Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT03602534
Status:
UNKNOWN
Last Update Posted:
2018-07-31
First Post:
2018-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thyroid Dysfunction in Female Patients With Acne Vulgaris: [ Relation to Other Variables ]
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples (serum)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-28', 'studyFirstSubmitDate': '2018-07-19', 'studyFirstSubmitQcDate': '2018-07-19', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thyroid hormone level in female acne vulgaris patients', 'timeFrame': '1 hour', 'description': 'Peripheral blood samples will be taken , for measurement of thyroid hormone by ELISA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acne vulgaris', 'thyroid dysfunction'], 'conditions': ['Acne Vulgaris', 'Thyroid Dysfunction']}, 'referencesModule': {'references': [{'pmid': '23210645', 'type': 'BACKGROUND', 'citation': 'Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013 Mar;168(3):474-85. doi: 10.1111/bjd.12149.'}, {'pmid': '20107754', 'type': 'BACKGROUND', 'citation': 'Zouboulis CC. [Acne vulgaris. The role of hormones]. Hautarzt. 2010 Feb;61(2):107-8, 110-4. doi: 10.1007/s00105-009-1830-1. German.'}, {'pmid': '25657324', 'type': 'BACKGROUND', 'citation': 'Contreras-Jurado C, Lorz C, Garcia-Serrano L, Paramio JM, Aranda A. Thyroid hormone signaling controls hair follicle stem cell function. Mol Biol Cell. 2015 Apr 1;26(7):1263-72. doi: 10.1091/mbc.E14-07-1251. Epub 2015 Feb 5.'}, {'pmid': '4361984', 'type': 'BACKGROUND', 'citation': 'Shuster S, Thody AJ. The control and measurement of sebum secretion. J Invest Dermatol. 1974 Mar;62(3):172-90. doi: 10.1111/1523-1747.ep12676782. No abstract available.'}, {'pmid': '21521376', 'type': 'BACKGROUND', 'citation': 'Vergou T, Mantzou E, Tseke P, Moustou AE, Katsambas A, Alevizaki M, Antoniou C. Association of thyroid autoimmunity with acne in adult women. J Eur Acad Dermatol Venereol. 2012 Apr;26(4):413-6. doi: 10.1111/j.1468-3083.2011.04084.x. Epub 2011 Apr 27.'}, {'pmid': '25771990', 'type': 'BACKGROUND', 'citation': 'Ekiz O, Balta I, Unlu E, Bulbul Sen B, Rifaioglu EN, Dogramaci AC. Assessment of thyroid function and lipid profile in patients with postadolescent acne in a Mediterranean population from Turkey. Int J Dermatol. 2015 Dec;54(12):1376-81. doi: 10.1111/ijd.12547. Epub 2015 Mar 13.'}, {'pmid': '6229881', 'type': 'BACKGROUND', 'citation': 'Thomson DB, Grammes CF, Starkey RH, Monsaert RP, Sunderlin FS. Thyroid abnormalities in patients previously treated with irradiation for acne vulgaris. South Med J. 1984 Jan;77(1):21-3. doi: 10.1097/00007611-198401000-00007.'}, {'pmid': '17542873', 'type': 'BACKGROUND', 'citation': 'Benjamin RW, Calikoglu AS. Hyperthyroidism and lupus-like syndrome in an adolescent treated with minocycline for acne vulgaris. Pediatr Dermatol. 2007 May-Jun;24(3):246-9. doi: 10.1111/j.1525-1470.2007.00395.x.'}, {'pmid': '27212279', 'type': 'BACKGROUND', 'citation': 'Uyar B, Solak A, Saklamaz A, Akyildiz M, Genc B, Gokduman A. Effects of isotretinoin on the thyroid gland and thyroid function tests in acne patients: A preliminary study. Indian J Dermatol Venereol Leprol. 2016 Sep-Oct;82(5):587-8. doi: 10.4103/0378-6323.182794.'}, {'pmid': '9248884', 'type': 'BACKGROUND', 'citation': 'Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.'}, {'pmid': '29484104', 'type': 'BACKGROUND', 'citation': 'Stewart TJ, Bazergy C. Thyroid autoimmunity in female post-adolescent acne: A case-control study. Dermatoendocrinol. 2017 Dec 12;9(1):e1405198. doi: 10.1080/19381980.2017.1405198. eCollection 2017. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Acne is a chronic inflammatory disease of the pilo-sebaceous unit with a multi-factorial etiology. It is one of the most frequent cutaneous diseases, affecting more than eighty percent of the population at some point in their lives .\n\nEndocrine factors especially androgens and steroids are one of multiple factors provoked to be involved in pathogenesis of acne . Thyroid hormones have steroid like action that have many regulatory functions in many body organ functions including skin and pilosebaceous unit. Furthermore, subtle thyroid dysfunction was shown to have a role in many disease conditions.\n\nThyroid hormone action on sebaceous glands is unclear. In hypothyroid states, sebocytes exhibit reduced rates of secretion that increases with thyroxine administration .', 'detailedDescription': 'Most of studies about thyroid dysfunction in acne patients focused on adult acne population especially females and searched for presence or absence of associating anti-thyroid antibodies with controversial results .\n\nSome other studies were concerned with the impact of acne treatments as tetracycline, isotretinoin or radiotherapy on thyroid pathologies and dysfunction .\n\nGlobal Acne Severity Scale (GAGS) is a simple, accurate, fast method for the determination of severity of acne, and it requires no special equipment and is relatively cost-effective. Its personal and interpersonal differences is low and it was first used by Doshi and his colleagues in 1997 in USA .\n\nTo the best of knowledge, little is published about thyroid dysfunction in acne female patients of different age categories and correlating thyroid function with other important patient and acne variables as body mass index (BMI) , age (starting from 16 years) , acne type, severity and duration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* multi centers in Assiut city\n* females only\n* age starts from 16 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with acne vulgaris from females only with different ages (starting from 16 years) , BMI groups.\n\nExclusion Criteria:\n\n* Female patients with clinically diagnosed thyroid disease.\n* Female patients receiving isotretinoin or minocycline in the last 6 months\n* Female patients who were subject to radiotherapy or surgery in neck region.'}, 'identificationModule': {'nctId': 'NCT03602534', 'briefTitle': 'Thyroid Dysfunction in Female Patients With Acne Vulgaris: [ Relation to Other Variables ]', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Thyroid Dysfunction in Female Patients With Acne Vulgaris: [ Relation to Other Variables ]', 'orgStudyIdInfo': {'id': 'TDFAV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cases with variable acne severity scores', 'description': '* group will include 50 females\n* Clinical examination including acne grade assessment using Global Acne Grading Scale (GAGS)\n* Assessment of body mass index (BMI)\n* blood serum samples will be collected from all patients to do thyroid function test'}, {'label': 'healthy controls', 'description': '* group will include 29 females\n* Assessment of body mass index (BMI)\n* blood serum samples will be collected from all healthy controls to do thyroid function test'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Reham Abdel-Gaber', 'role': 'CONTACT', 'email': 'rehamaher707@yahoo.com', 'phone': '01005043777'}], 'facility': 'DGamal', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Emad Taha', 'role': 'CONTACT', 'email': 'emadtaha76@yahoo.com', 'phone': '01006462294'}, {'name': 'Reham Abdel-Gaber', 'role': 'CONTACT', 'email': 'rehamaher707@yahoo.com', 'phone': '01005043777'}], 'overallOfficials': [{'name': 'Emad Taha', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Diana Gamal Esmat Fouad Botros', 'investigatorAffiliation': 'Assiut University'}}}}