Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT04660916
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2020-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Isotretinoin on the Growth Rate and Thickness of the Nail Plate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009264', 'term': 'Nails, Malformed'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015474', 'term': 'Isotretinoin'}], 'ancestors': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-03', 'studyFirstSubmitDate': '2020-11-28', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The lengths and thicknesses of nail plate according to months in the isotretinoin group', 'timeFrame': '30 days', 'description': 'These are the measures of monthly nail growth rates and thicknesses of nail plate. The lengths and thicknesses of nail plate are recorded in millimeters. Results are presented as mean or median according to whether they are normally distributed or not.'}, {'measure': 'The lengths and thicknesses of nail plate according to months in the control group', 'timeFrame': '30 days', 'description': 'These are the measures of monthly nail growth rates and thicknesses of nail plate. The lengths and thicknesses of nail plate are recorded in millimeters. Results are presented as mean or median according to whether they are normally distributed or not.'}, {'measure': 'Comparison of nail growth rate according to groups', 'timeFrame': '30 days', 'description': 'This is the comparison of monthly nail growth rates according to groups. The values of nail growth rates are recorded in millimeters per month.'}, {'measure': 'Comparison of nail thickness according to groups', 'timeFrame': '30 days', 'description': 'This is the comparison of monthly nail thickness according to groups. The values of nail thickness are recorded in millimeters.'}, {'measure': 'The effect of group on the change in growth rate of nail plate by time', 'timeFrame': '30 days', 'description': 'It is investigated using repeated measures analysis of variance'}, {'measure': 'The effect of group on the change in thickness of nail plate by time', 'timeFrame': '30 days', 'description': 'It is investigated using repeated measures analysis of variance'}, {'measure': 'Changes in nail growth rates by time in the isotretinoin group', 'timeFrame': '30 days', 'description': 'It is investigated using repeated measures analysis of variance'}, {'measure': 'Changes in nail thickness by time in the isotretinoin group', 'timeFrame': '30 days', 'description': 'It is investigated using repeated measures analysis of variance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['isotretinoin', 'nail growth rate', 'nail thickness', '13-cis-retinoic acid'], 'conditions': ['Isotretinoin', 'Nail Abnormality']}, 'descriptionModule': {'briefSummary': "The nail is an important skin appendage which can provide information about the person's overall health status in addition to having several important functions such as protection, tactile sensation, grasping. Many nail abnormalities which can have considerable psychological impact are side effects of drug administration. Retinoids have various effects on nails. Although isotretinoin as a retinoid has been associated with both decreased and increased nail growth, the great majority of such associations are not evidence-based. So, it was aimed to investigate the effects of isotretinoin on morphology, growth rate, and thickness of the nail plate.", 'detailedDescription': "Isotretinoin has various side effects that affect many organ systems. Some side effects such as nail changes, which do not require treatment cessation, can limit the use of isotretinoin by impairing the patient's quality of life. Although it is known that isotretinoin has various effects on the nails, there is very limited data on effects of isotretinoin on the nails. Therefore, it was aimed to investigate the effect of isotretinoin on the morphology, growth rate, and thickness of the nail plate. The patients aged 18-45 that were planned to begin treatment with isotretinoin for acne in the outpatient clinic and a control group consisting of healthy volunteers are planned to be included in the study. A dermatological examination of skin and nails is conducted in all participants. Isotretinoin treatment at 0.5 mg/kg per day in 2 divided doses will be started to patients with acne. The length and thickness of nail plate are measured by digital caliper before isotretinoin treatment, and repeated during the control visits of the participants at 30 day intervals for 6 months. All the examination and measurements are carried out in both groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All participants who are admitted to the outpatient clinic of our tertiary referral hospital were planned to include in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients that were planned to begin treatment with isotretinoin for acne\n\nExclusion Criteria:\n\n* Having known diseases (dermatological or systemic disorders) affecting the growth rate and thickness of nail plate\n* Using systemic or topical drugs with known effects on nail\n* Having traumatic nail abnormalities (onychotillomania, nail biting, habit-tic deformity)\n* Having no visible lunula\n* Describing any trauma (including cutting or filing nails) between the two measurements'}, 'identificationModule': {'nctId': 'NCT04660916', 'briefTitle': 'Effects of Isotretinoin on the Growth Rate and Thickness of the Nail Plate', 'organization': {'class': 'OTHER', 'fullName': 'Balikesir University'}, 'officialTitle': 'Effects of Isotretinoin on the Morphology, Growth Rate, and Thickness of the Nail Plate', 'orgStudyIdInfo': {'id': '19AKD93'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'isotretinoin', 'description': 'The patients aged 18-45 that were planned to begin treatment with isotretinoin for acne', 'interventionNames': ['Drug: Isotretinoin']}, {'label': 'control', 'description': 'Healthy volunteers aged 18-45 without any diseases/drugs affecting the nail'}], 'interventions': [{'name': 'Isotretinoin', 'type': 'DRUG', 'otherNames': ['Roaccutane', 'Zoretanin', 'D10BA01'], 'description': 'The effects of isotretinoin on morphology, growth rate, and thickness of the nail plate', 'armGroupLabels': ['isotretinoin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10145', 'city': 'Balıkesir', 'country': 'Turkey (Türkiye)', 'facility': 'Balikesir University', 'geoPoint': {'lat': 39.64917, 'lon': 27.88611}}], 'overallOfficials': [{'name': 'Sinan Özçelik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balıkesir Üniversitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinan Özçelik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sinan Özçelik', 'investigatorAffiliation': 'Balikesir University'}}}}