Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-05 @ 5:12 PM
Study NCT ID:
NCT06492356
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Tripolar Radiofrequency on Acne Scar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'single-blinded randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the change in severity of acne scars', 'timeFrame': 'at base line and following 12 weeks', 'description': 'SCARS is a 5-item instrument designed to rate the severity of acne scars in a mirror. It uses visual analog scales to differentiate between active and scars. The tool is self-completion and can be completed quickly. Patients are photographed at the beginning and after 12 treatment sessions. SCARS scores range from 0 to 4, with higher scores indicating greater severity. It captures demographic information and clinical characteristics of acne and scarring.'}], 'secondaryOutcomes': [{'measure': 'Assessing the quantitative measurement of the acne scars', 'timeFrame': 'at base line and following 12 weeks', 'description': 'Dey et al. developed an automatic approach to quantify acne scars using color images, achieving a sensitivity of 90.36 and specificity of 93.82. However, this method does not allow for volumetric assessment of the scar. Another technique, proposed by Petukhova et al., uses three-dimensional photographic images to construct a topographic map, which is then objectively calculated for each scar. This method does not assess color changes like dyspigmentation, which is essential for tracking scars over time. Further testing is needed to improve this method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Scars - Mixed Atrophic and Hypertrophic', 'Scar', 'Radiofrequency']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the therapeutic efficacy of tripolar radiofrequency on acne scar', 'detailedDescription': "Acne scarring is a very troublesome complication associated with acne and is reported in as high as 95% of the patients, sometimes even with proper and prompt treatment. The visible depressed scars have been known to have a negative impact on patient's psychological well-being and quality of life. Post acne scarring can pose as a risk factor for depression, anxiety, and even suicide (Villani, 2020).\n\nThere are a multitude of treatment options that are traditionally used for the treatment of acne scars including many ablative and non-ablative methods (Dogra, 2014).\n\nFurth more, the need of this study is developed from the lack in quantitative knowledge and information in the published studies which investigate the effect of tripollar RF This study will be designed to provide guidelines about the effect tripollar Radiofrequency on acne scars."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Forty patients having acne scar, from both genders their ages will be ranged from 20 to 40 years old\n* Both genders will participate in this study as the following distribution 17 male and 23 female.\n* They diagnosed as acne scar by their physicians and referred for physical therapy management.\n* Medically and psychologically stable patients.\n* All patients will approve and sign a consent form before starting the program which will include the purpose, natures and potential risks of the study which will be explained to all patients\n\nExclusion Criteria:\n\n* Patients who suffer from hypertrophic and/or keloidal scars and a skin condition in the area of acne scars that would interfere with study procedures (e.g., plaque psoriasis, tattoo, birthmark, facial hair).\n* Patients with medical red flags as severe psychiatric disorder or cognitive deficits.\n* Medically unstable and uncooperative patients.\n* Untreated and active/ongoing acne vulgaris.\n* Immunocompromised status.\n* History of skin cancer.\n* Recurrent herpes viral infection.\n* Pregnancy or breastfeeding status.\n* Females take contraceptive pills\n* Hormonal disturbance'}, 'identificationModule': {'nctId': 'NCT06492356', 'briefTitle': 'Impact of Tripolar Radiofrequency on Acne Scar', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Impact of Tripolar Radiofrequency on Acne Scar', 'orgStudyIdInfo': {'id': 'Alshymaa M.sc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Consists of 20 patients with acne scars and will receive medical treatment by a dermatologist and tripolar radiofrequency (RF) therapy once a week for 12 weeks, each session for 15 minutes.', 'interventionNames': ['Device: Tripolar radiofrequency therapy', 'Drug: medical treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'consists of 20 patients with acne scars and will receive medical treatment by a dermatologist', 'interventionNames': ['Drug: medical treatment']}], 'interventions': [{'name': 'Tripolar radiofrequency therapy', 'type': 'DEVICE', 'description': 'Twenty patients underwent weekly TriPollar RF treatment, using a new RF technology with three or more electrodes. Glycerin was applied to the treatment area before and after each session, with the procedure lasting 15 minutes. The technology uses a sequence of electrical modulation to prevent overheating and requires no active cooling of the electrodes or skin.', 'armGroupLabels': ['Group A']}, {'name': 'medical treatment', 'type': 'DRUG', 'description': 'Twenty patients will receive medical treatment by dermatologist.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minya', 'country': 'Egypt', 'facility': 'Malawy Specialized Hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alshymaa Ahmed Kamel Ahmed', 'investigatorAffiliation': 'Cairo University'}}}}