Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT01461694
Status:
UNKNOWN
Last Update Posted:
2012-05-14
First Post:
2011-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facial Hair Reduction Using Intense Pulsed Light (IPL) & Alexandrite Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006628', 'term': 'Hirsutism'}], 'ancestors': [{'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014770', 'term': 'Virilism'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062325', 'term': 'Intense Pulsed Light Therapy'}, {'id': 'D053844', 'term': 'Lasers, Solid-State'}], 'ancestors': [{'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-11', 'studyFirstSubmitDate': '2011-10-25', 'studyFirstSubmitQcDate': '2011-10-26', 'lastUpdatePostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total Hair Count measurement at 1month post final treatment from baseline', 'timeFrame': 'Baseline and 1 month', 'description': 'Pre Treatment hair count assessed using videomicroscopy as baseline. Post final treatment hair counts will be measured again at 1month to assess if there has been a reduction in total hair count from pre-treatment'}, {'measure': 'Change in total hair count at 3months post final treatment from baseline', 'timeFrame': 'Baseline and 3months post final treatment', 'description': 'Pre Treatment hair count assessed using videomicroscopy as baseline. Post final treatment hair counts will be measured again at 3months to assess if there has been a reduction in total hair count from pre-treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hirsutism', 'Laser', 'Hair Reduction', 'IPL', 'Intense Pulsed Light'], 'conditions': ['Hirsutism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of the IPL system 650advance handpiece with the alexandrite laser for the purposes of female facial hair reduction', 'detailedDescription': 'This is a randomised (splitface)controlled trial, comparing the use of the Intense Pulsed Light (IPL) system 650 advance handpiece against the Alexandrite Laser for the purposes of female facial hair reduction. Previous studies have shown that the alexandrite laser is superior to IPL in achieving hair reduction. A new handpiece (Lynton, Lumina 650 advance) available for the IPL system is designed to further optimise its use in removing female facial hair (particularly those hair colours previously unresponsive to treatment). This study will compare the alexandrite laser to the IPL system using the new handpiece. This may lead to improvements in the treatment of female patients with male pattern facial hair. Female patients referred to our facial hair reduction service will be recruited to this study. 1/2 their face will be treated with IPL and 1/2 with alexandrite laser. Each participant will receive 6 full treatments at approximately 6 weekly intervals. Participants will be asked to fill in a satisfaction questionnaire and have clinical photographs taken pre treatment and at 1 and 3months post final treatment. All treatments will be carried out in our dedicated laser suite at Glasgow Royal Infirmary.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female Patients\n* Minimum age 16years old\n* Fitzpatrick skin types I-III\n* Significant facial hair.\n\nExclusion Criteria:\n\n* Fitzpatrick skin types IV-VI\n* Age less than 16years old\n* Males\n* No visible facial hair growth\n* Use of electrolysis or depilatory creams 6weeks prior to treatment\n* Active acnes\n* Current coldsore\n* Previous facial hair removal with laser or IPL in past 12 months\n* Sun tanned skin'}, 'identificationModule': {'nctId': 'NCT01461694', 'briefTitle': 'Facial Hair Reduction Using Intense Pulsed Light (IPL) & Alexandrite Laser', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'Comparison of Intense Pulsed Light System 650 Advance Hand-Piece and Alexandrite Laser for Female Facial Hair Reduction', 'orgStudyIdInfo': {'id': 'GN11SU380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IPL', 'description': 'Half face treated with IPL', 'interventionNames': ['Device: Intense Pulsed Light (IPL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alexandrite Laser', 'description': 'Half face treated with Alexandrite Laser', 'interventionNames': ['Device: Alexandrite Laser']}], 'interventions': [{'name': 'Intense Pulsed Light (IPL)', 'type': 'DEVICE', 'description': 'Half Face Treated with IPL', 'armGroupLabels': ['IPL']}, {'name': 'Alexandrite Laser', 'type': 'DEVICE', 'description': 'Half face treated with Alexandrite Laser', 'armGroupLabels': ['Alexandrite Laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G4 0SF', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Adam Gilmour, MBChB, MRCS (Ed)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Greater Glasgow & Clyde'}, {'name': 'Iain Mackay, MBChb, MRCS, FRCS (plast)', 'role': 'STUDY_CHAIR', 'affiliation': 'NHS Greater Glasgow & Clyde'}, {'name': 'Vivek Sivarajan, MBChB, MRCS, MD, FRCS (Plas)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NHS Greater Glasgow & Clyde'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Laser Research Fellow', 'investigatorFullName': 'Adam Gilmour', 'investigatorAffiliation': 'NHS Greater Glasgow and Clyde'}}}}