Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT07136467
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Real World Study to Globally Assess Disease Burden in Adolescent and Adult Participants With Alopecia Areata, Vitiligo, or Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}, {'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2795}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alopecia Areata (AA) symptoms affecting quality of life and daily functioning, assessed by the Alopecia Areata Symptom Impact Scale (AASIS) AA only', 'timeFrame': 'Up to Day 1', 'description': 'AASIS- is a scale assessing the severity of AA-related symptoms on daily functioning. Each item scored on a 0-10 Likert scale, where 0 = not present and 10 = as bad as you can imagine Higher total score = greater impact'}, {'measure': 'Measuring scalp hair loss, assessed by the Severity of Alopecia Tool (SALT) score. AA only', 'timeFrame': 'Up to Day 1', 'description': 'SALT is a Tool developed to quantify AA-related hair loss Total score of 0-100, with 0 = no hair loss, and 100 = complete hair loss'}, {'measure': 'Measuring facial skin depigmentation, assessed by the Facial Vitiligo Area Scoring Index (F-VASI) Vitiligo Only', 'timeFrame': 'Up to Day 1', 'description': 'F-VASI is a quantitative scoring tool used to evaluate the extent and severity of facial vitiligo calculated by multiplying the degree of skin depigmentation of the face'}, {'measure': 'Vitiligo Quality of Life (QOL), assessed by Vitiligo Quality of Life Score (VitiQoL) Vitiligo Only', 'timeFrame': 'Up to Day 1', 'description': 'VitiQoL is a 16-item instrument assessing impact of vitiligo on QoL. 15 items are scored on a 7-point Likert scale, ranging from "not at all" to "all the time". An additional item (not contributing to total score) assesses current severity of condition on a 7-point scale ranging from "no skin involvement" to "most severe case"'}, {'measure': "Hidradenitis Suppurativa (HS) Quality of Life (QOL), assessed by Dermatology Life Quality Index (DLQI)/Children's Dermatology Life Quality Index (CDLQI) HS only", 'timeFrame': 'Up to Day 1', 'description': 'CDLQI is a10-question index measuring health-related quality of life (HRQoL) over the last 7 days for patients suffering from a skin disease. The DLQI is used in participants aged 16 and over and the CDLQI has been validated from the ages of 4 to 16 years. Each item scored on a 4-point Likert scale, where 0 = not at all/not relevant/question unanswered and 3 = very much. Maximum total score = 30 (highest impact on QoL).'}, {'measure': 'Measuring disease severity, assessed by the International Hidradenitis Suppurativa Severity Scoring System (IHS4) HS only', 'timeFrame': 'Up to Day 1', 'description': 'The IHS4 score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Segmental Vitiligo (NSV)', 'Alopecia Areata', 'Hidradenitis Suppurativa'], 'conditions': ['Non-Segmental Vitiligo (NSV)', 'Alopecia Areata', 'Hidradenitis Suppurativa']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=H25-663', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study is to assess the burden of disease in adolescent and adult participants with moderate or severe alopecia areata (AA), non-segmental vitiligo (NSV), or moderate to severe hidradenitis suppurativa (HS) in a large global real-world participant population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescent and Adult Participants with Alopecia Areata, Vitiligo, or Hidradenitis Suppurativa in Real-World will undergo a single-visit data collection per routine clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with Physician-confirmed diagnosis of non-segmental vitiligo (NSV), moderate to severe Alopecia Areata (AA), or moderate to severe hidradenitis suppurativa (HS)\n* Participants Ability to understand study questionnaires, with caregiver support as required for adolescents\n\nExclusion Criteria:\n\n* Participating in interventional clinical trial(s) at time of study visit (participation in another non-interventional study or registry does not exclude a participant from this study)\n* Unable or unwilling to comply with study requirements and PRO collection'}, 'identificationModule': {'nctId': 'NCT07136467', 'acronym': 'MEASUREAAVitHS', 'briefTitle': 'A Real World Study to Globally Assess Disease Burden in Adolescent and Adult Participants With Alopecia Areata, Vitiligo, or Hidradenitis Suppurativa', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Multi-Country, Cross-sectional Study to Characterize Real World Burden of Disease in Adolescent and Adult Patients With Alopecia Areata, Vitiligo or Hidradenitis Suppurativa (MEASURE AAVitHS)', 'orgStudyIdInfo': {'id': 'H25-663'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Vitiligo', 'description': 'Participants with vitiligo will undergo a single-visit data collection per routine clinical practice'}, {'label': 'Participants with Alopecia Areata', 'description': 'Participants with alopecia areata will undergo a single-visit data collection per routine clinical practice'}, {'label': 'Participants with Hidradenitis Suppurativa', 'description': 'Participants with hidradenitis suppurativa will undergo a single-visit data collection per routine clinical practice'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1055', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Buenos Aires Skin /ID# 277637', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1061', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 277634', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1181', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires /ID# 277636', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1425', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Instituto de Neumonología y Dermatología /ID# 277635', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'T5N 1L5', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Alberta Dermatology Consultants /ID# 277187', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L4M 7G1', 'city': 'Barrie', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Simcoderm Medical And Surgical Dermatology Centre /ID# 276838', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'N6H 5L5', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'DermEffects /ID# 276594', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L3P 1X2', 'city': 'Markham', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Lynderm Research Inc /ID# 276595', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'L4C 9M7', 'city': 'Richmond Hill', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'York Dermatology Clinic & Research Centre /ID# 276697', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': '323 00', 'city': 'Pilsen', 'state': 'Plzeň Region', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '+420 377 534 145'}], 'facility': 'Dermafit Centrum /ID# 275863', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '13419', 'city': 'Tallinn', 'state': 'Harju', 'status': 'RECRUITING', 'country': 'Estonia', 'facility': 'North Estonia Medical Centre /ID# 276933', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '21000', 'city': 'Dijon', 'state': 'Bourgogne-Franche-Comté', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu Dijon /Id# 277493', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '25000', 'city': 'Besançon', 'state': 'Doubs', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Besançon - Hôpital Jean Minjoz /ID# 277459', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'state': 'Gironde', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 277322', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'state': 'Indre-et-Loire', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 277545', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '56322', 'city': 'Lorient', 'state': 'Morbihan', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier de Bretagne Sud /ID# 277559', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '57085', 'city': 'Metz', 'state': 'Moselle', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy /ID# 277792', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '87000', 'city': 'Limoges', 'state': 'Nouvelle-Aquitaine', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Limoges - Dupuytren 2 /ID# 277323', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69100', 'city': 'Villeurbanne', 'state': 'Rhone', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Médipôle Lyon-Villeurbanne /ID# 277526', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}, {'zip': '76290', 'city': 'Montivilliers', 'state': 'Seine-Maritime', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Groupe Hospitalier Du Havre - Hôpital Jacques Monod /ID# 277506', 'geoPoint': {'lat': 49.54518, 'lon': 0.18769}}, {'zip': '90400', 'city': 'Trévenans', 'state': 'Territoire De Belfort', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Nord Franche-Comté /ID# 277560', 'geoPoint': {'lat': 47.56667, 'lon': 6.86667}}, {'zip': '83800', 'city': 'Toulon', 'state': 'Var', 'status': 'RECRUITING', 'country': 'France', 'facility': "Hôpital d'Instruction des Armées Sainte-Anne /ID# 277458", 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'state': 'Vendee', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Departemental Vendee (Chd Vendee) /ID# 277317', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '62100', 'city': 'Calais', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier de Calais /ID# 277320', 'geoPoint': {'lat': 50.95194, 'lon': 1.85635}}, {'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Cideazur /ID# 277316', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre De Santé Sabouraud /ID# 278409', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75674', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint-Joseph /ID# 278270', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Rennes - Hôpital PONTCHAILLOU /ID# 277527', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '97400', 'city': 'Saint-Denis', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU de la reunion /ID# 277318', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '94163', 'city': 'Saint-Mandé', 'status': 'RECRUITING', 'country': 'France', 'facility': "Hôpital d'Instruction des Armées Bégin /ID# 278135", 'geoPoint': {'lat': 48.83864, 'lon': 2.41579}}, {'zip': '76133', 'city': 'Karlsruhe', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Derma Sana /ID# 279254', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '86150', 'city': 'Augsburg', 'state': 'Bavaria', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Virgil Oreste Mihaescu /ID# 279229', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '97437', 'city': 'Haßfurt', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Hautarztpraxis Hassberge Dr. Boris Bauer /ID# 279272', 'geoPoint': {'lat': 50.03521, 'lon': 10.5156}}, {'zip': '93309', 'city': 'Kelheim', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Dr. Neumann /ID# 279255', 'geoPoint': {'lat': 48.91725, 'lon': 11.88618}}, {'zip': '95326', 'city': 'Kulmbach', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Dermakulm /Id# 279126', 'geoPoint': {'lat': 50.10068, 'lon': 11.45032}}, {'zip': '49565', 'city': 'Bramsche', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 279210', 'geoPoint': {'lat': 52.40881, 'lon': 7.97288}}, {'zip': '48683', 'city': 'Ahaus', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Hautarztliche Gemeinschaftspraxis Dres. med. Petri & Mocklinghoff /ID# 279230', 'geoPoint': {'lat': 52.07936, 'lon': 7.01344}}, {'zip': '45964', 'city': 'Gladbeck', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Hautarztpraxis Shirin Samimi-Fard & Elena Dippel /ID# 279232', 'geoPoint': {'lat': 51.57077, 'lon': 6.98593}}, {'zip': '41061', 'city': 'Mönchengladbach', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'ZENTderma /ID# 279235', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'zip': '42897', 'city': 'Remscheid', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Dariusch Mortazawi /ID# 279214', 'geoPoint': {'lat': 51.17983, 'lon': 7.1925}}, {'zip': '55128', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 279271', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '66663', 'city': 'Merzig', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'HMS GmbH Zimmer /ID# 279211', 'geoPoint': {'lat': 49.44331, 'lon': 6.63874}}, {'zip': '06108', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Abdou Zarzour /ID# 279125', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '07548', 'city': 'Gera', 'state': 'Thuringia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Dirk Lange /ID# 279215', 'geoPoint': {'lat': 50.88029, 'lon': 12.08187}}, {'zip': '65520', 'city': 'Bad Camberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'MVZ medicum.mittelhessen /ID# 279136', 'geoPoint': {'lat': 50.29695, 'lon': 8.26896}}, {'zip': '04317', 'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Hautarztpraxis Dr. Med. Ulrike Wiemers / Dr. Med. Franca Wiemers /ID# 279124', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '58332', 'city': 'Schwelm', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Hautarztpraxis Schwelm /ID# 279140', 'geoPoint': {'lat': 51.28635, 'lon': 7.29388}}, {'zip': '83512', 'city': 'Wasserburg A. Inn', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Praxis Dehmel / Brand-Opitzer /ID# 279351'}, {'zip': '65185', 'city': 'Wiesbaden', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Dr. med. Nicola Möller & Thomas Kurtenbach GbR Dermatologie im Zentrum /ID# 279137', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '18536', 'city': 'Piraeus', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'Tzaneio Prefecture General Hospital of Piraeus /ID# 276881', 'geoPoint': {'lat': 37.94203, 'lon': 23.64619}}, {'zip': '41110', 'city': 'Larissa', 'state': 'Larisa', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'The University Hospital of Larissa /ID# 277234', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '44124', 'city': 'Cona', 'state': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 276986', 'geoPoint': {'lat': 44.80583, 'lon': 11.7069}}, {'zip': '70124', 'city': 'Bari', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'facility': 'A.O.U. 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