Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 4:14 AM
Study NCT ID:
NCT07331792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-12
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Efficacy of Topical 1% Clotrimazole vs Oral Itraconazole in the Treatment of Pityriasis Versicolor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014010', 'term': 'Tinea Versicolor'}], 'ancestors': [{'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': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentile efficacy of topical versus oral antifungal in the treatment of pityriasis versicolor', 'timeFrame': '3 months', 'description': 'Data analysis will be performed using SPSS version 20. The quantitative variable (age, BMI and duration of PV) will be presented as mean ± standard deviation (SD) or median interquartile range (IQR) after checking normality of data by using Shapiro-Wilk test. Frequency and percentages will be used for categorical variables (gender, severity of PV, area of residence, level of education and efficacy). Efficacy will be compared between groups using Chi-square or Fisher exact test. Efficacy will be stratified by age, gender, BMI, duration of PV and severity of PV to deal with effect modifiers. Post-stratification chi-square test or Fischer exact test will be used as test of significance. A p-value of ≤ 0.05 will be considered statistically significant.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pityriasis Versicolor']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Bamford JTM, Flores-GenuinoRNS, Ray S, Bigby M, Morales-Sánchez MA, Arkoncel M, et al. Interventions for the treatment of pityriasis versicolor. Cochrane Database Syst Rev. 2018;2018(6):CD011208. https://doi.org/10.1002/14651858.CD011208.pub2'}, {'pmid': '39079943', 'type': 'BACKGROUND', 'citation': 'Hill RC, Faria W, Gold JAW, Lipner SR. Factors associated with pityriasis versicolor in a large national database. Mycoses. 2024 Aug;67(8):e13775. doi: 10.1111/myc.13775.'}, {'pmid': '35751534', 'type': 'BACKGROUND', 'citation': 'Kurniadi I, Hendra Wijaya W, Timotius KH. Malassezia virulence factors and their role in dermatological disorders. Acta Dermatovenerol Alp Pannonica Adriat. 2022 Jun;31(2):65-70.'}, {'pmid': '36452877', 'type': 'BACKGROUND', 'citation': 'Leung AK, Barankin B, Lam JM, Leong KF, Hon KL. Tinea versicolor: an updated review. Drugs Context. 2022 Nov 14;11:2022-9-2. doi: 10.7573/dic.2022-9-2. eCollection 2022.'}, {'pmid': '37895478', 'type': 'BACKGROUND', 'citation': 'Labedz N, Navarrete-Dechent C, Kubisiak-Rzepczyk H, Bowszyc-Dmochowska M, Pogorzelska-Antkowiak A, Pietkiewicz P. Pityriasis Versicolor-A Narrative Review on the Diagnosis and Management. Life (Basel). 2023 Oct 22;13(10):2097. doi: 10.3390/life13102097.'}]}, 'descriptionModule': {'briefSummary': 'Comparative efficacy of topical 1% clotrimazole vs oral itraconazole in the treatment of pityriasis versicolor -Randomized control trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age (15-50 years)\n* Both genders\n* Sufferers of Pityriasis versicolor ( Determined by scale , erythema and pruritus)\n\nExclusion Criteria:\n\n* Pt with history of antifungals in last one month\n* Pt on immunosuppressants or steroid therapy\n* Pregnant and lactating women\n* Pt with chronic medical conditions ( Diabetes and hypertension)'}, 'identificationModule': {'nctId': 'NCT07331792', 'briefTitle': 'Comparative Efficacy of Topical 1% Clotrimazole vs Oral Itraconazole in the Treatment of Pityriasis Versicolor', 'organization': {'class': 'OTHER', 'fullName': 'Combined Military Hospital Abbottabad'}, 'officialTitle': 'Comparative Efficacy of Topical 1% Clotrimazole vs Oral Itraconazole in the Treatment of Pityriasis Versicolor', 'orgStudyIdInfo': {'id': 'CMH-Atd-ETH-200-Derm-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1% Clotrimazole', 'description': 'topical 1 % clotrimazole twice daily for 2 weeks', 'interventionNames': ['Drug: Topical 1 % clotrimazole twice daily 2 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Itraconazole', 'description': 'Oral itraconazole 200mg daily 5 days', 'interventionNames': ['Drug: Oral itraconazole 200mg daily for 5 days']}], 'interventions': [{'name': 'Topical 1 % clotrimazole twice daily 2 weeks', 'type': 'DRUG', 'description': 'Topical 1% clotrimazole twice daily for 2 weeks', 'armGroupLabels': ['1% Clotrimazole']}, {'name': 'Oral itraconazole 200mg daily for 5 days', 'type': 'DRUG', 'description': 'Oral itraconazole 200mg daily for 5 days', 'armGroupLabels': ['Itraconazole']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zaeema Aman, MBBS', 'role': 'CONTACT', 'email': 'zaeema.aman@gmail.com', 'phone': '+923200400726'}, {'name': 'Ali Amar, MBBS, FCPS', 'role': 'CONTACT', 'email': 'docaliamar@gmail.com', 'phone': '+923215625426'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Combined Military Hospital Abbottabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resisent Dermatology', 'investigatorFullName': 'Zaeema Aman', 'investigatorAffiliation': 'Combined Military Hospital Abbottabad'}}}}