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

S

Shanghai Jiao Tong University School of Medicine

Status

Completed

Conditions

Cicatrix

Treatments

Procedure: Fractional micro-plasma radiofrequency treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02861248
Plasma-1

Details and patient eligibility

About

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

Full 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.

Enrollment

95 patients

Sex

All

Ages

10 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

95 participants in 1 patient group

Laser treatment
Experimental group
Description:
Fractional micro-plasma radiofrequency treatment given to 95 patients with non-hypertrophic burn scar.
Treatment:
Procedure: Fractional micro-plasma radiofrequency treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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