Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT06923202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Alloknesia in Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alloknesia diagnostic questionnaire', 'timeFrame': 'Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.', 'description': "The questionnaire consists of a single question: 'Can the touch of your skin by clothing, air movements or the light touch of an object or another person trigger itching?"}], 'secondaryOutcomes': [{'measure': 'WI-NRS scale', 'timeFrame': 'Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.', 'description': 'Digital pruritus scale, measuring the worst daily itching intensity'}, {'measure': 'ItchyQoL questionnaire', 'timeFrame': 'Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.', 'description': 'Itch-related quality of life'}, {'measure': 'DLQI (Dermatology Life Quality Index) questionnaire', 'timeFrame': 'Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.', 'description': 'Skin-related quality of life'}, {'measure': 'HADS (Hospital Anxiety and Depression Scale) questionnaire', 'timeFrame': 'Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.', 'description': 'The HAD scale is an instrument for screening for anxiety and depressive disorders.'}, {'measure': 'Stigmatisation : PUSH-D questionnaire', 'timeFrame': 'Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.', 'description': 'PUSH-D allows a comprehensive view of the degree of stigmatization in visible skin disorders.'}, {'measure': 'Stress perçu : PSS (Perceived Stress Scale)', 'timeFrame': 'Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.', 'description': 'The PSS (Perceived Stress Scale) is a scale for measuring perceived stress.'}, {'measure': 'Insomnia: Epworth questionnaire', 'timeFrame': 'Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.', 'description': 'The Epworth Test is a self-administered questionnaire that assesses subjective sleepiness and fatigue.'}, {'measure': 'ISS (Sexual Satisfaction Index) questionnaire', 'timeFrame': 'Day of inclusion. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.', 'description': 'Satisfaction with sexual relations'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatosis', 'Alloknesie']}, 'referencesModule': {'references': [{'pmid': '1798888', 'type': 'BACKGROUND', 'citation': 'Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.'}, {'pmid': '8033378', 'type': 'BACKGROUND', 'citation': 'Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.'}, {'pmid': '32936233', 'type': 'BACKGROUND', 'citation': 'Kimel M, Zeidler C, Kwon P, Revicki D, Stander S. Validation of Psychometric Properties of the Itch Numeric Rating Scale for Pruritus Associated With Prurigo Nodularis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2020 Dec 1;156(12):1354-1358. doi: 10.1001/jamadermatol.2020.3071.'}]}, 'descriptionModule': {'briefSummary': 'Alloknesia is defined as pruritus (= itching) triggered by light mechanical stimuli, which are responsible for the perception of light touch under physiological conditions, but which are perceived as pruritic under pathological conditions. Alloknesia occurs mainly in the context of chronic pruritus. Consequently, patients suffering from chronic pruritus frequently perceive light touch sensations as pruritic, which can be particularly unpleasant and alter human interactions and quality of life on a daily basis. However, the epidemiology and burden of alloknesia have never been studied, whatever the cause of chronic pruritus.\n\nAtopic dermatitis is one of the main diseases causing chronic itching, and patients frequently complain of alloknesia.\n\nIn this study, we aim to investigate the frequency of alloknesia in patients with atopic dermatitis and to measure the consequences of alloknesia in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with atopic dermatitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* No opposition from the patient\n* Diagnosis of atopic dermatitis more than 6 months old\n\nExclusion Criteria:\n\n* Patients who are physically or mentally unable to complete the questionnaires.\n* Patients on systemic treatment for 1 month or more\n* Refusal to participate\n* Patients under legal protection (guardianship, curatorship)\n* Patients under court protection'}, 'identificationModule': {'nctId': 'NCT06923202', 'acronym': 'ALLOKNESIE', 'briefTitle': 'Study of Alloknesia in Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Study of Alloknesia in Atopic Dermatitis', 'orgStudyIdInfo': {'id': '29BRC24.0355'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with atopic dermatitis', 'description': 'Patients will take part in the study on a single occasion, during which they will complete the various questionnaires (Alloknesia diagnostic questionnaire, WI-NRS scale, ItchyQol questionnaire, DLQI questionnaire, HADS questionnaire, PUSH-D questionnaire, PSS (Perceived Stress Scale), Epworth questionnaire, ISS questionnaire). There will be no follow-up.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Laurent MISERY, PUPH', 'role': 'CONTACT', 'email': 'laurent.misery@chu-brest.fr', 'phone': '02 98 22 33 15'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after the publication of result and ending fifteen years following the last visit of the last patient', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'collaborators': [{'name': 'Almirall, S.A.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}