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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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 Summary:

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.


Sponsor: Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: 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: Same as current

Current Secondary Outcome: 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: Same as current

Information By: Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: August 2, 2016
Date Started: March 2012
Date Completion:
Last Updated: August 5, 2016
Last Verified: August 2016