Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 3:31 AM
Study NCT ID:
NCT04456257
Status:
UNKNOWN
Last Update Posted:
2020-07-02
First Post:
2020-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057896', 'term': 'Striae Distensae'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in striae roughness by Antera 3D image', 'timeFrame': 'change from baseline in striae roughness score at 6 months'}, {'measure': 'Change in average Melanin index by Antera 3D image', 'timeFrame': 'change from baseline in average melanin index at 6 months'}, {'measure': 'Change in melanin variation index by Antera 3D image', 'timeFrame': 'change from baseline in melanin variation index at 6 months'}], 'secondaryOutcomes': [{'measure': 'Investigator assessment scores', 'timeFrame': 'Baseline, 1, 3 and 6 months after final treatment', 'description': 'Clinical improvement was evaluated by comparing pre and post photographs by 2 independent investigators.'}, {'measure': 'Patient satisfaction scores', 'timeFrame': 'Baseline, 1, 3, and 6 months after final treatment', 'description': 'patient satisfaction questionnaire was done by grading on a scale of 0 to 4; 0: no improvement, 1: \\<25% improvement, 2: 25-50% improvement, 3: 51-75% improvement, 4: \\> 75% improvement'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['striae alba, fractional picosecond laser, stretch marks'], 'conditions': ['Striae Alba']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy and safety of a fractional 1,064 nm picosecond laser for the treatment of striae alba.', 'detailedDescription': 'Striae distensae are atrophic dermal scars that can cause psychosocial distress on affected patients. Despite numerous available therapeutic modalities, no gold standard therapy has been established. Picosecond lasers are a newer advancement in lasers that have primarily used in the treatment of tattoos. A fractional 1064-nm picosecond laser has recently become available for the treatment of pigmentation and skin rejuvenation. The main mechanism of action is tissue ablation via laser induced optical breakdown (LIOB) which occur when pulse intensity is high enough to strip electrons and generating plasma, the plasma absorbs the remaining laser energy forming a cavitation bubble within the dermis which has been demonstrated to improve fine wrinkles and acne scar through the stimulation of collagen formation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Striae alba on abdomen for more than 3 months\n* Fitzpatrick skin type III-V\n\nExclusion Criteria:\n\n* Pregnancy and breastfeeding\n* Previous topical treatment, filler injection, chemical peel or laser treatment within 6 months before starting the study\n* History of using Isotretinoin\n* Photosensitive dermatoses, Infection, eczema\n* Past history or family history of malignancy\n* History of herpes infection\n* History of hypertrophic scar or keloid, connective tissue disease\n* History of collagen or elastin disease\n* History of smoking\n* Significant fluctuations in weight in the past 6 months'}, 'identificationModule': {'nctId': 'NCT04456257', 'briefTitle': 'The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae', 'orgStudyIdInfo': {'id': 'Si 591/2561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fractional Picosecond 1,064 nm laser', 'description': 'The subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser', 'interventionNames': ['Device: fractional picosecond 1,064 nm laser']}], 'interventions': [{'name': 'fractional picosecond 1,064 nm laser', 'type': 'DEVICE', 'description': 'The parameter of laser was 8-mm spot size, 0.6 mJ/cm2, 750 ps, 10 Hz, 2 passes. The treatment was done in every 4 weeks for 4 sessions.', 'armGroupLabels': ['Fractional Picosecond 1,064 nm laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok Noi', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Woraphong Manuskiatti, M.D.', 'role': 'CONTACT', 'email': 'doctorlaser@gmail.com', 'phone': '+6624199922'}, {'name': 'Arisa Kaewkes, M.D.', 'role': 'CONTACT', 'email': 'searisa@yahoo.com', 'phone': '+66895710956'}], 'facility': 'Faculty of Medicine, Siriraj hospital, Mahidol University', 'geoPoint': {'lat': 13.76266, 'lon': 100.47798}}], 'centralContacts': [{'name': 'Woraphong Manuskiatti, M.D.', 'role': 'CONTACT', 'email': 'doctorlaser@gmail.com', 'phone': '+66819150555'}, {'name': 'Arisa Kaewkes, M.D.', 'role': 'CONTACT', 'email': 'searisa@yahoo.com', 'phone': '+66895710956'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Woraphong Manuskiatti, M.D.', 'investigatorAffiliation': 'Mahidol University'}}}}