Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-07 @ 1:50 AM
Study NCT ID:
NCT03366194
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2017-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Clinical Efficacy And Safety Of SkinStylus Microneedling System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Support@skinstylus.com', 'phone': '(480) 656-2251', 'title': 'Study Coordinator', 'organization': 'Esthetic Education LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'SkinStylus Sterilock System Intervention', 'description': 'Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.\n\nSkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 2, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hyperpigmentation transient', 'notes': 'Hyperpigmentation of treatment area that lasts longer than 2 weeks but less than six months', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Improvement Assessed Using the VAS Scar Scoring System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.\n\nSkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days from date of last treatment', 'description': 'The Visual Analog Scale Scar Scoring System (VAS Scar Scale) is a validated scar assessment scale with a minimum scar improvement value of 0.0 cm on one end of a 10.0 cm long line and 10.0 cm on the other end. The 0.0 cm represents "no change" in the appearance of the scar while 10.0 cm represents "complete resolution" of the scar.\n\nA panel of 3 expert graders viewed images of the treatment area and the control area before treatment and 90 days after the last treatment. The difference between the measurements taken at baseline and measurements taken two weeks following the end of the treatment of the treatment area was calculated for each participant, for each grader. The difference of all three graders analysis for each subject was averaged. Those participants with a VAS score on the treatment side that met the MCID of an improvement of at least 1.0 cm were identified in the results as "responders". A higher score is a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.\n\nSkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.\n\nPrior to any treatment, each subject shall self-evaluate the appearance of their scar using the validated Self Assessed Scar Improvement Scale.\n\n90 days after the last treatment, each subject shall self-evaluate the appearance of the treated area of their scar using the validated Self Assessed Scar Improvement Scale.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days from date of last treatment', 'description': 'The Self-Assessed Scar Improvement Scale is a validated 6-point scale (-1 to 4) describing the patient\'s opinion regarding the overall improvement of the scar after treatment with "4" constituting the patient believing that the scar had a "75%-99%" improvement, "3" constituting a "50%-75%" improvement, "2" constituting a "25%-50%" improvement, "1" constituting a "1%-25%" improvement, "0" constituting "no change", and "-1" constituting an "exacerbation of the scar\'s appearance". A higher score means a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SkinStylus Sterilock System Intervention', 'description': 'Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.\n\nSkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental', 'description': 'Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.\n\nSkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Chest vs abdomen', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-04', 'size': 1251428, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-11T14:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '3\\. The trial shall be blinded and bias minimized in that three (3) physicians who are either dermatologists or plastic surgeons (and not affiliated with the trial or Esthetic Education LLC) shall review the baseline and treatment photographs and score them using the VAS scale (Visual Analogue Scale).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'dispFirstSubmitDate': '2019-02-11', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-16', 'studyFirstSubmitDate': '2017-12-04', 'dispFirstSubmitQcDate': '2022-04-16', 'resultsFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2017-12-04', 'dispFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-16', 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Improvement Assessed Using the VAS Scar Scoring System', 'timeFrame': '90 days from date of last treatment', 'description': 'The Visual Analog Scale Scar Scoring System (VAS Scar Scale) is a validated scar assessment scale with a minimum scar improvement value of 0.0 cm on one end of a 10.0 cm long line and 10.0 cm on the other end. The 0.0 cm represents "no change" in the appearance of the scar while 10.0 cm represents "complete resolution" of the scar.\n\nA panel of 3 expert graders viewed images of the treatment area and the control area before treatment and 90 days after the last treatment. The difference between the measurements taken at baseline and measurements taken two weeks following the end of the treatment of the treatment area was calculated for each participant, for each grader. The difference of all three graders analysis for each subject was averaged. Those participants with a VAS score on the treatment side that met the MCID of an improvement of at least 1.0 cm were identified in the results as "responders". A higher score is a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey', 'timeFrame': '90 days from date of last treatment', 'description': 'The Self-Assessed Scar Improvement Scale is a validated 6-point scale (-1 to 4) describing the patient\'s opinion regarding the overall improvement of the scar after treatment with "4" constituting the patient believing that the scar had a "75%-99%" improvement, "3" constituting a "50%-75%" improvement, "2" constituting a "25%-50%" improvement, "1" constituting a "1%-25%" improvement, "0" constituting "no change", and "-1" constituting an "exacerbation of the scar\'s appearance". A higher score means a better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cicatrix, Hypertrophic']}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to provide objective evidence the SkinStylus may be used safely and effectively for the treatment of ventral torso hypertrophic scars.', 'detailedDescription': '1. The SkinStylus has been designated as a non-significant risk and therefore will be granted an Investigational Device Exemption (IDE). There are no meaningful changes to the SkinStylus® instructions for use and specifically no new risks will be introduced.\n2. Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar. This is entirely voluntary and participants may decline the treatment if they wish.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. at least 23 years old\n2. shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.\n3. The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.\n\nExclusion Criteria:\n\n1. Pregnancy or chance of pregnancy\n2. Currently taking Coumadin/Warfarin® or heparin\n3. Diagnosis of any type of bleeding disorder\n4. Any history of keloid formation\n5. Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity\n6. Diagnosis of mental disorders requiring inpatient treatment\n7. Presence of metal implants around the proposed treatment areas\n8. Diagnosis of any undefined wasting disease (Cachexia for example)\n9. Diagnosis of an active infection in the treatment area other than mild acne\n10. Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy\n11. Diagnosis of severe cardiovascular and cerebrovascular disease\n12. Diagnosis of renal failure'}, 'identificationModule': {'nctId': 'NCT03366194', 'briefTitle': 'The Clinical Efficacy And Safety Of SkinStylus Microneedling System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Esthetic Education LLC'}, 'officialTitle': 'The Clinical Efficacy And Safety Of SkinStylus Microneedling System for Ventral Torso Hypertrophic Scars: Clinical Results With 30 Patients', 'orgStudyIdInfo': {'id': '20172466 2017-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.', 'interventionNames': ['Device: SkinStylus Sterilock System']}], 'interventions': [{'name': 'SkinStylus Sterilock System', 'type': 'DEVICE', 'description': 'Microneedling device will be used to treat ventral hypertrophic scars.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Esthetic Education LLC', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Toni Stockton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator for Esthetic Education LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esthetic Education LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}