Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-03-06 @ 11:52 AM
Study NCT ID:
NCT01801202
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2013-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of LightSheer Duet 805nm HS Handpiece
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-03-14', 'releaseDate': '2017-01-25'}], 'estimatedResultsFirstSubmitDate': '2017-01-25'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-28', 'studyFirstSubmitDate': '2013-02-21', 'studyFirstSubmitQcDate': '2013-02-26', 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with Adverse Events', 'timeFrame': '1 year', 'description': 'To evaluate the safety of hair removal using the LightSheer Duet HS 805 nm handpiece'}, {'measure': 'Hair count', 'timeFrame': '6 monts follow up', 'description': 'To verify hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm handpiece'}], 'secondaryOutcomes': [{'measure': "Subject's comfort using VAS", 'timeFrame': 'Baseline, 4, 8, 12, 16 weeks;', 'description': "To evaluate subject's assessment of comfort associated with treatments"}, {'measure': "Asses subject's perception of improvement and satisfaction", 'timeFrame': '8, 16 weeks following baseline; 3 and 6 monts follow up', 'description': "To evaluate subject's satisfaction with hair removal treatments and assessment of improvement using subject's questionnaire"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hair Removal']}, 'descriptionModule': {'briefSummary': '* The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction.\n* Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.\n* Each subject will receive five treatments at four to six week intervals and return for follow-up visits at three and six months after the last treatment for evaluation of the treated areas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to read, understand and provide written Informed Consent;\n2. Healthy adult, male or female, 18 years of age or older with skin type I-IV;\n3. Having a suitable treatment area for hair removal;\n4. Able and willing to comply with the treatment/follow-up schedule and requirements;\n5. Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.\n\nExclusion Criteria:\n\n1. Pregnant, expectation of pregnancy, postpartum or nursing (\\<6 months);\n2. Hormonal disorders that may affect hair growth;\n3. Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;\n4. Livedo reticularis;\n5. Uncontrolled systemic diseases such as diabetes;\n6. Active infections in the treated area;\n7. Dysplastic nevi;\n8. Significant concurrent skin conditions or any inflammatory skin conditions;\n9. Active cold sores, open lacerations or abrasions;\n10. Chronic or cutaneous viral, fungal, or bacterial diseases;\n11. Current cancer;\n12. History of skin cancer or pre-cancerous lesions at the treatment areas;\n13. Use of Accutane™ (Isotretinoin) within the past six month;\n14. Keloid formation in the treatment area;\n15. Tattoos in the treatment area;\n16. Bleeding coagulopathies or use of anticoagulants;\n17. Auto-immune disorders;\n18. Erythema ab igne, when identified treatments should be discontinued;\n19. Photosensitivity disorder that can be exacerbated by laser or intense light;\n20. Herpes simplex in the treatment area;\n21. Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;\n22. Poor wound healing;\n23. Sunburns;\n24. Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a week) and during the course of the evaluation;\n25. Prior skin treatment with laser or other devices on the same treated areas within the last six months prior to study enrollment or during the course of the study.'}, 'identificationModule': {'nctId': 'NCT01801202', 'briefTitle': 'Clinical Evaluation of LightSheer Duet 805nm HS Handpiece', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumenis Be Ltd.'}, 'officialTitle': 'Clinical Evaluation of LightSheer Duet 805nm HS Handpiece', 'orgStudyIdInfo': {'id': 'LUM-ABU-HS 805nm-12-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hair removal', 'description': 'hair removal treatment using 805nm LightSheer Duet HS handpiece', 'interventionNames': ['Device: LightSheer Duet HS handpiece']}], 'interventions': [{'name': 'LightSheer Duet HS handpiece', 'type': 'DEVICE', 'description': 'The approach to be studied here relies on a cleared modality, the LightSheer Duet High Speed (HS) that uses 805 nm diode laser with vacuum (K053628).', 'armGroupLabels': ['Hair removal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Laser & Skin Surgery Medical Group Inc', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Suzanne Kilmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laser & Skin Surgery Medical Group, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lumenis Be Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-01-25', 'type': 'RELEASE'}, {'date': '2017-03-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Lumenis Be Ltd.'}}}}