Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-09 @ 4:51 PM
Study NCT ID:
NCT01754233
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2012-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053844', 'term': 'Lasers, Solid-State'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-23', 'studyFirstSubmitDate': '2012-12-18', 'studyFirstSubmitQcDate': '2012-12-18', 'lastUpdatePostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Photographic Evaluation', 'timeFrame': 'up to 4 months post last treatment'}], 'secondaryOutcomes': [{'measure': 'Reporting of Adverse Events', 'timeFrame': 'up to 4 months post last treatment'}, {'measure': 'Satisfaction Questionnaire', 'timeFrame': 'up to 4 months post treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dermal and Epidermal Pigmented Lesions']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess treatment for facial dermal and epidermal pigmented lesions using the 755nm Alexandrite laser.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Is a healthy male or female between 18 and 85 years old\n2. Has unwanted dermal and/or epidermal pigmented lesions or desires skin toning and wishes to undergo laser treatments.\n3. Is willing to consent to participate in the study.\n4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.\n5. Has Fitzpatrick skin types III to IV.\n\nExclusion Criteria:\n\n1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.\n2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.\n3. The subject has active or localized systemic infections\n4. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.\n5. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.\n6. The subject has used Accutane within 6 months prior to enrollment.\n7. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.\n8. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).\n9. The subjects had prior treatment with laser or other devices in the treatment area within 3 months.\n10. The subject has a history of keloids or hypertrophic scarring.\n11. The subject has evidence of compromised wound healing.\n12. The subject has a history of squamous cell carcinoma or melanoma\n13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.\n14. Is allergic to topical lidocaine or topical steroids."}, 'identificationModule': {'nctId': 'NCT01754233', 'briefTitle': 'Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cynosure, Inc.'}, 'orgStudyIdInfo': {'id': 'CYN12-PICO-PL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '755nm Alexandrite Laser', 'description': '755nm Alexandrite Laser', 'interventionNames': ['Device: 755nm Alexandrite Laser']}], 'interventions': [{'name': '755nm Alexandrite Laser', 'type': 'DEVICE', 'description': '755nm Alexandrite Laser for epidermal and dermal pigmented lesions', 'armGroupLabels': ['755nm Alexandrite Laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Skin Care Physicians', 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}], 'overallOfficials': [{'name': 'Patricia Krantz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cynosure, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cynosure, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}