Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients
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|ClinicalTrials.gov Identifier: NCT02861248|
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cicatrix||Procedure: Fractional micro-plasma radiofrequency treatment||Not Applicable|
Background: Laser therapy is an emerging, minimally invasive treatment for scars. Among the various techniques, fractional microplasma radiofrequency technology (FMRT) has proved to be effective for various types of scars and skin conditions such as rhytids, striae distensae, and hyperpigmentation.
Method: A prospective clinical trial was conducted to evaluate the efficacy and safety of FMRT for treating non-hypertrophic post-burn scars in an Asian population. All patients underwent three to five treatment sessions at intervals of 8-16 weeks. The patient and observer scar assessment scales (POSAS) were use to evaluate changes in the burn scars before and after treatment. Intermediate and long-term adverse events were recorded for outcome analysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Laser treatment
Fractional micro-plasma radiofrequency treatment given to 95 patients with non-hypertrophic burn scar.
Procedure: Fractional micro-plasma radiofrequency treatment
After the patient's scars were subjected to a mild cleanser and 70% alcohol, a topical cream of 5% lidocaine hydrochloric acid (Beijing Ziguang Medication Manufacture Corporation Ltd, Beijing, China) was applied to the entire scar surface under occlusion for 60-90 min before treatment to achieve local anesthesia. Fractional micro-plasma radiofrequency treatment (Pixel RF, Accent XL; Alma Lasers, Caesarea, Israel) was applied using a roller tip at 50-80 watts. Three or four passes were made in different directions over each affected area. A high rolling speed of roughly 5 cm/s was manually controlled. This treatment was accompanied by an air cooler (Cryo 5; Zimmer, Warsaw, IN, USA) for pain control. All patients attended three to five treatment sessions at intervals of 8-16 weeks.
- POSAS score [ Time Frame: From baseline to 6 months after final treatment ]The patient component of the POSAS contains six parameters that the patient scores: pain, itching, color, stiffness, thickness, relief. The physician (observer) component contains five parameters: vascularization, pigmentation, pliability, thickness, relief. Each parameter is scored from 1 to 10, with 1 indicating that the scar similar to normal skin and 10 indicating the worst situation imaginable.
- Complications [ Time Frame: From baseline to 6 months after final treatment ]Complication including edema, erythema, infection, dyschromia, hypertrophic scar formation or any other complications reported
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861248
|Laser division of Plastic Surgery Department, Shanghai 9th people's hospital|
|Shanghai, China, 200011|