Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
Study NCT ID:
NCT04461366
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2020-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054025', 'term': 'Lasers, Dye'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acne scars severity by investigator', 'timeFrame': 'after 8 weeks of intervention', '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.'}, {'measure': 'acne scars severity by the participant', 'timeFrame': 'after 8 weeks of intervention', '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.'}], 'secondaryOutcomes': [{'measure': 'emotional, social functioning and work/school effect of scars', 'timeFrame': 'after 8 weeks of intervention', '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acne scars', 'Monopolar radiofrequency', 'Pulsed dye laser'], 'conditions': ['Acne Atrophica']}, 'descriptionModule': {'briefSummary': '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.\n\nPurpose: 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '23 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'adolescents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with mild to severe acne scar\n* Patients with acne scar in the face\n\nExclusion Criteria:\n\n* Smokers and alcohol drinker\n* Patients who had a history of diabetes, circulatory or sensory disorders\n* Patients who had a history of frequent sunburns\n* Patients with nodulocystic acne'}, 'identificationModule': {'nctId': 'NCT04461366', 'acronym': 'MRFPDL', 'briefTitle': 'Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'P.T.REC/012/002410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'monopolar radiofrequency (MRF) group', '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.', 'interventionNames': ['Device: Monopolar radiofrequency']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pulsed dye laser (PDL) group', '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).', 'interventionNames': ['Device: Pulsed dye laser']}], 'interventions': [{'name': 'Monopolar radiofrequency', 'type': 'DEVICE', '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.', 'armGroupLabels': ['monopolar radiofrequency (MRF) group']}, {'name': 'Pulsed dye laser', 'type': 'DEVICE', 'description': 'PDL was applied for the affected areas with no pre-treatment regimens or topical anaesthetics. There was no requirement for skin cooling.', 'armGroupLabels': ['Pulsed dye laser (PDL) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12111', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Radwa T Elshorbagy', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Nesma M Allam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'lecturer at faculty of physical therapy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'I will share data 6 months after publication', 'accessCriteria': 'study protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Nesma Morgan Allam', 'investigatorAffiliation': 'Cairo University'}}}}