Acne AtrophicaMRFPDLNCT04461366
Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars
A study testing Monopolar radiofrequency and Pulsed dye laser in people with Acne Atrophica, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Atrophica
- What is being tested?
- Monopolar radiofrequency and Pulsed dye laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2019to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with mild to severe acne scar
- Patients with acne scar in the face
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acne Atrophica
- Being tested
- Monopolar radiofrequency, Pulsed dye laser
- Keywords
- Acne scars, Monopolar radiofrequency, Pulsed dye laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monopolar radiofrequencyDevice
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 laserDevice
PDL was applied for the affected areas with no pre-treatment regimens or topical anaesthetics. There was no requirement for skin cooling.
| Study group | Role | What they receive |
|---|---|---|
| monopolar radiofrequency (MRF) group | Experimental | 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. Receives: Device: Monopolar radiofrequency |
| Pulsed dye laser (PDL) group | Active comparator | 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). Receives: Device: Pulsed dye laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after 8 weeks of intervention
Secondary outcomes (1)
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.
Measured: after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start15 Jan 2019
- Primary completion30 Dec 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne AtrophicaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
- Investigators
- Nesma M Allam, PhD, Principal investigator, lecturer at faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461366
- Sponsor's protocol ID
- P.T.REC/012/002410
- Acronym
- MRFPDL
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will share data 6 months after publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04461366
- Acronym / sponsor ID
- MRFPDL / P.T.REC/012/002410
- Conditions
- Acne Atrophica
- Keywords
- Acne scars, Monopolar radiofrequency, Pulsed dye laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monopolar radiofrequency (MRF) group | Experimental | Device: Monopolar radiofrequencyMonopolar 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. |
| Pulsed dye laser (PDL) group | Active comparator | Device: Pulsed dye laserFlash 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). |
Who may qualify
- Ages
- 19 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with mild to severe acne scar
- Patients with acne scar in the face
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monopolar radiofrequencyThe 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. | Device | monopolar radiofrequency (MRF) group |
| Pulsed dye laserPDL was applied for the affected areas with no pre-treatment regimens or topical anaesthetics. There was no requirement for skin cooling. | Device | Pulsed dye laser (PDL) group |
Primary outcome
acne scars severity by investigator
Time frame: 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
Time frame: 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.
1 secondary outcome
emotional, social functioning and work/school effect of scars
Time frame: after 8 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: Yes. I will share data 6 months after publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nesma M Allam, PhD principal investigator
lecturer at faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monopolar radiofrequency and Pulsed dye laser in people with Acne Atrophica, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acne scars severity by investigator (time frame: after 8 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.