Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-03-26 @ 11:46 AM
Study NCT ID:
NCT00689650
Status:
UNKNOWN
Last Update Posted:
2008-06-03
First Post:
2008-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'lastUpdateSubmitDate': '2008-05-30', 'studyFirstSubmitDate': '2008-05-30', 'studyFirstSubmitQcDate': '2008-05-30', 'lastUpdatePostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of skin texture from baseline'}]}, 'conditionsModule': {'conditions': ['Burn Scar Patients']}, 'descriptionModule': {'briefSummary': 'The objective was to evaluate the efficacy of 1540 nm fractional laser treatment of mature burn scars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Burn scars with and without previous skin grafting.\n\nExclusion Criteria:\n\n* A tendency to produce hypertrophic scars or keloids,\n* Previous treatment with dermabrasio, chemical peel, filler, laser treatment or Intense Pulsed Light (IPL) of study areas,\n* Photosensitivity,\n* Pregnancy or lactation,\n* Current anticoagulative medication,\n* Oral retinoid drugs within the past 6 months,\n* Pigmentation after recent exposure to sun or solarium,\n* Patients not considered to be able to follow the treatment protocol.'}, 'identificationModule': {'nctId': 'NCT00689650', 'briefTitle': 'Fractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Fractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'H-D-2007-0094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Device: 1540 nm fractional laser']}, {'type': 'NO_INTERVENTION', 'label': 'B'}], 'interventions': [{'name': '1540 nm fractional laser', 'type': 'DEVICE', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen NV', 'country': 'Denmark', 'facility': 'Bispebjerg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}}}}