Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-13 @ 11:33 PM
Study NCT ID:
NCT00365118
Status:
COMPLETED
Last Update Posted:
2008-06-03
First Post:
2006-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Naevus Flammeus Using Intense Pulsed Light and Pulsed Dye Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019339', 'term': 'Port-Wine Stain'}, {'id': 'D018324', 'term': 'Hemangioma, Capillary'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006391', 'term': 'Hemangioma'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054025', 'term': 'Lasers, Dye'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-02', 'studyFirstSubmitDate': '2006-08-15', 'studyFirstSubmitQcDate': '2006-08-16', 'lastUpdatePostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Port wine stains', 'naevus flammeus'], 'conditions': ['Port-Wine Stain']}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to compare efficacy and adverse effects of pulsed dye laser and intense pulsed light in patients with port wine stains.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with previously untreated and previously laser-treated naevus flammeus. Naevus flammeus measuring at least 5 x 7 cm within a single anatomical area. For example, the face corresponding to dermatomes V1, V2 and V3, back, abdomen, arms and legs.Patients aged two or above.Patients with skin types I-III.\n\nExclusion Criteria:\n\n* Patients below two years of age.\n* Pregnant or breastfeeding patients.\n* Patients with known increased sensitivity to visible light.\n* Patients with a tendency to produce hypertrophic scars or celoids.\n* Patients with skin types IV, V and VI.\n* Patients who are clearly pigmented following recent exposure to the sun or a solarium.\n* Patients treated with Roaccutane during the last six months.\n* Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients, etc.).'}, 'identificationModule': {'nctId': 'NCT00365118', 'briefTitle': 'Treatment of Naevus Flammeus Using Intense Pulsed Light and Pulsed Dye Laser', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'orgStudyIdInfo': {'id': 'KF-01-278867'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pulsed dye laser (Candela), Intense pulsed light (Palomar)', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'state': 'Copenhagen Nv', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Merete Hædersdal, MD, PhD, DrMedSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}}}}