Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-03-24 @ 12:10 PM
Study NCT ID:
NCT03068156
Status:
UNKNOWN
Last Update Posted:
2017-03-01
First Post:
2017-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562642', 'term': 'Amyloidosis, Primary Cutaneous'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054018', 'term': 'Lasers, Excimer'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-26', 'studyFirstSubmitDate': '2017-02-20', 'studyFirstSubmitQcDate': '2017-02-26', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Roughness evaluation by using Visioscan® VC98', 'timeFrame': 'Change from baseline roughness at every 2 weeks up to 16 weeks', 'description': 'The improvement of roughness evaluation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['308-nm excimer laser', 'primary localized cutaneous amyloidosis', 'lichen amyloidosis', 'Asians'], 'conditions': ['Lichen Amyloidosis']}, 'descriptionModule': {'briefSummary': 'Efficacy of 308-nm excimer laser for primary localized cutaneous amyloidosis treatment in Asians, pilot study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, aged \\>18 years old with lichen amyloidosis diagnosed by using clinical presentation and pathologic features\n\nExclusion Criteria:\n\n* Those with cutaneous amyloidosis associated systemic diseases\n* Pregnancy or lactating woman\n* Those who are allergic to urea, olive oil\n* Those who are photosensitive to ultraviolet radiation\n* Those who had been previously treated with medications/ radiation/ laser within 3 months for systemic and 1 month for topical therapy'}, 'identificationModule': {'nctId': 'NCT03068156', 'briefTitle': 'Efficacy of 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Efficacy of 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians: Pilot Study', 'orgStudyIdInfo': {'id': 'CU_308excimer_amyloidosis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'excimer laser', 'interventionNames': ['Radiation: 308-nm excimer laser']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': '308-nm excimer laser', 'type': 'RADIATION', 'description': 'monochromator UVB laser (308nm)', 'armGroupLabels': ['excimer laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Anukorn Sriaram, B.Eng.', 'role': 'CONTACT', 'email': 'photochulateam@gmail.com', 'phone': '66860645757'}, {'name': 'Jaruwan Pemcharoen, B.Sc.', 'role': 'CONTACT', 'email': 'photochulateam@gmail.com', 'phone': '66823573912'}, {'name': 'Pawinee Rerknimitr, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chanat Kumtornrat, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kitipong Wantavornprasert, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Einapak Amnarttrakul, M.D.', 'role': 'CONTACT', 'email': 'einapak.b@chula.ac.th', 'phone': '7521182743'}, {'name': 'Pravit Asawanonda, M.D., PhD', 'role': 'CONTACT', 'email': 'pravit.a@chula.ac.th, fibrosis@gmail.com', 'phone': '66818129393'}], 'overallOfficials': [{'name': 'Einapak Amnarttrakul, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ratchadapiseksompotch Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}