Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:10 AM
Study NCT ID:
NCT07311759
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-31
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Intralesional 0.5% Triamcinolone Acetonide in 0.2% Fluconazole Solution vs 0.1% Topical Mometasone Furoate With 2% Miconazole Nitrate Cream in the Treatment of Chronic Paronychia: An Intraindividual Randomized Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}, {'id': 'D000068656', 'term': 'Mometasone Furoate'}, {'id': 'D008825', 'term': 'Miconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-17', 'size': 473639, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-11T17:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The affected fingernails in each patient are randomized, by simple randomization technique, to either receive intralesional or topical treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between the chronic paronychia severity index scale before and after treatment in each group', 'timeFrame': '4 months', 'description': 'Evaluation of proximal and lateral nail fold involvement, edema, erythema, nail plate changes and cuticle involvement for each affected nail before and after treatment using the chronic paronychia severity index score according to Atis et al, 2018 to measure the efficacy of each group on its own'}, {'measure': 'Comparison of the change in chronic paronychia severity index scale between both groups', 'timeFrame': '4 months', 'description': 'According also to Atis et al, 2018. We will grade the affected nails using the chronic paronychia severity index scale and measure the difference between before and after treatment between both groups, where pre-treatment evaluation to check for any bias and post-treatment to check which intervention was more superior.'}, {'measure': 'Comparison of percentage of patients who achieved complete response (chronic paronychia severity index scale =0) between both groups.', 'timeFrame': '4 months', 'description': 'We will assess whether the patient had a complete response or not according to the chronic paronychia severity index scale equals to zero'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intralesional triamcinolone', 'Chronic paronychia', 'Intralesional fluconazole'], 'conditions': ['Chronic Paronychia']}, 'descriptionModule': {'briefSummary': 'Our objective is to compare the efficacy and safety of intralesional corticosteroids + fluconazole solution to corticosteroid with an antifungal topical preparation, in the management of chronic paronychia.', 'detailedDescription': "Chronic paronychia (CP) is defined as inflammation of the nail fold(s) of more than 6 weeks duration (Shafritz and Coppage, 2014). It is now considered as a form of hand eczema, caused primarily by irritation of the nail folds by environmental allergens. This leads to recurrent inflammation of nail folds, followed by fibrosis and inability to generate the cuticle, ending in loss of the waterproof seal, moisture retention, and compromise of blood supply due to fibrosis. These can explain why CP is commonly resistant to topical and even systemic treatments. Candida infection is thought to be a secondary event in a subset of cases (Relhan and Bansal, 2022), with positive fungal culture in about 56.1% of cases (Bahunuthula et al., 2015) Important risk factors for the development of CP include occupations with excessive exposure to moisture and irritants (e.g. housewives, cooks, and health care providers), immunosuppression (e.g. diabetes mellitus and HIV); due to increased risk of secondary colonization, and some medications (e.g. retinoids) (Relhan and Bansal, 2022). A higher incidence of contact sensitization and Candida hypersensitivity in these patients has been reported, (Bahunuthula et al., 2015) thus candidal control may be of help to ameliorate the disease.\n\nClinically, CP presents with erythema, pain and swelling of one or more of the nail folds for \\>6 weeks. It generally affects multiple fingernails, more commonly, of the dominant hand. Nail matrix may be secondarily affected leading to transverse ridging, discoloration, Beau's lines, or onychomadesis (Shafritz and Coppage, 2014, Atiş et al.,2018). The last updated severity scale for CP has been proposed in 2018, taking into account the number of affected nail folds, erythema, edema, nail plate and cuticle changes (Atiş et al.,2018).\n\nManagement of CP relies mainly on avoidance of the irritants and topical corticosteroids which are now considered the mainstay of treatment (Shafritz and Coppage, 2014). Systemic antifungals are used in cases with associated candida infection (Tosti et al., 2002).\n\nIntralesional steroid injection, in the form of monthly injections of triamcinolone acetonide (2.5- 10 mg/mL), is used for the treatment of nail psoriasis, nail lichen planus and twenty-nail dystrophy. It is, however, scarcely mentioned in literature in the management of CP (Baran, 2001). In addition, the optimal treatment regimen and injection technique have not yet been established, and no recent relevant studies exist.\n\nSurgical treatment is reserved for cases of CP of more than 6-month duration, that has been resistant to medical treatment (Relhan et al., 2014)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with chronic paronychia affecting ≥ 2 fingernails in the dominant hand.\n2. Patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study\n3. Patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study\n\nExclusion Criteria:\n\n1. Patient with peripheral vascular disease or Raynaud's phenomenon\n2. Pregnant and lactating females\n3. Patients with autoimmune diseases e.g., connective tissue diseases, psoriasis, reactive arthritis, and pemphigus.\n4. Patients with solid or hematological malignancies.\n5. Patients on systemic drugs that are known to cause chronic paronychia e.g. retinoids.\n6. Patients with any visible focus of infection at the injection site or in the vicinity, including patients with superimposed attack of acute paronychia.\n7. Onychomycosis or any associated nail disease"}, 'identificationModule': {'nctId': 'NCT07311759', 'briefTitle': 'Safety and Efficacy of Intralesional 0.5% Triamcinolone Acetonide in 0.2% Fluconazole Solution vs 0.1% Topical Mometasone Furoate With 2% Miconazole Nitrate Cream in the Treatment of Chronic Paronychia: An Intraindividual Randomized Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Safety and Efficacy of Intralesional 0.5% Triamcinolone Acetonide in 0.2% Fluconazole Solution vs 0.1% Topical Mometasone Furoate With 2% Miconazole Nitrate Cream in the Treatment of Chronic Paronychia: An Intraindividual Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'N-255-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intralesional Triamcinolone acetonide and fluconazole', 'description': 'The proximal nail fold is cleansed with alcohol. Triamcinolone acetonide and fluconazole in the ratio of 1:7, yielding a triamcinolone acetonide concentration of 5mg/ml, is injected through the affected nail fold with a 30-gauge, 1-mL insulin syringe needle. The nail fold is divided into 2 halves and a maximum of 0.5 cc is injected in both halves or till there is swelling /edema of the nailfold. Injections are administered every 4 weeks until the end of treatment response, or for a maximum of 3 months', 'interventionNames': ['Drug: Intralesional triamcinolone acetonide and fluconazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical treatment with mometasone furoate and miconazole nitrate', 'description': 'Topical treatment in the form of twice daily application of combined steroid and antifungal (mometasone furoate and miconazole nitrate, Elica-M®) till the end of treatment response or for a maximum of 3 months.', 'interventionNames': ['Drug: Topical mometasone furoate and miconazole nitrate, Elica-M®']}], 'interventions': [{'name': 'Intralesional triamcinolone acetonide and fluconazole', 'type': 'DRUG', 'description': 'Triamcinolone acetonide and fluconazole in the ratio of 1:7, yielding a triamcinolone acetonide concentration of 5mg/ml, is injected through the affected nail fold with a 30-gauge, 1-mL insulin syringe needle.', 'armGroupLabels': ['Intralesional Triamcinolone acetonide and fluconazole']}, {'name': 'Topical mometasone furoate and miconazole nitrate, Elica-M®', 'type': 'DRUG', 'description': 'Topical treatment in the form of twice daily application of combined steroid and antifungal (mometasone furoate and miconazole nitrate, Elica-M®) till the end of treatment response or for a maximum of 3 months.', 'armGroupLabels': ['Topical treatment with mometasone furoate and miconazole nitrate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Yousra A Azzazi, Lecturer of Dermatology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Mohamed M El-Komy, Professor of Dermatology', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Habiba K Edrees, Dermatology Resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}, {'name': 'Khadija A Affify, Dermatology resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dermatology Specialist', 'investigatorFullName': 'Basant Ahmed Mohamed Abdelaal Helal', 'investigatorAffiliation': 'Cairo University'}}}}