Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients

• ClinicalTrials.gov Identifier: NCT02861248
• Recruitment Status: Completed
• First Posted: August 10, 2016
• Last Update Posted: August 10, 2016
• Sponsor: Shanghai Jiao Tong University School of Medicine
• Information provided by (Responsible Party): Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine

Tracking Information

• First Submitted Date: August 2, 2016
• First Posted Date: August 10, 2016
• Last Update Posted Date: August 10, 2016
• Study Start Date: March 2012
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 5, 2016)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 5, 2016)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients
• Official Title: Not Provided
• Brief Summary: A prospective study to evaluate the efficacy and safety of FMRT for treating non-hypertrophic post-burn scars in an Asian population.

Detailed Description

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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cicatrix

Intervention

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.

Study Arms

Experimental: Laser treatment

Fractional micro-plasma radiofrequency treatment given to 95 patients with non-hypertrophic burn scar.

Intervention: Procedure: Fractional micro-plasma radiofrequency treatment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 5, 2016): 95
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• patients with ≥1-year-old non-hypertrophic burn scars

Exclusion Criteria:

• pregnancy or breastfeeding
• history of hypertrophic scars or keloids
• abnormal medical examination including routine blood count, liver and kidney functions and immune function
• history of treatment including surgery, dermabrasion, laser treatment within the past 6 months
• the presence of a cardiac pacemaker or other metallic implant near the treatment site.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02861248
• Other Study ID Numbers: Plasma-1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine
• Study Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shanghai Jiao Tong University School of Medicine
• Verification Date: August 2016