Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT04555018
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2020-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Dehydroepiandrosterone Sulfate and Sebum Level in Adult Female Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-17', 'studyFirstSubmitDate': '2020-09-14', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sebum level', 'timeFrame': 'One day', 'description': 'Using sebumeter to evaluate the sebum level objectively'}, {'measure': 'Dehydroepiandrosterone sulfate', 'timeFrame': 'One day', 'description': 'Blood serum was used to evaluate Dehydroepiandrosterone sulfate level.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acne vulgaris', 'Sebum level', 'Dehydroepiandrosterone Sulfate'], 'conditions': ['Acne Vulgaris', 'Female']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the correlation between Dehydroepiandrosterone sulfate (DHEAS) and sebum level in adult female acne. A cross sectional study was conducted with 50 samples, in June to October 2017.', 'detailedDescription': 'Epidemiological studies have shown that number of adult female acne vulgaris (AV) increases. Hormone, sebum production, Propionibacterium acne and inflammatory process are factors involved in AV development. The aim of this study is to determine the correlation between Dehydroepiandrosterone sulfate (DHEAS) and sebum level in adult female acne. This research used cross sectional study with 50 samples, aged 25-49 years by consecutive sampling. The degree of acne vulgaris was evaluated using Lehman criteria , and then the sebum level and DHEAS were measured objectively using sebumeter and serum, respectively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '25 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female , age 25-29 years, diagnosed with mild to severe acne vulgaris', 'genderDescription': 'Female', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, age 25-29 years\n* Diagnosed with mild to severe acne vulgaris\n* Agree to participate\n\nExclusion Criteria:\n\n* History of taking antiandrogen drugs\n* History of taking oral and topical antibiotics, using topical retinoid and BPO in the last 4 weeks\n* History of taking oral isotretinoin in the last 6 months\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04555018', 'briefTitle': 'Correlation Between Dehydroepiandrosterone Sulfate and Sebum Level in Adult Female Acne Vulgaris', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Correlation Between Dehydroepiandrosterone Sulfate and Sebum Level in Adult Female Acne Vulgaris', 'orgStudyIdInfo': {'id': 'DheasSebum'}}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'Jakarta Pusat', 'country': 'Indonesia', 'facility': 'Indonesia dr. Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Irma B Sitohang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr.dr.Irma Bernadette, SpKK (K)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Irma Bernadette S. Sitohang, MD, PhD - Head of Division of Cosmetic Dermatology, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia', 'investigatorFullName': 'Dr.dr.Irma Bernadette, SpKK (K)', 'investigatorAffiliation': 'Indonesia University'}}}}