Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-27 @ 2:50 PM
Study NCT ID:
NCT06189768
Status:
COMPLETED
Last Update Posted:
2024-01-08
First Post:
2023-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Pigmentation Disorders in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017495', 'term': 'Hyperpigmentation'}], 'ancestors': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2023-12-30', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the causes of hyperpigmentation in children aged 0 to 15', 'timeFrame': '1.5 years', 'description': "Measure the prevalence of different causes of hyperpigmentation due to any cause in children aged 0 to 15 years presenting to the dermatology outpatient department of Kanti Children's Hospital. Outpatient hospital records were used for collecting the study variables."}, {'measure': 'Measure the age distribution of children with hyperpigmentation disorders', 'timeFrame': '1.5 years', 'description': "The age (in years) of all the children with hyperpigmentation disorders presenting to the outpatient department of Kanti Children's Hospital was recorded. Outpatient hospital records were used for collecting the study variable."}, {'measure': 'Measure the gender distribution of children with hyperpigmentation disorders', 'timeFrame': '1.5 years', 'description': "The gender (male or female) of all the children with hyperpigmentation disorders presenting to the outpatient department of Kanti Children's Hospital was recorded. Outpatient hospital records were used for collecting the study variable."}, {'measure': 'Measure the caste distribution of children with hyperpigmentation disorders', 'timeFrame': '1.5 years', 'description': "The caste of all the children with hyperpigmentation disorders presenting to the outpatient department of Kanti Children's Hospital was recorded. Outpatient hospital records were used for collecting the study variable."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperpigmentation disorders', 'Nepal', 'Pediatric', 'Observational study'], 'conditions': ['Hyperpigmentation', 'Pediatric Dermatology']}, 'descriptionModule': {'briefSummary': "The descriptive cross-sectional study was undertaken at Kanti Children's Hospital during the period from January 2020 to June 2021. Ethical approval for the study was obtained from the Institutional Review Board of Kanti Children's Hospital (IRB-KCH). The refence number is 59/2020-021. The study focused on children with hyperpigmentation disorders presenting at the Dermatology Outpatient Department of Kanti Children's Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusive of children ranging from newborns to 15 years old with hyperpigmentation due to any cause, the study excluded those admitted to wards with alternative diagnoses', 'genderDescription': 'Inclusive of children ranging from newborns to 15 years old with hyperpigmentation due to any cause, the study excluded those admitted to wards with alternative diagnoses.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children ranging from newborns to 15 years old with hyperpigmentation due to any cause\n\nExclusion Criteria:\n\n* children admitted to wards'}, 'identificationModule': {'nctId': 'NCT06189768', 'briefTitle': 'A Study on Pigmentation Disorders in Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nepal Health Research Council'}, 'officialTitle': "A Retrospective Study on Pigmentation Disorders in Children in a Tertiary Care Children's Hospital.", 'orgStudyIdInfo': {'id': '59/2020-021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with hyperpigmentation disorder', 'description': "Children aged 0 to 15 with hyperpigmentation due to any cause presenting to Dermatology Outpatient Department of Kanti Children's Hospital"}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kathmandu', 'country': 'Nepal', 'facility': "Kanti Children's Hospital", 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nepal Health Research Council', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Abal Baral', 'investigatorAffiliation': 'Nepal Health Research Council'}}}}