Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT04599751
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2020-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Trio Laser Module for Hair Removal Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-12-01', 'mcpReleaseN': 5, 'releaseDate': '2022-11-02'}, {'resetDate': '2022-12-29', 'mcpReleaseN': 6, 'releaseDate': '2022-12-06'}, {'resetDate': '2023-01-31', 'mcpReleaseN': 7, 'releaseDate': '2023-01-08'}, {'resetDate': '2023-02-27', 'mcpReleaseN': 8, 'releaseDate': '2023-02-05'}, {'resetDate': '2023-03-27', 'mcpReleaseN': 9, 'releaseDate': '2023-02-28'}, {'resetDate': '2023-08-11', 'mcpReleaseN': 10, 'releaseDate': '2023-07-23'}], 'estimatedResultsFirstSubmitDate': '2022-11-02'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2020-10-11', 'studyFirstSubmitQcDate': '2020-10-18', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hair count', 'timeFrame': '3 month after the last treatment', 'description': 'Change in hair count, preformed by blinded evaluators, based on photographs taken at 3m FU visit compared to baseline'}, {'measure': 'Safety- Adverse events', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Adverse events and serious AE reported at any time during the trial or follow-up'}], 'secondaryOutcomes': [{'measure': 'Investigator\'s assessment of the tolerability to the treatment using a 5-point Likert scale (when "0" indicates "none" and "4" indicates "sever").', 'timeFrame': 'up to 24 weeks', 'description': 'The investigator will assess the treatment area and score treatment related side effects using a 5-point likert scale, before and after the treatment'}, {'measure': 'Subject\'s tolerability to the treatment, using a 5-point Likert scale (when "0" indicates "none" and "4" indicates "sever").', 'timeFrame': 'up to 24 weeks', 'description': 'Subjects will be requested to scale any sensation of stinging, tingling, itching and, burning using the 5-point Likert scale, before and after the treatment'}, {'measure': 'Subject treatment related pain assessment, using VAS ( when "0" indicates "no pain" and "10" " worst possible pain"', 'timeFrame': 'up to 24 weeks', 'description': 'Subjects will be requested to scale their treatment related pain'}, {'measure': 'Subject\'s satisfaction from the treatment, using a 5-point Likert scale (when "1" indicates very dissatisfied and "5" very satisfied)', 'timeFrame': '3 months after the last treatment', 'description': 'Subjects will be requested to scale their satisfaction from the treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hair Removal Treatment']}, 'descriptionModule': {'briefSummary': 'The study is aimed to assess the safety and efficacy of hair removal treatments, using the Trio Laser Module (Alma Lasers).\n\nThe study will include 36 subjects that will undergo axilla and bikini line hair removal treatments. Safety and efficacy will be evaluated 3- months after the last treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing to undergo hair removal treatments at the Axilla and the Bikini line.\n* Between 18 and 70 years of age.\n* Reasonably good health, as defined by the Investigator.\n* Agrees to avoid tanning during their participation in this study.\n* Agrees to shave the treatment area prior to the treatment visit, according to the investigator's instructions.\n* Subjects with dark brown hair.\n* Eligible for treatment following a test spot without negative effects.\n* Provided written Informed Consent and photo consent.\n\nExclusion Criteria:\n\n* History of laser hair removal in the treatment area.\n* Pregnant, lactating or planning to get pregnant within the study period.\n* Unwilling to use a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, if of childbearing age.\n* History of photosensitivity or use of medication with photosensitizing properties.\n* Active infection in the treatment area.\n* History or evidence of any chronic or reoccurring skin disease or disorder affecting the treatment area.\n* History of keloid scarring or hypertrophic scar formation.\n* Tattoo in the treatment area.\n* Subject has been tanning within the past 30 days.\n* History of confounding cancerous or pre-cancerous skin lesions in the treatment area.\n* History of connective, metabolic or atrophic skin disease.\n* Subject has used prohibited therapies, oral prescription medication, or topical meds (steroids) on the treatment area within 30 days prior to enrollment.\n* History of autoimmune disorder"}, 'identificationModule': {'nctId': 'NCT04599751', 'briefTitle': 'The Trio Laser Module for Hair Removal Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alma Lasers'}, 'officialTitle': 'The Safety and Efficacy of Trio Diode Laser Module for Hair Removal Treatment in All Skin Types', 'orgStudyIdInfo': {'id': 'ALM-Trio-20-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hair removal treatment', 'description': 'Trio laser module (Alma Lasers)', 'interventionNames': ['Device: Hair removal treatment']}], 'interventions': [{'name': 'Hair removal treatment', 'type': 'DEVICE', 'description': 'Axilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers).', 'armGroupLabels': ['Hair removal treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin Care Research, LLC', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Michael Gold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tennessee Clinical Research Center'}, {'name': 'Edwardo Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Skin Care Research, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alma Lasers', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}