination	Experimental	Treatment with both PDL and CO2 laser. Receives: Procedure: Treatment with combination of pulse dye laser and CO2 laser.
No treatment	Active comparator	No laser treatment. Receives: Other: Control

What is being measured

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

Effectiveness of laser treatments
Using the Patient and Observer Scar Assessment Scale (POSAS), evaluate the effectiveness of Pulse Dye Laser (PDL) and Carbon Dioxide (CO2) laser treatment on symptoms related to Hypertrophic Burn Scar (HBS)
Measured: 4-6 weeks post treatment

Secondary outcomes (1)

Improvement of symptoms
To longitudinally compare the change in symptoms by treatment modality between treatment sessions by assessment with the Patient and Observer Scar Assessment Scale (POSAS) measured for each patient and two observers (to increase score reliability) at each follow-up visit.
Measured: 4-6 weeks post treatment

Timeline

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

19 Dec 201724 Jun 2020

First posted24 Feb 2021
Study start19 Dec 2017
Primary completion24 Jun 2020
Study completion24 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hypertrophic 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04769089
Sponsor's protocol ID: M-10590
Status last verified: Feb 2021
First submitted: 8 Feb 2021
Last updated: 24 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cooper LE, Nuutila K, Kemp Bohan PM, Diaz V, Batchinsky M, Carlsson AH, Cancio LC, Chan RK. Analysis of the Utility of CO2 and Pulse-Dye Lasers Together and Separately in the Treatment of Hypertrophic Burn Scars. Ann Plast Surg. 2022 Aug 1;89(2):166-172. doi: 10.1097/SAP.0000000000003240.
PubMed 35943226

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

Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruitingPhase 2
Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars
Hypertrophic Scars
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation
Recruiting
AVAVA MIRIA General Use
Acne, Acne Scars - Mixed Atrophic and Hypertrophic

All Hypertrophic Scar trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.
ClinicalTrials.gov ID: NCT04769089
Acronym / sponsor ID: M-10590
Conditions: Hypertrophic Scar
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: The Metis FoundationUniversity, hospital or other
Collaborators: United States Army Institute of Surgical Research
Study start: 19 Dec 2017 (actual)
Primary completion: 24 Jun 2020 (actual)
Study completion: 24 Jun 2020 (actual)
First posted: 24 Feb 2021 (actual)
Results: Not posted in the source record

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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Pulse Dye Laser	Experimental	Procedure: Treatment with Pulse Dye LaserTreatment with PDL alone.
CO2 Laser	Experimental	Procedure: Treatment with CO2 LaserTreatment with CO2 alone.
Combination	Experimental	Procedure: Treatment with combination of pulse dye laser and CO2 laser.Treatment with both PDL and CO2 laser.
No treatment	Active comparator	Other: ControlNo laser treatment.

Who may qualify

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

Key inclusion criteria (4 listed)

Must have at least four areas of burn scar located on the trunk or extremities measuring 3cm x 3cm and not previously treated with laser.
Timing: There has been a minimum of 1 month after burn closure
The subject is at least 18 years of age and not older than 65.
Able and willing to provide verbal and written consent.

Key exclusion criteria (10 listed)

Active infection in experimental area
Use of isotretinoin (Accutane) in last six months
Life or limb-threatening injury/disease
Prior history of non-compliance with medical regimes
Active drug use/abuse

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
Treatment with Pulse Dye LaserPulse Dye laser treatment will be applied to one randomized area with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s.	Procedure or surgery	Pulse Dye Laser
Treatment with CO2 LaserCO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density.	Procedure or surgery	CO2 Laser
Treatment with combination of pulse dye laser and CO2 laser.Pulse Dye laser and CO2 treatment will be applied to one randomized area. Pulse Dye will be applied with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s followed by the CO2 laser treatment with the deep Fx hand piece, 300Hz, 15mJ, 15% density.	Procedure or surgery	Combination
ControlOne area will be randomized to receive no laser treatment.	Other	No treatment

Primary outcome

Effectiveness of laser treatments
Time frame: 4-6 weeks post treatment
Using the Patient and Observer Scar Assessment Scale (POSAS), evaluate the effectiveness of Pulse Dye Laser (PDL) and Carbon Dioxide (CO2) laser treatment on symptoms related to Hypertrophic Burn Scar (HBS)

1 secondary outcome

Improvement of symptoms
Time frame: 4-6 weeks post treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Derived from this study: PubMed 35943226Cooper LE, Nuutila K, Kemp Bohan PM, Diaz V, Batchinsky M, Carlsson AH, Cancio LC, Chan RK. Analysis of the Utility of CO2 and Pulse-Dye Lasers Together and Separately in the Treatment of Hypertrophic Burn Scars. Ann Plast Surg. 2022 Aug 1;89(2):166-172. doi: 10.1097/SAP.0000000000003240.
Individual participant dataSharing planned: No

Related trials for Hypertrophic Scar

Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruitingPhase 2
Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars
Hypertrophic Scars
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation
Recruiting
AVAVA MIRIA General Use
Acne, Acne Scars - Mixed Atrophic and Hypertrophic

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.

Rodney Chan, MD principal investigator

Metis Foundation

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

Questions about this trial

What is this clinical trial studying?

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 10 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 24 Feb 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Effectiveness of laser treatments (time frame: 4-6 weeks post 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 NCT04769089, 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 24 Feb 2021.