Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-03-04 @ 8:18 PM
Study NCT ID:
NCT03081403
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2017-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative Sensory Testing in Subjects With Sensitive Skin or Not
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2017-03-10', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cutaneous perception threshold', 'timeFrame': '6 months', 'description': 'The cutaneous perception threshold of pain to heat.'}], 'secondaryOutcomes': [{'measure': 'The cutaneous perception threshold of vibration', 'timeFrame': '6 months', 'description': 'The cutaneous perception threshold of pain to harm.'}, {'measure': 'The cutaneous perception threshold of cold', 'timeFrame': '6 months', 'description': 'The cutaneous perception threshold of cold'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sensitive skin', 'Quantitative Sensory Testing'], 'conditions': ['Sensitive Skin']}, 'descriptionModule': {'briefSummary': 'Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have sensitive skin.\n\nThe Quantitative sensory testing (QST) is a physico-psychic method that uses gradients stimuli of different modalities to measure a subjective somatosensory response. This allows to characterize sensory dysfunction by assessing the participation of small and large nerve fibers.\n\nThe aim of this project is to characterize the presence or absence of a neurological disorder in patients with sensitive skin. This discovery would be a decisive argument to reinforce the suspicion that sensitive skins is linked to a small fiber neuropathy.', 'detailedDescription': 'Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have sensitive skin. A sensitive skin is characterized by the occurrence of tingling sensations, tightness, heat, burning, itching or pain triggered by non pathogenic factors such as wind, heat, cold, water , cosmetics, toiletries, stress...\n\nThe Quantitative sensory testing (QST) is a physico-psychic method that uses gradients stimuli of different modalities to measure a subjective somatosensory response. This allows to characterize sensory dysfunction by assessing the participation of small and large nerve fibers.\n\nThe aim of this project is to characterize the presence or absence of a neurological disorder in patients with sensitive skin. This discovery would be a decisive argument to reinforce the suspicion that sensitive skins is linked to a small fiber neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: between 20 and 60 years\n* Cooperating patient\n* Informed and written consent of the subject\n* Affiliated to the social security\n* For subjects with sensitive skin:\n\nsubjects with a score greater than 50 on the scale sensitive scale\n\n\\- To control subjects: subjects with result of less than 20 sensitive to the scale scale\n\nExclusion Criteria:\n\n* Adults subject with legal protection\n* Subject in a social institution.\n* Subject with major cognitive or psychiatric disorders\n* Subject with pathological use of alcohol or consumption of another drug.\n* Subject with skin involvement of the back of the dominant hand or malformation.\n* Known sensitive neuropathy\n* Pregnant woman\n* Subject receiving medical treatment which may interfere with the results.\n* Subject with treatment in the back of the dominant hand.'}, 'identificationModule': {'nctId': 'NCT03081403', 'acronym': 'SENSISKIN', 'briefTitle': 'Quantitative Sensory Testing in Subjects With Sensitive Skin or Not', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Quantitative Sensory Testing in Subjects With Sensitive Skin or Not', 'orgStudyIdInfo': {'id': 'SENSISKIN 29CRB16.0100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Subjects with sensitive skin', 'description': 'Subjects with a score greater than 50 on the sensitive scale', 'interventionNames': ['Device: Quantitative Sensory Testing']}, {'type': 'OTHER', 'label': 'Subjects without sensitive skin', 'description': 'Subjects with result lower than 20 on the sensitive scale', 'interventionNames': ['Device: Quantitative Sensory Testing']}], 'interventions': [{'name': 'Quantitative Sensory Testing', 'type': 'DEVICE', 'description': 'Study of detection thresholds of vibration, cold and pain related to the heat in the dominant hand of the subjects through the QST.', 'armGroupLabels': ['Subjects with sensitive skin', 'Subjects without sensitive skin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}