Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT05365360
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2022-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sham LaserCap vs. LaserCap SD vs. LaserCap HD+
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2022-05-04', 'studyFirstSubmitQcDate': '2022-05-04', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target area total hair count at 26 weeks via phototrichogram', 'timeFrame': '26 weeks'}], 'secondaryOutcomes': [{'measure': 'Target area vellus hair count at 26 weeks via phototrichogram', 'timeFrame': '26 weeks'}, {'measure': 'Target area terminal hair count at 26 weeks via phototrichogram', 'timeFrame': '26 weeks'}, {'measure': 'Physician assessed improvement via global photography at 26 weeks', 'timeFrame': '26 weeks'}, {'measure': 'Hair growth rate at 26 weeks via phototrichogram', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'Androgenetic alopecia (AGA) is a prevalent disease, occurring in 80% of Caucasian men and 50% of Caucasian women by age 701. Treatments for AGA are limited, and presently the only FDA-approved medications for AGA are topical minoxidil and oral finasteride1.\n\nIn addition to medical therapies, FDA-cleared medical devices are now utilized for the treatment of AGA as of 20072. These devices, termed low level laser therapy (LLLT), come in multiple forms including combs, helmets and sports cap wearable devices2. These home-use, wearable devices utilize the \\~650 nm wavelength laser light to stimulate the hair follicle mitochondria and thereby promote hair growth, a process termed "photobiomodulation"3.\n\nRecent meta-analyses investigating photobiomodulation and LLLT for AGA have noted an increase in fluence or energy delivered per cm is associated with increased hair density3. However, randomized control trials (RCT) with direct comparison of LLLT devices of different fluences has yet to be performed. Accordingly, in the present study we aim to investigate if increasing fluence in LLLT devices is associated with increased hair density by comparing sham LaserCap to LaserCap SD (1.15 J/cm2, low fluence) and LaserCap HD+ (3.93 J/cm2, high fluence) in RCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 25 years and older\n* Men and women with AGA, untreated or with 6-month washout of previous treatments\n* Men: Norwood stage IIa - V\n* Women: Ludwig I-1 - II-2, or frontal pattern\n* All patients: Fitzpatrick skin types I to IV\n\nExclusion criteria:\n\n* Men: Norwood stage Va, VI, VII\n* Women: Ludwig stage III, advanced\n* All patients: Fitzpatrick skin types V, VI\n* Current use or within the past six month of other treatment for AGA, including topical and oral minoxidil, topical and oral finasteride and dutasteride\n* Age 0-25 years'}, 'identificationModule': {'nctId': 'NCT05365360', 'briefTitle': 'Sham LaserCap vs. LaserCap SD vs. LaserCap HD+', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Effect of Increasing Fluence on Efficacy of Low Level Laser Therapy for Androgenetic Alopecia, a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'LLLT Fluence RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham LaserCap', 'description': 'Sham device', 'interventionNames': ['Device: Sham LaserCap']}, {'type': 'EXPERIMENTAL', 'label': 'Lasercap SD', 'description': 'Low fluence LLLT', 'interventionNames': ['Device: LaserCap SD']}, {'type': 'EXPERIMENTAL', 'label': 'Lasercap HD+', 'description': 'High fluence LLLT', 'interventionNames': ['Device: LaserCap HD+']}], 'interventions': [{'name': 'LaserCap SD', 'type': 'DEVICE', 'description': 'LaserCap SD', 'armGroupLabels': ['Lasercap SD']}, {'name': 'Sham LaserCap', 'type': 'DEVICE', 'description': 'Sham LaserCap', 'armGroupLabels': ['Sham LaserCap']}, {'name': 'LaserCap HD+', 'type': 'DEVICE', 'description': 'LaserCap HD+', 'armGroupLabels': ['Lasercap HD+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patrick M Jedlowski, MD', 'role': 'CONTACT', 'phone': '520-621-7168'}, {'name': 'Patrick M Jedlowski, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Banner University Dermatology', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'centralContacts': [{'name': 'Patrick Jedlowski, MD', 'role': 'CONTACT', 'email': 'pjedlowski@email.arizona.edi', 'phone': '(520) 694-8888'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Transdermal Cap, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}