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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861248
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date  ICMJE August 2, 2016
First Posted Date  ICMJE August 10, 2016
Last Update Posted Date August 10, 2016
Study Start Date  ICMJE March 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cicatrix
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2016)
95
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02861248
Other Study ID Numbers  ICMJE Plasma-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP