Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT05634460
Status:
COMPLETED
Last Update Posted:
2022-12-02
First Post:
2022-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008976', 'term': 'Molluscum Contagiosum'}], 'ancestors': [{'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C029943', 'term': 'potassium hydroxide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-22', 'studyFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2022-11-22', 'lastUpdatePostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '. Efficacy was classified as follows: • complete remission (≥ 90% clearance of lesions) • partial remission (60-90% clearance of lesions) • insignificant improvement (<60% clearance of lesions)', 'timeFrame': '06 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['potassium hydroxide 5% and 10% lotion'], 'conditions': ['Molluscum Contagiosum']}, 'descriptionModule': {'briefSummary': 'Molluscum is a virus-related skin infestation which is commonly seen among children. Molluscipox virus, the largest human virus, causes it. MC typically manifests as a single or multiple dome-shaped, shiny, pearly white papules with a central dimple. In immunocompetent individuals, spontaneous resolution usually occurs within 18 months; however, the lesion may persist for several years. Asymptomatic lesions are common. It is also linked to a high risk of transmission and an increasing prevalence in global populations1-2.\n\nPatients may receive therapy for social and cosmetic reasons, and also to avoid spreading disease to others. Numerous modalities are currently available, including Potassium hydroxide, curettage, cryotherapy, disinfected needle pricking, photodynamic therapy, laser, salicylic acid, glycolic acid etc3-4.\n\nPotassium hydroxide (KOH) is a topical treatment for Molluscum contagiosum. Dermatologists routinely use potassium hydroxide (KOH) in varying concentrations to identify fungal elements. Because it is a strong alkali with keratolytic characteristics, variable concentrations given for management of MC. Because it is inexpensive and widely accessible, it has the potential to be a useful method for treating for MC in resource-constrained countries5-6.\n\nThe purpose of this study is to examine two varied concentrations of Potassium hydroxide (5%-KOH vs 10%-KOH) among MC patients in order to determine the most effective KOH concentration to manage Molluscum Contagiosum among children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria \\<100 lesions no therapy within the earlier one month\n\nExclusion Criteria:\n\nknown hypersensitivity and immunodeficiency'}, 'identificationModule': {'nctId': 'NCT05634460', 'briefTitle': 'Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum', 'organization': {'class': 'OTHER', 'fullName': 'Combined Military Hospital Abbottabad'}, 'officialTitle': 'Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum', 'orgStudyIdInfo': {'id': 'CMHAtd-ETH-04-Derm-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'patients in group A treated with 5% potassium hydroxide on every lesion once daily via cotton-tipped applicator for at least two weeks or till inflammatory manifestations', 'interventionNames': ['Drug: potassium hydroxide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'patients in group B treated with10% potassium hydroxide on every lesion once daily via cotton-tipped applicator for at least two weeks or till inflammatory manifestations', 'interventionNames': ['Drug: potassium hydroxide']}], 'interventions': [{'name': 'potassium hydroxide', 'type': 'DRUG', 'description': 'Potassium hydroxide (KOH) is a topical treatment for Molluscum contagiosum. Dermatologists routinely use potassium hydroxide (KOH) in varying concentrations to identify fungal elements. Because it is a strong alkali with keratolytic characteristics, variable concentrations given for management of MC.', 'armGroupLabels': ['Group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22010', 'city': 'Abbottabad', 'state': 'KPK', 'country': 'Pakistan', 'facility': 'CMH', 'geoPoint': {'lat': 34.1463, 'lon': 73.21168}}], 'overallOfficials': [{'name': 'Bushra Muzaffar, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Combined Military Hospital Abbottabad'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Combined Military Hospital Abbottabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Huma Farid', 'investigatorFullName': 'Huma Farid', 'investigatorAffiliation': 'Combined Military Hospital Abbottabad'}}}}