Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT04955951
Status:
TERMINATED
Last Update Posted:
2023-08-23
First Post:
2021-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasonographic Response to Polarized Light Therapy in the Treatment of Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008859', 'term': 'Microscopy, Polarization'}], 'ancestors': [{'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'forgotten', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-20', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasonography', 'timeFrame': '1-2 months', 'description': 'Ultrasound imaging system used to measure the thickness of the skin at the site of scale for both groups'}], 'secondaryOutcomes': [{'measure': 'SCORAD Score', 'timeFrame': '1-2 months', 'description': "The SCORAD (Index) is the best validated scoring system in atopic dermatitis, To measure the extent of AD, the rule of nines is applied on a front/back drawing of the patient's inflammatory lesions. The extent can be graded from 0 to 100. The intensity part of the SCORAD consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness. Each item can be graded on a scale from 0 to 3. The subjective items include daily pruritus and sleeplessness. The SCORAD Index formula is: A/5 + 7B/2 + C. In this formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The maximal score of the SCORAD Index is 103. The objective SCORAD consist of the extent and the intensity items; the formula is A/5 + 7B/2. The maximal objective SCORAD score is 83 (with 10 additional points for severe disfiguring eczema of the face and hands)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Non-atopic dermatitis (NAD) or eczema is a common inflammatory condition; potentially debilitating that can compromise quality of life. It is usually seen in childhood, but can onset within or persist into adulthood.', 'detailedDescription': 'Polarized ultraviolet-free polychromatic light is used as therapeutic option for the treatment of wound healing and dermatological conditions.\n\n40 male patients who had atopic dermatitis in the chronic stage, they were complaining from itching, inflammation and skin thickness in the arm, wrist, hand and leg will participate in this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The Patient will be referred to physical therapy outpatient clinic, faculty of physical therapy, Ahram Canadian University from dermatology out-clinics in Sheikh Zayed Hospital.', 'genderDescription': '20-30', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patients' ages will ranged from 20 to 30 years.\n* The subjects will be males.\n* The duration of disease less than 1 year.\n\nExclusion Criteria:\n\n* patients who had skin malignancy in the area to be treated.\n* The patients who had history of diabetes, circulatory or sensory disorders.\n* Patients with acute infection in the area treated."}, 'identificationModule': {'nctId': 'NCT04955951', 'briefTitle': 'Ultrasonographic Response to Polarized Light Therapy in the Treatment of Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': 'Ultrasonographic Response to Polarized Light Therapy in the Treatment of Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'AhramCUE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'polarized light group', 'description': 'group A (20 patients) will receive Polarized light therapy', 'interventionNames': ['Device: polarized light']}, {'label': 'topical corticosteroid group', 'description': 'group B (20 patients) will receive topical corticosteroid therapy', 'interventionNames': ['Drug: Topical corticosteroid ointment']}], 'interventions': [{'name': 'polarized light', 'type': 'DEVICE', 'description': 'A Bioptron light therapy phototherapeutic device (Bioptron AG, Wollerau, Switzerland) with 5 cm treatment diameter (BIOPTRON MedAll®, 480-3400 nm, polarization level of 95%, power density 40 mW/cm2, energy density 2,4 J/cm2 per minute', 'armGroupLabels': ['polarized light group']}, {'name': 'Topical corticosteroid ointment', 'type': 'DRUG', 'description': 'corticosteroid 1 %.', 'armGroupLabels': ['topical corticosteroid group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Ahram Canadian University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'ultrasonographic skin thickness results will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahram Canadian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'LECTURER', 'investigatorFullName': 'Mahmoud H Mohamed, PhD', 'investigatorAffiliation': 'Ahram Canadian University'}}}}