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

Cicatrix Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861248
• Other study ID #: Plasma-1
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 5, 2016
• Start date: March 2012
• Est. completion date: October 2014

Study information

• Verified date: August 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial Summary

A prospective study to evaluate the efficacy and safety of FMRT for treating non-hypertrophic post-burn scars in an Asian population.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
China	Laser division of Plastic Surgery Department, Shanghai 9th people's hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POSAS score	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.	From baseline to 6 months after final treatment	No
Secondary	Complications	Complication including edema, erythema, infection, dyschromia, hypertrophic scar formation or any other complications reported	From baseline to 6 months after final treatment	No