WithdrawnNot Applicable

Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial

Stopped: Due to staff shortages we are closing the study.

0Started 2016-12

Plain-language 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.

Who can participate

Age range

6 Months – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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, * 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. Exclusion Criteria: * 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 compromi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Hypotrophic scar score on the Vancouver Scar Scale (VSS) from baseline to three month visit

Timeframe: Baseline and 3 months

Trial details

NCT IDNCT02655211

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

View on ClinicalTrials.gov More Hypertrophic Scars trials

Who can participate

Age range

6 Months – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.