Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars

NCT ID: NCT04461366

Last Updated: 2020-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-07-01

Brief Summary

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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

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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.

Conditions

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Acne Atrophica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Monopolar radiofrequency

Intervention Type DEVICE

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.

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).

Group Type ACTIVE_COMPARATOR

Pulsed dye laser

Intervention Type DEVICE

PDL was applied for the affected areas with no pre-treatment regimens or topical anaesthetics. There was no requirement for skin cooling.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nesma Morgan Allam

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nesma M Allam, PhD

Role: PRINCIPAL_INVESTIGATOR

lecturer at faculty of physical therapy

Locations

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Radwa T Elshorbagy

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T.REC/012/002410

Identifier Type: -

Identifier Source: org_study_id

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