Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars (MRFPDL)

Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars: A Randomized Clinical Trial

Background: The acne scar is a common disorder characterized by skin eruption or abnormalities on face, chest, and/or back in the adolescence which affect the cosmetic appearance.

Purpose: The main aim of this study was to investigate whether monopolar radiofrequency (MRF) or pulsed dye laser (PDL) is more effective in the cases suffering from acne scars in the form of reducing acne scars and improving the cosmetic appearance.

Study Overview

• Status: Completed
• Conditions: Acne Atrophica
• Intervention / Treatment: Device: Monopolar radiofrequency; Device: Pulsed dye laser

Detailed Description

Thirty patients suffering from moderate or severe acne scars were randomly assigned into two equal groups. Group A (MRF group): received 2 sessions per week with MRF for 8 weeks. Group B (PDL group): received 1 session per week with PDL for 8 weeks. The severity of acne scars was assessed before and after treatment by using the clinical evaluation scale for acne scarring (ECCA) scale and the self-assessment of clinical acne-related scars (SCARS) scale. Quality of life and the emotional impact of acne scars were evaluated by the facial acne scar quality of life (FASQoL) scale.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12111
    • Radwa T Elshorbagy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 23 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with mild to severe acne scar
• Patients with acne scar in the face

Exclusion Criteria:

• Smokers and alcohol drinker
• Patients who had a history of diabetes, circulatory or sensory disorders
• Patients who had a history of frequent sunburns
• Patients with nodulocystic acne

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: monopolar radiofrequency (MRF) group; Monopolar Radiofrequency Diathermy (LVT-250, Korea) was used at average energy160-180 W, main power 50/60 Hz, 40˚C ~ 45˚C Temperature, RF output 470 kHz, 20 mm electrode size.	Device: Monopolar radiofrequency; The RF electrode was moved randomly for 30 seconds over each scar. The total duration of the treatment session is only 5 minutes for each cheek. It takes 15 minutes if the forehead and 2 cheeks are affected.
Active Comparator: Pulsed dye laser (PDL) group; Flash lamp pulsed dye laser; Candela SPTL-1 (Candela Corp., Wayland, Mass.) with the following parameters: (585nm wavelength, 450 msec pulse duration, 6.5 to 7.5 J/cm² energy density and 5or 7mm spot size).	Device: Pulsed dye laser; PDL was applied for the affected areas with no pre-treatment regimens or topical anaesthetics. There was no requirement for skin cooling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acne scars severity by investigator	Clinical evaluation scale for acne scarring. Using this scale, the type of scar was defined by the qualitative descriptions of scars, which is then accompanied by a numerical score (0-4) and then multiplied by (15-50) which is a weighting factor of clinical severity, the total possible score is from 0 to 540. Higher score means worse outcome while lower score means better out come.	after 8 weeks of intervention
acne scars severity by the participant	Self-assessment of clinical acne-related scars questionnaire. It consists of 5-items with 1 hypothesized domain which asks patients to assess acne scars severity as seen in the mirror. The total possible score is from 0- 20. Higher score means worse outcome while lower score means better out come.	after 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
emotional, social functioning and work/school effect of scars	Facial acne scar quality of life scale. It is a tool formed of 10-items with 3 domains to assess the emotional, social functioning and work/school effect of scars on a 5-point rating scale The total possible score is from 0- 40. Higher score means worse outcome while lower score means better out come.	after 8 weeks of intervention

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Nesma M Allam, PhD, lecturer at faculty of physical therapy

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pulsed dye laser; Acne scars; Monopolar radiofrequency
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: P.T.REC/012/002410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: I will share data 6 months after publication
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: study protocol
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No