Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-25 @ 12:28 PM
Study NCT ID:
NCT04178161
Status:
UNKNOWN
Last Update Posted:
2019-11-26
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-12-12', 'releaseDate': '2023-11-21'}], 'estimatedResultsFirstSubmitDate': '2023-11-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006945', 'term': 'Hyperhidrosis'}], 'ancestors': [{'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study involves a single group of patients with Hyperhidrosis. Left and right palms are randomized for treatment versus control (untreated).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of changes in sweat production using gravimetric method', 'timeFrame': 'Measured at multiple time points, last at 6 months', 'description': 'Compare treated side to control side'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hyperhidrosis']}, 'descriptionModule': {'briefSummary': 'Hyperhidrosis is a condition in which sweating is in excess of that required for normal regulation of body temperature. Commonly affected areas in primary hyperhidrosis include axillae, palms and soles. Secondary hyperhidrosis can affect scalp, face, neck, back, groin and legs. Hyperhidrosis can negatively impact, employment, relationships, or other aspects of quality of life.\n\nThe investigators propose to investigate the use of a unique image-guided laser to specifically ablate eccrine sweat glands.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects of ages between 18 and 65 years.\n2. Subjects with any Fitzpatrick skin type.\n3. Subjects who are proficient in the English language.\n4. Willingness to participate in the study.\n5. Willingness to undergo experimental procedure.\n6. Informed consent agreement signed by the subject.\n7. Willingness to follow the follow-up schedule.\n8. Willingness not to use any other hyperhidrosis treatment to the tests sites during the study period (i.e. deodorant, at-home iontophoresis, Botox, MiraDry).\n9. Patient rates symptoms at level "3" or "4" on the hyperhidrosis disease severity scale (HDSS, see below).\n10. Subject in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.\n11. No known allergy to iodine or potato starch\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Subjects on systemic treatment for hyperhidrosis, such as anticholinergic drugs (e.g. glycopyrrolate), sedatives or tranquilizers, within the past 8 weeks.\n3. Subjects who have undergone surgical excision of sweat glands or sympathectomy for hyperhidrosis.\n4. Subjects with an underlying disorder, such as neurologic injury or disease affecting the autonomic system, vascular disorders and metabolic disorders (e.g. hyperthyroidism, diabetes mellitus) that can produce hyperhidrosis\n5. Subjects with a history of coronary artery disease.\n6. Subjects with a history of poor compliance or psychosis\n7. Subjects taking SSRIs, SNRIs, TCAs, or MAOIs\n8. Subjects with known hypersensitivity to methylene blue\n9. Subjects with cardiac pacemaker or any other electrically powered implantable device.\n10. Subjects not proficient in the English language.\n11. Subject not in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.\n12. Known allergy to iodine or potato starch.'}, 'identificationModule': {'nctId': 'NCT04178161', 'briefTitle': 'Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis', 'orgStudyIdInfo': {'id': '2016P001071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated side', 'description': 'Two regions are designated on the upper back. Randomized to treatment and control sides.\n\nTreatment side receives laser treatment of the sweat glands.', 'interventionNames': ['Device: Laser treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Untreated side', 'description': 'Two regions are designated on the upper back. Randomized to treatment and control sides.\n\nControl side is untreated.'}], 'interventions': [{'name': 'Laser treatment', 'type': 'DEVICE', 'description': 'Iontophoresis of methylene blue is used to identify the sweat glands. An image guided fractional erbium laser is used to specifically target these glands for ablation.', 'armGroupLabels': ['Treated side']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kimberli Bell', 'role': 'CONTACT', 'email': 'kbell2@partners.org', 'phone': '617-724-4937'}, {'name': 'Fernanda H Sakamoto, MD, PhD, MD, PhD', 'role': 'CONTACT', 'email': 'fsakamoto@partners.org'}, {'name': 'R. Rox Anderson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fernanda H Sakamoto, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital - Wellman Center for Photomedicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Yakir Levin, MD, PhD', 'role': 'CONTACT', 'email': 'ylevin2@partners.org', 'phone': '617-726-3827'}], 'overallOfficials': [{'name': 'R Rox Anderson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sciton', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Richard Rox Anderson, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-11-21', 'type': 'RELEASE'}, {'date': '2023-12-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Richard Rox Anderson, MD, Professor, Massachusetts General Hospital'}}}}