Ignite Creation Date:
2025-12-25 @ 1:00 AM
Ignite Modification Date:
2026-01-03 @ 6:06 PM
Study NCT ID:
NCT06411093
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Kinesiology Tape Wrapping for Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010304', 'term': 'Paronychia'}], 'ancestors': [{'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2024-05-08', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the severity of pain by Numerical Rating Scale', 'timeFrame': 'Evaluated at week 1, 2, 4, 6, 8 and 12 after the initiation of intervention', 'description': 'Patients rate the severity of pain over the tender point of the affected big toe on a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable.'}, {'measure': 'Change in the severity of paronychia by the scoring system for paronychia related to oncologic treatments (SPOT)', 'timeFrame': 'Evaluated at week 2, 4, 6, 8 and 12 after the initiation of intervention', 'description': 'The SPOT evaluates the severity of the affected big toe based on four parameters, including redness, edema, discharge and granulation tissue, each measured on a 4-point scale from 0 to 3 with 0 for no presence of signs and 3 for most severe of lesions. The total score ranges from 0 to 12.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paronychia', 'Epidermal Growth Factor Receptor Inhibitor']}, 'referencesModule': {'references': [{'pmid': '35307912', 'type': 'BACKGROUND', 'citation': 'Hsu TJ, Yeh HH, Liu KL. Kinesiology tapes wrapping for paronychia induced by epidermal growth factor receptor inhibitors: A pilot study. Dermatol Ther. 2022 Jun;35(6):e15463. doi: 10.1111/dth.15463. Epub 2022 Mar 29. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Epidermal growth factor receptor inhibitors(EGFRIs) have been applied in several common malignancies including advanced non-small cell lung cancer. Paronychia is one of the most common cutaneous side effects, characterized by inflamed granulation tissue around the nails leading to pain and reduced quality of life. Despite available conventional therapies such as topical beta-blockers or chemical cauterization, some patients still do not respond well. Our previous pilot study suggested that adding Kinesiology tape wrapping to the conventional treatment may effectively improve pain and granulomas in patients with treatment-resistant EGFRI-related paronychia, with good safety. This study aims to evaluate the clinical efficacy and safety of using Kinesiology tape wrapping as an adjunct to conventional therapy for patients with EGFRI-related paronychia.', 'detailedDescription': 'In this study, eligible patients with paronychia affecting their big toes will be included and randomized to receive a combination of Kinesiology tape wrapping and conventional treatment, or conventional treatment alone for 3 months. Patients are evaluated at baseline, at 1, 2, 4, 8, and 12 weeks after the initiation of the treatment. These evaluations will occur at the outpatient department or through phone contact and photos taken by patients if they cannot visit in person. Efficacy endpoints include pain numerical rating scale (NRS) and scoring system for paronychia related to oncologic treatments (SPOT). Besides, any side effects will be recorded at each visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EGFR inhibitors-induced paronychia\n* Having at least one big toe involved with CTCAE(Common Terminology Criteria for Adverse Events) grade 2-3 paronychia\n\nExclusion Criteria:\n\n* Younger than 20 years\n* severe ingrown nails\n* concomitant cutaneous infection\n* severe nail destruction\n* chronic paronychia with severe periungual fibrosis'}, 'identificationModule': {'nctId': 'NCT06411093', 'briefTitle': 'Efficacy and Safety of Kinesiology Tape Wrapping for Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'A Single-center, Randomized, Open-labelled Trial to Evaluate the Efficacy and Safety of the Kinesiology Tape for the Treatment of Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors in Cancer Patients', 'orgStudyIdInfo': {'id': '202001747A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A combination of Kinesiology tape wrapping and conventional treatment', 'description': 'Patients in the intervention arm will receive Kinesiology tape wrapping to separate the nail plate from the inflamed periungual tissue in addition to conventional treatment. This intervention will be applied at outpatient visits or during hospitalization. If the Kinesiology tape falls off, patients can either replace it themselves or leave it off until the next outpatient visit or unexpected hospitalization.', 'interventionNames': ['Combination Product: Kinesiology tape wrapping', 'Drug: Conventional treatment including silver nitrate cauterization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional treatment', 'description': 'Patients in this arm will receive management according to routine clinical practice, including chemical cauterization with silver nitrate, with or without topical antiseptics, topical steroids, topical beta-blockers, systemic steroids, and systemic antibiotics. The above treatment will be applied at outpatient visits or during hospitalization.', 'interventionNames': ['Drug: Conventional treatment including silver nitrate cauterization']}], 'interventions': [{'name': 'Kinesiology tape wrapping', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['"NITTO"Medical Adhesive Tape (Non-Sterile)'], 'description': 'Place Kinesiology tape between the nail plate and the inflamed periungual granulation tissue in addition to conventional treatment for 3 months', 'armGroupLabels': ['A combination of Kinesiology tape wrapping and conventional treatment']}, {'name': 'Conventional treatment including silver nitrate cauterization', 'type': 'DRUG', 'description': 'Conventional treatment including silver nitrate cauterization, with or without topical antiseptics, topical steroids, topical beta-blockers, short-term systemic antibiotics, systemic steroids for 3 months', 'armGroupLabels': ['A combination of Kinesiology tape wrapping and conventional treatment', 'Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83301', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Ting-Jung Hsu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}