Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT06980493
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-20
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Topical Amphotericin B Solution in Treatment of Resistant Tinea Capitis in Children 16 Years Old or Less we Follow up Cases Weekly up to 8 Weeks and Notice Improvement of Itching ,Scaling, and Hair Regrowth Then Fungal Culture Done to See if the Solution Working
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014006', 'term': 'Tinea Capitis'}], 'ancestors': [{'id': 'D014005', 'term': 'Tinea'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012536', 'term': 'Scalp Dermatoses'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008081', 'term': 'Liposomes'}, {'id': 'C068538', 'term': 'liposomal amphotericin B'}], 'ancestors': [{'id': 'D008567', 'term': 'Membranes, Artificial'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D004337', 'term': 'Drug Carriers'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D040761', 'term': 'Biomimetic Materials'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-11', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-05-11', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'monitoring for reduction in size of scaling weekly for 8 weeks', 'timeFrame': '4 months', 'description': '• children 16 years old or less will be evaluated to detect an effect size of 0.3 in the rate of the disease improvement (reduction in scaling) on repeated measurements (follow up weekly for 8 weeks)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['topical amphotericin b solution in tinea capitis'], 'conditions': ['Tinea Capitis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if topical amphotericin b solution works to treat resistant cases of tinea capitis in children. It will also learn about the safety of drug. The main questions it aims to answer are:\n\nDoes amphotericin b solution effective in cases not cured by systemic antifungal tab?\n\nParticipants will:\n\nuse topical amphotericin b solution every day for8 weeks Visit the clinic once every 1 week for follow up then follow up after 1 month and fungal culture will be done to test if the treatment working', 'detailedDescription': 'The aim of the study will be to evaluate the efficacy and safety of topical amphotericin B solution in treatment of non-inflammatory type of tinea capitis after resistant response to oral systemic treatment .\n\nPatient and method After approval of the study by Research and Ethical committee at Sohag faculty of medicine, this study will include group of patients attending the outpatient clinic of Dermatology, venereology and andrology department in Sohag university hospital.\n\nAn informed written consent will be obtained from parents of all participants after full explanation of the procedure.\n\nInclusion criteria:\n\nChildren aged \\< 16 years affected by tinea capitis non inflammatory type who are clinically and dermoscopically confirmed after resistant response to oral systemic treatment for 8 weeks.\n\nStudy design : prospective clinical study. Sample Size : 30 participants.\n\nExclusion criteria:\n\nPatients with inflammatory tinea capitis, kerion or favus. Patients with known hypersensitivity to amphotericin B, other systemic conditions or ongoing use of conflicting medications.\n\nmethod All recruited children will be submitted to clinical assessment as follows\n\n* Personal history: name, age, sex, residence.\n* Family history of similar condition.\n* Medical history: received systemic antifungal treatment type, dose and for how long.\n* Laporatory investigation :CBC and liver function test.\n* Complete general examination. To exclude any systemic diseases.\n* Dermatological examination:\n\nClinical examination:\n\nDescription of the lesion (site, size, shape, presence of scales, loss of hair or Lymphadenopathy).\n\nDermoscopic examination:\n\nDermoscopic features of tinea capitis non inflammatory type includes\n\n* Comma hairs (short hairs that bend and grow back toward the scalp,resembling a comma)\n* Corkscrew hairs (short hairs that are coiled up like a corkscrew)\n* Zigzag hairs (short hairs with several bends in them like a zigzag pattern)\n* Morse code-like .\n* Bent hairs.\n* Scales, follicular keratosis, and crusts -Erythema -Broken hairs -Black dots.\n\nProcedure:\n\nPreparation Prepare a 2.5% amphotericin B solution by reconstitute liposomal amphotericin B 50 mg vial in 20 ml distilled water result in a final concentration of 2.5 mg/ml. The resulting solution will be stored in bottles with a dropper and protected from light with aluminum foil.\n\nApplication Patients apply the solution to each affected area and briefly let the solution evaporate.\n\nFrequency: Apply once daily. Duration: Continue treatment for 8 weeks or until clinical resolution with dermoscopic confirmation.\n\nTreatment Protocol Baseline assessment. Perform a thorough clinical assessment. Instruct patients/guardians on proper application techniques. Schedule weekly follow-ups for 8 weeks. Monitoring\n\n* Monitor for clinical signs of improvement: reduction in itching, scaling and hair regrowth Weekly for 8 weeks then follow up after 1 month with dermoscopic photographing .\n* A fungal culture test will be done in follow up visit after 1 month to test if the treatment is working.\n* follow up monitor for side effects: local irritation, redness or systemic reactions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '0 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged \\< 16 years affected by tinea capitis non inflammatory type who are clinically and dermoscopically confirmed after resistant response to oral systemic treatment for 8 weeks.\n\nExclusion Criteria:\n\n* Patients with inflammatory tinea capitis, kerion or favus. Patients with known hypersensitivity to amphotericin B, other systemic conditions or ongoing use of conflicting medications.'}, 'identificationModule': {'nctId': 'NCT06980493', 'acronym': 'prospective', 'briefTitle': 'Efficacy and Safety of Topical Amphotericin B Solution in Treatment of Resistant Tinea Capitis in Children 16 Years Old or Less we Follow up Cases Weekly up to 8 Weeks and Notice Improvement of Itching ,Scaling, and Hair Regrowth Then Fungal Culture Done to See if the Solution Working', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Efficacy and Safety of Topical Amphotericin B Solution in Treatment of Resistant Tinea Capitis', 'orgStudyIdInfo': {'id': 'Soh-Med-25-1-04MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'amphotericin b topical solution', 'description': 'evaluate the efficacy and safety of topical amphotericin B solution in treatment of non-inflammatory type of tinea capitis after resistant response to oral systemic treatment .', 'interventionNames': ['Drug: Amphotericine in liposome (Ambisome®)']}], 'interventions': [{'name': 'Amphotericine in liposome (Ambisome®)', 'type': 'DRUG', 'description': 'The aim of the study will be to evaluate the efficacy and safety of topical amphotericin B solution in treatment of non-inflammatory type of tinea capitis after resistant response to oral systemic treatment', 'armGroupLabels': ['amphotericin b topical solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'result of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zainab Alkassem Nour', 'investigatorAffiliation': 'Sohag University'}}}}