Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars

Not Applicable

Completed

• Conditions: Acne Atrophica
• Interventions: Device: Pulsed dye laser; Device: Monopolar radiofrequency

• Registration Number: NCT04461366
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2019-01-15
• Primary Completion: 2019-12-30
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-02
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed dye laser (PDL) group	Pulsed dye laser	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).
monopolar radiofrequency (MRF) group	Monopolar radiofrequency	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.

Primary Outcome Measures

Name	Time	Method
acne scars severity by investigator	after 8 weeks of intervention	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	after 8 weeks of intervention	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

Name	Time	Method
emotional, social functioning and work/school effect of scars	after 8 weeks of intervention	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.

Trial Locations

Locations (1)

Radwa T Elshorbagy; 🇪🇬 Giza, Egypt