Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT06336135
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2024-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reduction in Symptoms After Laser Therapy With Acorn aHFS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in severity and duration of symptoms', 'timeFrame': '2 weeks', 'description': 'Each region of interest will be evaluated daily for the severity and duration of eight symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['skin, aging, rejuvenation, laser resurfacing, autologous secretome'], 'conditions': ['Skin Aging']}, 'descriptionModule': {'briefSummary': 'This study evaluates the severity and duration of symptoms experienced after laser therapy comparing four post-procedure topical products. Each product is applied to an individual region of interest (5 cm diameter) on the back or décolleté according to randomization code after laser therapy. The subject, blind to the product applied to each of 4 regions of interest, assesses eight symptoms daily for 14 days. Photography is performed daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects are healthy adults receiving laser skin rejuvenation therapy.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or Female\n* Age: ≥18 and ≤60 years\n* Any skin tone Fitzpatrick score 1-2 (light), 3-4 (medium), 5-6 (dark)\n* Competent and willing to provide written, informed consent to participate in all study activities\n\nExclusion Criteria:\n\n* Pregnant women\n* Are participating/have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by Sponsor\n* Use of retinoids 7 days prior to the procedure\n* Active cutaneous infections in the treatment area\n* Diseases that could inhibit healing, such as scleroderma, or other cutaneous conditions that could confound study results\n* Subjects unable to communicate with the investigator and staff\n* Any health condition that in the investigator's opinion should preclude participation in this study"}, 'identificationModule': {'nctId': 'NCT06336135', 'briefTitle': 'Reduction in Symptoms After Laser Therapy With Acorn aHFS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acorn Biolabs Inc.'}, 'officialTitle': 'A Prospective, Single-blind, Randomized, Placebo-controlled, Clinical Trial Evaluating Reduction in Severity and Duration of Symptoms After Laser Therapy With Acorn aHFS', 'orgStudyIdInfo': {'id': '23-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'autologous hair follicle derived secretome', 'type': 'OTHER', 'otherNames': ['Acorn autologous hair follicle secretome', 'aHFS'], 'description': 'aHFS is a cosmetic topical intended to be applied to the human body after skin resurfacing cosmetic procedures. aHFS is produced from the plucked hair follicles of each individual, making it autologous.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L3R0M3', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Rejuuv Medi Spa', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}], 'overallOfficials': [{'name': 'Lisa Campbell, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Acorn Biolabs Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acorn Biolabs Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}