Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 8:26 PM
Study NCT ID:
NCT01735734
Status:
UNKNOWN
Last Update Posted:
2012-11-28
First Post:
2012-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Effects of Air-cooling on Capillary Malformations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562760', 'term': 'Capillary Malformations, Congenital, 1'}, {'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-25', 'studyFirstSubmitDate': '2012-11-24', 'studyFirstSubmitQcDate': '2012-11-25', 'lastUpdatePostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation', 'timeFrame': '10 minutes', 'description': "In a temperature controlled room, the participant's capillary diameter/depth and skin/core temperatures will be taken from their CM prior to cooling the skin. The patients' CM will be cooled for a duration of 1 minute. The above measurements will be repeated immediately after 1 minute of cooling."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Skin disease', 'Capillary Malformation', 'Laser therapy'], 'conditions': ['Capillary Malformation', 'Laser', 'Skin Cooling']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to ascertain the effects of cutaneous air cooling on vessel diameter within Capillary Malformations (CM).', 'detailedDescription': "Capillary malformation (CM) is the most common vascular malformation occurring in approximately 0.3% of all newborn. The standard treatment for facial or aesthetically sensitive CM's is flashlamp Pulsed Dye Laser. Skin cooling prior to laser treatment of CMs is standard practice within our department. The effects of skin cooling on the vasculature within CMs are poorly understood. Previous studies by our department have shown that raising ambient temperature increases CM vessel size. It has been postulated that by increasing CM vessel size, it may also increase the effectiveness of treatment. We hypothesize that cooling the skin during laser treatment may cause vasconstriction of the superficial vessels within the CM. This may have an impact on treatment success."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Capillary Malformation identified through our department database', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult more than 16 years of age\n* Patient diagnosed with Capillary Malformation\n\nExclusion Criteria:\n\n* Patients less than 16 years of age'}, 'identificationModule': {'nctId': 'NCT01735734', 'briefTitle': 'Assessing the Effects of Air-cooling on Capillary Malformations', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Health Service, United Kingdom'}, 'officialTitle': 'An Observational Study as to the Effects of Cutaneous Air-cooling on Blood Vessel Diameter in Capillary Malformations', 'orgStudyIdInfo': {'id': 'GN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Capillary malformation', 'interventionNames': ['Device: Air cooling to CM site']}], 'interventions': [{'name': 'Air cooling to CM site', 'type': 'DEVICE', 'armGroupLabels': ['Capillary malformation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G4 0SF', 'city': 'Glasgow', 'country': 'United Kingdom', 'contacts': [{'name': 'Irving Ling, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'centralContacts': [{'name': 'Irving Ling, MBBS', 'role': 'CONTACT', 'email': 'irvingling@nhs.net'}], 'overallOfficials': [{'name': 'Irving Ling, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Greater Glasgow and Clyde'}, {'name': 'Adam Gilmour, MBChB, MRCS (Ed)', 'role': 'STUDY_CHAIR', 'affiliation': 'NHS Greater Glasgow and Clyde'}, {'name': 'Iain Mackay, MBChb, MRCS, FRCS (plast)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NHS Greater Glasgow and Clyde'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Health Service, United Kingdom', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academic Foundation Doctor, Honorary Clinical Fellow', 'investigatorFullName': 'Dr Irving Ling', 'investigatorAffiliation': 'NHS Greater Glasgow and Clyde'}}}}