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

Primary Purpose

Acne Atrophica

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Monopolar radiofrequency
Pulsed dye laser
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Atrophica focused on measuring Acne scars, Monopolar radiofrequency, Pulsed dye laser

Eligibility Criteria

19 Years - 23 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Radwa T Elshorbagy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

monopolar radiofrequency (MRF) group

Pulsed dye laser (PDL) group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 2, 2020
Last Updated
July 7, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04461366
Brief Title
Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars
Acronym
MRFPDL
Official Title
Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Atrophica
Keywords
Acne scars, Monopolar radiofrequency, Pulsed dye laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
monopolar radiofrequency (MRF) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Pulsed dye laser (PDL) group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Monopolar radiofrequency
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Pulsed dye laser
Intervention Description
PDL was applied for the affected areas with no pre-treatment regimens or topical anaesthetics. There was no requirement for skin cooling.
Primary Outcome Measure Information:
Title
acne scars severity by investigator
Description
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.
Time Frame
after 8 weeks of intervention
Title
acne scars severity by the participant
Description
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.
Time Frame
after 8 weeks of intervention
Secondary Outcome Measure Information:
Title
emotional, social functioning and work/school effect of scars
Description
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.
Time Frame
after 8 weeks of intervention

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
adolescents
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesma M Allam, PhD
Organizational Affiliation
lecturer at faculty of physical therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radwa T Elshorbagy
City
Giza
ZIP/Postal Code
12111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
I will share data 6 months after publication
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
study protocol

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Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars

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