Hypertrophic ScarsLIBERTINCT02655211
Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial
A study testing CO2 laser treatment and PDL laser treatment in people with Hypertrophic Scars, run by University of North Carolina, Chapel Hill.
Trial summary
This study will evaluate the efficacy of pulsed dye laser (PDL) and carbon dioxide (CO2) laser in conjunction with usual care (MED) for the treatment of hypertrophic burn scars and will determine the optimal sequence and timing of lasers and usual care. Read more about this study
- Who is it for?
- Ages 6 months to 99 years
- Conditions the study is for
- Hypertrophic Scars
- What is being tested?
- CO2 laser treatment and PDL laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2017
- 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 6 months to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- have a burn injury which will be at least 6 months old at the time of first treatment,
- have one or more symptomatic burn scars (with at least one or more symptoms such as erythema, pruritus, surface irregularity, or tightness not caused by a contracture that would be better served with surgical treatment),
- desire laser treatment,
- be at least 6 months of age at the time of treatment,
- agree to have no aesthetic treatments for their burn scars, such as peels or fillers, until they have completed the study (two-year period),
- agree to be randomized into one of the study's treatment conditions,
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- agree to return for all treatment and follow-up visits for the two-year study period,
- agree to refrain from participating in any other treatment-oriented clinical trial for the duration of this study, and
- be able and willing to follow the protocol requirements.
Who cannot join
- be women who are pregnant or planning to become pregnant during the study,
- have had any previous laser treatment of their burn scars,
- have open wounds that are not re-epithelialized in the areas of proposed study treatment,
- be taking systemic steroids or immunosuppression medication,
- have a connective tissue disorder,
- be receiving or planning to receive chemotherapy or radiation during the study,
- be medically unable to tolerate anesthesia, or
- have other conditions that in the opinion of the investigators or clinicians may affect participant safety or compromise study objectives.
About this study
Official title: Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial: The Sequential Multiple Assignment Randomized Trial (SMART) Approach to Treatment of Hypertrophic Burn Scars
This study will evaluate the efficacy of pulsed dye laser (PDL) and carbon dioxide (CO2) laser in conjunction with usual care (MED) for the treatment of hypertrophic burn scars and will determine the optimal sequence and timing of lasers and usual care.
Read the detailed description
The investigator will compare usual care (MED), which will be offered to all patients, to two types of laser treatment (PDL and CO2), which the investigators hypothesize to be beneficial. The timing and sequence of therapy will be randomized, but all patients will receive some form of laser treatment. If the investigators simply stopped at the end of Aim 1, the investigators would complete a traditional randomized control trial (RCT), with some patients potentially receiving laser treatment. However, the investigators are interested in determining whether the sequence of laser treatments is beneficial; therefore, the investigators will be employing a sequential multiple assignment randomized trial (SMART) design. Because of the nature of the study and SMART design, the investigators will offer all patients some form of laser therapy.
- Conditions
- Hypertrophic Scars
- Being tested
- CO2 laser treatment, PDL laser treatment, Usual care
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 laser treatmentProcedure or surgery
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
PDL laser treatmentProcedure or surgery
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual careOther
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
| Study group | Role | What they receive |
|---|---|---|
| CO2-CO2-Med | Active comparator | Participants will receive two blocks of CO2 laser treatment, followed by one block of usual care. Receives: Procedure: CO2 laser treatment; Other: Usual care |
| Med-CO2-CO2 | Active comparator | Participants will receive one block of usual care, followed by two blocks of CO2 laser therapy. Receives: Procedure: CO2 laser treatment; Other: Usual care |
| CO2-Med-CO2 | Active comparator | Participants will receive one block of CO2 laser therapy, one block of usual care, and finally one more block of CO2 laser therapy. Receives: Procedure: CO2 laser treatment; Other: Usual care |
| PDL-PDL-MED | Active comparator | Participants will receive two blocks of PDL laser therapy, followed by one block of usual care. Receives: Procedure: PDL laser treatment; Other: Usual care |
| Med-PDL-PDL | Active comparator | Participants will receive one block of usual care, followed by two blocks of PDL laser therapy. Receives: Procedure: PDL laser treatment; Other: Usual care |
| PDL-Med-PDL | Active comparator | Participants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy. Receives: Procedure: PDL laser treatment; Other: Usual care |
| PDL-CO2-Med | Active comparator | Participants will receive one block of PDL laser therapy, followed by one block of CO2 laser therapy, followed by one block of usual care. Receives: Procedure: CO2 laser treatment; Procedure: PDL laser treatment; Other: Usual care |
| CO2-PDL-Med | Active comparator | Participants will receive one block of CO2 laser therapy, followed by one block of PDL laser therapy, followed by one block of usual care. Receives: Procedure: CO2 laser treatment; Procedure: PDL laser treatment; Other: Usual care |
| Med-PDL-CO2 | Active comparator | Participants will receive one block of usual care, followed by one block of PDL laser therapy, followed by one block of CO2 laser therapy. Receives: Procedure: CO2 laser treatment; Procedure: PDL laser treatment; Other: Usual care |
| Med-CO2-PDL | Active comparator | Participants will receive one block of usual care, followed by one block of CO2 laser therapy, followed by one block of PDL laser therapy. Receives: Procedure: CO2 laser treatment; Procedure: PDL laser treatment; Other: Usual care |
| PDL-Med-CO2 | Active comparator | Participants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of CO2 laser therapy. Receives: Procedure: CO2 laser treatment; Procedure: PDL laser treatment; Other: Usual care |
| CO2-Med-PDL | Active comparator | Participants will receive one block of CO2 laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy. Receives: Procedure: CO2 laser treatment; Procedure: PDL laser treatment; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hypotrophic scar score on the Vancouver Scar Scale (VSS) from baseline to three month visit
Measured: Baseline and 3 months
Secondary outcomes (1)
Long-term hypotrophic scar score on VSS
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Due to staff shortages we are closing the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Hultman, MD, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655211
- Sponsor's protocol ID
- 13-0735
- Acronym
- LIBERTI
- Status last verified
- Apr 2017
- First submitted
- 12 Nov 2014
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial: The Sequential Multiple Assignment Randomized Trial (SMART) Approach to Treatment of Hypertrophic Burn Scars
- ClinicalTrials.gov ID
- NCT02655211
- Acronym / sponsor ID
- LIBERTI / 13-0735
- Conditions
- Hypertrophic Scars
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to staff shortages we are closing the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Jan 2016 (estimated)
- 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.
This study will evaluate the efficacy of pulsed dye laser (PDL) and carbon dioxide (CO2) laser in conjunction with usual care (MED) for the treatment of hypertrophic burn scars and will determine the optimal sequence and timing of lasers and usual care.
Detailed description
The investigator will compare usual care (MED), which will be offered to all patients, to two types of laser treatment (PDL and CO2), which the investigators hypothesize to be beneficial. The timing and sequence of therapy will be randomized, but all patients will receive some form of laser treatment. If the investigators simply stopped at the end of Aim 1, the investigators would complete a traditional randomized control trial (RCT), with some patients potentially receiving laser treatment. However, the investigators are interested in determining whether the sequence of laser treatments is beneficial; therefore, the investigators will be employing a sequential multiple assignment randomized trial (SMART) design. Because of the nature of the study and SMART design, the investigators will offer all patients some form of laser therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| CO2-CO2-Med | Active comparator | Procedure: CO2 laser treatment, Other: Usual careParticipants will receive two blocks of CO2 laser treatment, followed by one block of usual care. |
| Med-CO2-CO2 | Active comparator | Procedure: CO2 laser treatment, Other: Usual careParticipants will receive one block of usual care, followed by two blocks of CO2 laser therapy. |
| CO2-Med-CO2 | Active comparator | Procedure: CO2 laser treatment, Other: Usual careParticipants will receive one block of CO2 laser therapy, one block of usual care, and finally one more block of CO2 laser therapy. |
| PDL-PDL-MED | Active comparator | Procedure: PDL laser treatment, Other: Usual careParticipants will receive two blocks of PDL laser therapy, followed by one block of usual care. |
| Med-PDL-PDL | Active comparator | Procedure: PDL laser treatment, Other: Usual careParticipants will receive one block of usual care, followed by two blocks of PDL laser therapy. |
| PDL-Med-PDL | Active comparator | Procedure: PDL laser treatment, Other: Usual careParticipants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy. |
| PDL-CO2-Med | Active comparator | Procedure: CO2 laser treatment, Procedure: PDL laser treatment, Other: Usual careParticipants will receive one block of PDL laser therapy, followed by one block of CO2 laser therapy, followed by one block of usual care. |
| CO2-PDL-Med | Active comparator | Procedure: CO2 laser treatment, Procedure: PDL laser treatment, Other: Usual careParticipants will receive one block of CO2 laser therapy, followed by one block of PDL laser therapy, followed by one block of usual care. |
| Med-PDL-CO2 | Active comparator | Procedure: CO2 laser treatment, Procedure: PDL laser treatment, Other: Usual careParticipants will receive one block of usual care, followed by one block of PDL laser therapy, followed by one block of CO2 laser therapy. |
| Med-CO2-PDL | Active comparator | Procedure: CO2 laser treatment, Procedure: PDL laser treatment, Other: Usual careParticipants will receive one block of usual care, followed by one block of CO2 laser therapy, followed by one block of PDL laser therapy. |
| PDL-Med-CO2 | Active comparator | Procedure: CO2 laser treatment, Procedure: PDL laser treatment, Other: Usual careParticipants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of CO2 laser therapy. |
| CO2-Med-PDL | Active comparator | Procedure: CO2 laser treatment, Procedure: PDL laser treatment, Other: Usual careParticipants will receive one block of CO2 laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy. |
Who may qualify
- Ages
- 6 months to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- have a burn injury which will be at least 6 months old at the time of first treatment,
- have one or more symptomatic burn scars (with at least one or more symptoms such as erythema, pruritus, surface irregularity, or tightness not caused by a contracture that would be better served with surgical treatment),
- desire laser treatment,
- be at least 6 months of age at the time of treatment,
- agree to have no aesthetic treatments for their burn scars, such as peels or fillers, until they have completed the study (two-year period),
Key exclusion criteria (8 listed)
- be women who are pregnant or planning to become pregnant during the study,
- have had any previous laser treatment of their burn scars,
- have open wounds that are not re-epithelialized in the areas of proposed study treatment,
- be taking systemic steroids or immunosuppression medication,
- have a connective tissue disorder,
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 |
|---|---|---|
| CO2 laser treatmentSurgical treatment using fractionated ablative carbon dioxide laser (CO2) | Procedure or surgery | CO2-CO2-Med, CO2-Med-CO2, CO2-Med-PDL, CO2-PDL-Med, Med-CO2-CO2, Med-CO2-PDL, Med-PDL-CO2, PDL-CO2-Med, PDL-Med-CO2 |
| PDL laser treatmentSurgical treatment using flashlamp-excited pulsed dye laser (PDL) | Procedure or surgery | CO2-Med-PDL, CO2-PDL-Med, Med-CO2-PDL, Med-PDL-CO2, Med-PDL-PDL, PDL-CO2-Med, PDL-Med-CO2, PDL-Med-PDL, PDL-PDL-MED |
| Usual careUsual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting) | Other | CO2-CO2-Med, CO2-Med-CO2, CO2-Med-PDL, CO2-PDL-Med, Med-CO2-CO2, Med-CO2-PDL, Med-PDL-CO2, Med-PDL-PDL, PDL-CO2-Med, PDL-Med-CO2, PDL-Med-PDL, PDL-PDL-MED |
Primary outcome
Change in Hypotrophic scar score on the Vancouver Scar Scale (VSS) from baseline to three month visit
Time frame: Baseline and 3 months
1 secondary outcome
Long-term hypotrophic scar score on VSS
Time frame: Two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
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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.
Scott Hultman, MD principal investigator
UNC-Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing CO2 laser treatment and PDL laser treatment in people with Hypertrophic Scars, run by University of North Carolina, Chapel Hill.
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 9 inclusion and 8 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: withdrawn, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Hypotrophic scar score on the Vancouver Scar Scale (VSS) from baseline to three month visit (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2017.