Fractional CO2 Laser for Burn Scars
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Must not be taking: Steroids, Antihistamines, Opioids, others
Disqualifiers: Epilepsy, Seizure disorder, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Hypertrophic Burn Scars (HTBS) are often treated with Fractional CO2 laser therapy to improve cosmetic appearance. It has been noted that this leads to a reduction in the pain and itch associated with this type of scars. While this phenomenon is commonly described in the literature, the mechanism of pain and itch reduction in unclear. The investigators aim to better understand this process by histological evaluation of HTBS at different stages of laser treatment.
Do I need to stop my current medications for the trial?
Yes, you will need to stop taking certain medications, especially those that interfere with wound healing, itch, or pain, such as steroids, antihistamines, opioids, and some others.
What data supports the effectiveness of the treatment Luminis Ultrapulse Fractional Ablative Carbon Dioxide Laser for burn scars?
Research shows that fractional carbon dioxide laser treatment significantly improves the appearance and texture of mature burn scars, with patients reporting a 44.44% improvement in their overall assessment of their scars. The treatment also enhances the arrangement and amount of collagen and elastic fibers in the skin, contributing to better scar relief and pliability.
12345Is the Fractional CO2 Laser generally safe for humans?
The Fractional CO2 Laser is generally considered safe for treating scars and other skin conditions, but some side effects have been reported, such as skin discoloration and prolonged healing time. It's important to discuss potential risks with your doctor, especially if you have had previous treatments like silver-impregnated dressings.
12367How is the Luminis Ultrapulse Fractional CO2 Laser treatment different from other treatments for burn scars?
The Luminis Ultrapulse Fractional CO2 Laser is unique because it uses a specialized laser that can target scars with precision, offering both non-sequential and sequential scanning options to improve scar appearance. This method is different from traditional treatments like dermabrasion, as it allows for more controlled and effective resurfacing of the skin.
12689Eligibility Criteria
This trial is for individuals with hypertrophic burn scars that are painful, itchy, or hypersensitive. Participants must have had the burn within the last two years and be planning to undergo laser treatment. They should agree to biopsies and a year of follow-up. Pregnant individuals or those on certain medications like steroids, antihistamines, pain relief drugs, or those affecting wound healing cannot join.Inclusion Criteria
I am planning to have laser treatment for my burn scar.
Patient must be willing and able to participate in the study with a year of follow-up
Not be pregnant or planning to become pregnant during the treatment phase of the study
+4 more
Exclusion Criteria
Current treatment with other procedures or drugs (experimental or other) in area of interest
I do not have any health issues that prevent me from getting laser treatment.
My study scar is not near areas needing surgery.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo standard treatment with fractional CO2 laser and additional skin biopsies, along with completing Patient Reported Outcome Measure questionnaires
7 months
Multiple visits for laser treatment and assessments
Follow-up
Participants are monitored for histological changes and symptomatic improvement after treatment
4 weeks
Participant Groups
The study tests how effective Fractional CO2 laser therapy (Luminis ultrapulse) is in reducing pain and itchiness in hypertrophic burn scars. It involves histological evaluations over different stages of treatment to understand the underlying mechanisms behind symptom improvement.
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz
Luminis Ultrapulse Fractional Ablative Carbon Dioxide Laser is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Fractional CO2 Laser for:
- Hypertrophic Burn Scars
- Scar Reconstruction
- Burn Scar Management
🇪🇺 Approved in European Union as Fractional CO2 Laser for:
- Burn Scar Treatment
- Scar Resurfacing
- Hypertrophic Scar Management
🇨🇦 Approved in Canada as Lumenis UltraPulse for:
- Burn Scar Reconstruction
- Scar Treatment
- Hypertrophic Burn Scar Management
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
References
Dystrophic calcification and accentuated localized Argyria after fractionated carbon dioxide laser therapy of hypertrophic scars. [2016]Fractionated, ultrapulsed carbon dioxide (CO2) laser therapy is a powerful tool for the treatment of scars. Common adverse effects of this therapeutic modality have been previously documented. We describe 2 unreported adverse effects of ultrapulsed CO2 laser treatment of mature scars in a patient previously treated with silver-impregnated dressings.
Ultrapulsed fractional CO2 laser for the treatment of post-traumatic and pathological scars. [2012]Scar management is a long-term process. A variety of modalities have been employed and, depending on scar type, treatment may be invasive and/or conservative. The purpose of this study was to evaluate a new CO2 laser resurfacing for post-traumatic and pathological scars and to compare this device with classic dermabrasion. The new fractionated ultrapulsed CO2 laser (Ultrapulse Encore, Lumenis Ltd., Santa Clara, CA) is equipped with two types of scanners: the first, ActiveFX, is non-sequential while the second, DeepFX, is sequential and produces microspot.
[Clinical effects of different modes of ultra pulse carbon dioxide fractional laser used in combination on the treatment of hypertrophic scar on face and neck]. [2018]To explore the clinical effects of ultra pulse mode of ultra pulse carbon dioxide fractional laser combined with Deep FX mode or Scaar FX mode on the treatment of patients with hypertrophic scars on face and neck.
Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Mature Burn Scars: A Clinical, Histopathological, and Histochemical Study. [2020]OBJECTIVE: The purpose of this study was to evaluate the efficacy of fractional carbon dioxide laser use in the treatment of mature burn scars. DESIGN: This was an uncontrolled, open-label clinical trial. SETTING: The setting for this study was Dermatology Department at Cairo University in Cairo, Egypt. PARTICIPANTS: Twenty patients with mature burn scars were included in the study. MEASUREMENTS: Three fractional carbon dioxide laser sessions were given, 4 to 8 weeks apart. Primary outcome was measured using two scar scales, the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale. Secondary outcomes included evaluation of collagen and elastic fibers using routine hematoxylin and eosin, Masson's trichrome, and orcein stains. Outcomes were measured two months after the last laser session. RESULTS: Both Vancouver Scar Scale and Patient and Observer Scar Assessment Scale showed significant reduction following treatment (p<0.001). Scar relief and pliability improved most followed by vascularity. Pigmentation improved the least. Percent improvement in Patient and Observer Scar Assessment Scale patients' overall assessment was 44.44 percent. The pattern and arrangement of collagen and elastic fibers showed significant improvement (p<0.001, p=0.001, respectively), together with significant improvement in their amounts (p=0.020, p<0.001, respectively). No significant correlation existed between clinical and histopathological/histochemical scores. Side effects and complications were mild and tolerable. CONCLUSION: Fractional carbon dioxide laser use is an effective and safe method for treating burn scars with a significant change in the opinion of the patients about their scar appearance.
Fractional CO2 laser to improve noticeable scars after skin cancer surgery: An appraisal by the patients, laypersons, and experts. [2022]Ablative fractionated carbon dioxide (fCO2 ) laser may be a useful tool to improve noticeable scars after skin cancer surgery. Therefore we evaluated 40 patients who have been treated with fCO2 laser for facial scars after skin cancer surgery. This retrospective study is based on blinded evaluation of pre- and postoperative photographs. Patients (n = 40), laypersons (n = 5) and experts (n = 5) evaluated the esthetics and the Vancouver scar scale as primary endpoints. Secondary endpoints included patient satisfaction and treatment safety. Patients, laypersons and experts consistently assessed a significant improvement of scar quality and appearance after fCO2 laser treatment, which was paralleled by high patient satisfaction. In conclusion, ablative fCO2 laser is effective in improving noticeable postsurgical scars. Patients are highly satisfied with post-laser results.
Ultrapulse-mode versus superpulse-mode fractional carbon dioxide laser on normal back skin. [2016]Ultrapulse-mode (UPCO2) and superpulse-mode (SPCO2) fractional carbon dioxide lasers have been widely used to treat photo-aged skin, acne scars, and other skin conditions. This study was designed to compare the efficacy of new SPCO2 and UPCO2 lasers.
A randomized guinea pig study on external cell growth factors after fractional ultrapulsed CO(2) laser therapy. [2013]The Fractional Ultrapulsed CO2 laser has been successfully used in treating fine wrinkles, acne scars, and photoaged skin. However, the downtime typically lasts a week or more. The purpose of this study was to observe the efficacy of external cell growth factors after Fractional Ultrapulsed CO2 laser therapy.
Early postoperative treatment of thyroidectomy scars using a fractional carbon dioxide laser. [2022]Ablative carbon dioxide fractional laser systems (CO(2) FS) have been effectively used to improve the appearance of scarring after surgical procedures, but an optimal treatment time has not been established.
Lower-fluence, higher-density versus higher-fluence, lower-density treatment with a 10,600-nm carbon dioxide fractional laser system: a split-face, evaluator-blinded study. [2015]Adequate laser settings in the treatment of scars using a carbon dioxide fractional laser system (CO(2) FS) have not been established.