Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-31 @ 1:44 AM
Study NCT ID:
NCT03831269
Status:
UNKNOWN
Last Update Posted:
2019-02-05
First Post:
2019-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017514', 'term': 'Pityriasis Lichenoides'}], 'ancestors': [{'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010267', 'term': 'Parapsoriasis'}, {'id': 'D010915', 'term': 'Pityriasis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-03', 'studyFirstSubmitDate': '2019-01-25', 'studyFirstSubmitQcDate': '2019-02-03', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Azithromycin in treating pityriasis lichenoides chronica', 'timeFrame': '12 months', 'description': 'The clinical improvement of patients with PLC will be evaluated after taking 3 to 6 cycles of azithromycin and will be compared to the clinical outcome of patients that had three sessions of nbUVB for six to eight weeks. Side effects will be documented in each group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pityriasis Lichenoides']}, 'referencesModule': {'references': [{'pmid': '36129521', 'type': 'DERIVED', 'citation': 'Elbendary A, Youssef R, Abdel-Halim MRE, Abdel Halim D, El Sharkawy DA, Alfishawy M, Gad MA, Gad A, Elmasry MF. Role of streptococcal infection in the etiopathogenesis of pityriasis lichenoides chronica and the therapeutic efficacy of azithromycin: a randomized controlled trial. Arch Dermatol Res. 2023 Apr;315(3):521-530. doi: 10.1007/s00403-022-02398-0. Epub 2022 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'Primary outcome:\n\nThe primary outcome at end of study (EOS) is to compare the therapeutic efficacy of Azithromycin in the treatment of pityriasis lichenoides chronica (PLC) with that of a well-documented line of therapy namely narrow band ultra violet B (nbUVB).\n\nSecondary outcomes:\n\n1\\. To identify the possibility of streptococcal throat infection as a possible underlying etiology in PLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with classic papular eruption of PLC (scaly erythematous papules with mica-like scales) with diagnosis documented histopathologically with or without associated hypopigmented lesions\n2. Age: \\> 6 years\n3. Both sexes.\n\nExclusion Criteria:\n\n1. Patients presenting with only hypopigmented macules whom their skin biopsy revealed PLC.\n2. Patients with hypopigmented lesions that reveal mycosis fungoides pathologically.\n3. Patients with PLC associated with classic MF.\n4. Patients with known absolute contraindications to NB-UVB.\n5. Patients with impaired liver and/or kidney functions.\n6. Patients with history of any heart disease.\n7. Patients with known hypersensitivity to Azithromycin\n\n \\-'}, 'identificationModule': {'nctId': 'NCT03831269', 'briefTitle': 'Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Role of Streptococcal Infection in the Etiopathogenesis of Pityriasis Lichenoides Chronica and the Therapeutic Efficacy of Azithromycin; a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Kasr Alainy Cairo U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Azithromycin', 'description': "The dose of azithromycin will be 10mg/kg/day oral suspension for 3 consecutive days for pediatric patients (\\<12 years old) and 500mg/day in three consecutive days for adults. The cycle will be repeated every seven days (3 cycles/month) and will be repeated if required according to patient's response up to 6 cycles. Side effects of therapy will be recorded. This protocol is based on previous case reports.", 'interventionNames': ['Drug: Azithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nb UVB', 'description': "Patients recruited for nbUVB phototherapy will have an initial dose of 0.3J-0.5J according to Fitzpatrick's skin type. The dosage will be increased by 0.3J in every other treatment session. The sessions will be given 3 times weekly until improvement is noted or reaching 8 weeks at the EOS. We arrived at this initial dose based on our previous experience with Egyptian patients in Kasr Alainy phototherapy unit in Dermatology Department, Cairo University.", 'interventionNames': ['Other: nbUVB']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'description': 'Patients will be randomly distributed and start taking azithromycin according to the known dose /kg/day for repeated cycles till improvement or reaching the end of study', 'armGroupLabels': ['Azithromycin']}, {'name': 'nbUVB', 'type': 'OTHER', 'description': 'The patients will be randomly distributed to start nbUVB sessions and clinical improvement will be compared to that of Azithromycin', 'armGroupLabels': ['Nb UVB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Mona Abdel Haleim, MD', 'role': 'CONTACT', 'email': 'abdelhalimmona@gmail.com'}], 'facility': 'Kasr Alainy Faculty of Medicine Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Amira Elbendary, MBBCh, MSc', 'role': 'CONTACT', 'email': 'aelbendary@kasralainy.edu.eg', 'phone': '+201555668584'}, {'name': 'Elbendary, MBBCh, MSc', 'role': 'CONTACT', 'email': 'amira.elbendary@yahoo.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Email contact'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching assistant', 'investigatorFullName': 'Amira Elbendary', 'investigatorAffiliation': 'Cairo University'}}}}