Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-08 @ 11:54 AM
Study NCT ID:
NCT03386760
Status:
COMPLETED
Last Update Posted:
2024-07-22
First Post:
2017-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-19', 'studyFirstSubmitDate': '2017-12-18', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of decrease of tattoos 2 months after the third session as compared to baseline on standardized pictures', 'timeFrame': '2 month after the end of laser utilisation'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Pain with EVA test', 'timeFrame': '2 months after one session of laser utilisation'}, {'measure': 'Evaluation of tolerance', 'timeFrame': '2 months after one session of laser utilisation', 'description': 'correlation between EVA test and dermatological clinical signs'}, {'measure': 'satisfaction evaluation of depigmanetation tattoo', 'timeFrame': '2 months after one session of laser utilisation', 'description': 'satisfaction tests'}, {'measure': 'Skin biopsies', 'timeFrame': 'immediately after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tattoo'], 'conditions': ['Tattoo; Pigmentation']}, 'descriptionModule': {'briefSummary': 'The investigators developed an ultra-speed picosecond laser (20ps) with a 20gHz repetition rate that provide very promising results in vitro and in ex vivo skin to remove skin tattoos.\n\nThe aim of this study is to evaluate the efficacy and tolerance of a new ultra-speed picosecond laser and to compare it to a nanosecond laser for treating black tattoos.\n\nIn a first phase of the study 10 patients with black tattoos will be treated with increasing fluencies of the picosecond laser to the optimal parameters in terms of efficacy and tolerance.\n\nIn a second phase, 10 additional subjects with black tattoos will be treated after central randomization on half of the tattoo with the picosecond laser (with the parameters determined in the first phase) and the other half treated with a nanosecond laser.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Black tattoos with surface between 10 and 100 cm²\n* Skin type I to VI\n\nExclusion Criteria:\n\n* Childbearing age women\n* Active dermatosis located on the tattoo\n* Personal history of hypertrophic scars or keloids\n* Pigmentary or vascular lesions located on the tattoo\n* Subject taking oral steroid or retinoid or have any risk of delayed healing problems\n* Acquired or hereditary conditions that could leead to a delayed healing\n* Allergy to xylocaine, prilocaine or lidocaine'}, 'identificationModule': {'nctId': 'NCT03386760', 'acronym': 'PicoS', 'briefTitle': 'Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos', 'orgStudyIdInfo': {'id': '17-PP-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A- Ultra-Speed Picosecond laser', 'description': 'Utilisation of Ultra-speed Picosecond laser for tattoo depigmentation', 'interventionNames': ['Device: Laser Utilisation PicoSecond']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B- Nanosecond laser', 'description': 'Utilisation of Nanosecond laser for tattoo depigmentation', 'interventionNames': ['Device: Laser Utilisation Nano-second']}], 'interventions': [{'name': 'Laser Utilisation PicoSecond', 'type': 'DEVICE', 'description': 'Laser utilisation for tattoo depigmentation\n\n1 session every month for a total of 3 sessions', 'armGroupLabels': ['A- Ultra-Speed Picosecond laser']}, {'name': 'Laser Utilisation Nano-second', 'type': 'DEVICE', 'description': 'Laser utilisation for tattoo depigmentation\n\n1 session every month for a total of 3 sessions', 'armGroupLabels': ['B- Nanosecond laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice - Dermatologie - Hôpital Archet', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}