Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-02-28 @ 9:05 PM
Study NCT ID:
NCT02596750
Status:
COMPLETED
Last Update Posted:
2018-11-27
First Post:
2015-10-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Microneedle Pretreatment on Topical Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dermstudies@ucdavis.edu', 'phone': '916-703-5145', 'title': 'Raja Sivamani MD', 'organization': 'UC Davis Department of Dermatology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event was collected during the study period of which was one day.', 'eventGroups': [{'id': 'EG000', 'title': 'Microneedle Pretreatment', 'description': 'One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.\n\nMicroneedle Roller: 200 micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller\n\nTopical 4% lidocaine', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Microneedle Pretreatment', 'description': 'One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.\n\nSham microneedle Roller: Flat roller without microneedles\n\nTopical 4% lidocaine', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Scale Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Forearms', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator: Microneedle Pretreatment 1 Ventral Forearm', 'description': 'One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points'}, {'id': 'OG001', 'title': 'Sham Comparator: Sham Microneedle Pretreatment', 'description': 'One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '2', 'groupId': 'OG000'}, {'value': '12', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 min', 'description': '100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Forearms', 'denomUnitsSelected': 'Forearms', 'populationDescription': 'All participants'}, {'type': 'PRIMARY', 'title': 'Visual Analog Scale Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Forearm', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator: Microneedle Pretreatment One Ventral Forear', 'description': 'One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points'}, {'id': 'OG001', 'title': 'Sham Comparator: Sham Microneedle Pretreatment', 'description': 'One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '15', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 min', 'description': '100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Forearm', 'denomUnitsSelected': 'Forearm', 'populationDescription': 'All participants'}, {'type': 'PRIMARY', 'title': 'Visual Analog Scale Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Forearm', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator: Microneedle Pretreatment One Ventral Forear', 'description': 'One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points'}, {'id': 'OG001', 'title': 'Sham Comparator: Sham Microneedle Pretreatment', 'description': 'One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '3', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 min', 'description': '100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Forearm', 'denomUnitsSelected': 'Forearm', 'populationDescription': 'All participants'}, {'type': 'PRIMARY', 'title': 'Visual Analog Scale Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Forearm', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator: Microneedle Pretreatment One Ventral Forear', 'description': 'One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points'}, {'id': 'OG001', 'title': 'Sham Comparator: Sham Microneedle Pretreatment', 'description': 'One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 min', 'description': '100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Forearm', 'denomUnitsSelected': 'Forearm', 'populationDescription': 'All participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Microneedle Treatment', 'description': 'Microneedle treatments consisted of pre-treatment with 200 micrometer microneedle rollers and then application of topical 4% lidocaine.'}, {'id': 'FG001', 'title': 'Sham Microneedle', 'description': 'Sham microneedle treatments consisted of pre-treatment with flat microneedle rollers (no needles) and then application of topical 4% lidocaine.'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'comment': '21 participants total started', 'achievements': [{'groupId': 'FG000', 'numUnits': '21', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'comment': '21 participants total completed', 'achievements': [{'groupId': 'FG000', 'numUnits': '21', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': '2 Minutes', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '21', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '21', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': '5 Minutes', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '21', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '21', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': '10 Minutes', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '21', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '21', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': '30 Minutes', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '21', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '21', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Forearm', 'preAssignmentDetails': 'Measure Analysis Population Description: This study incorporated a split body design. 21 participants were studied, each participant had a different treatment on each of their forearms, 42 forearms or data points overall.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'units': 'Forearms', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Microneedle Pretreatment', 'description': 'One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.\n\nMicroneedle Roller: 200-micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller\n\nTopical 4% lidocaine'}, {'id': 'BG001', 'title': 'Sham Microneedle Pretreatment', 'description': 'One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.\n\nSham microneedle Roller: Flat roller without microneedles\n\nTopical 4% lidocaine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '59'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '59'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '59'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'denomUnitsSelected': 'Forearms'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Forearms', 'denomUnitsSelected': 'Forearms', 'populationDescription': '21 participants studied, each participant had a different treatment on each of their forearms, 42 forearms overall.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Forearms', 'populationDescription': "This study uses a 'split body design' where each participant is measured twice (per physical arm). The participants will be half of the arms because each participant had a split body design and so 21 participants will lead to 42 treatment sites."}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each subject will serve as his or her own control. The right forearm and the left forearm will be randomized through a binary randomization to determine whether the right arm will receive microneedle treatment or sham microneedle treatment (roller with no microneedles). This randomization is developed through code in Excel that will result in binary result of either the value 0 or 1 for each subject. For those subjects assigned a binary code of 0, the right forearm will receive microneedle treatment and the left forearm will receive sham microneedle treatment. For those subjects assigned a binary code of 1, the left forearm will receive microneedle treatment and the right forearm will receive sham microneedle treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-02', 'studyFirstSubmitDate': '2015-10-31', 'resultsFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2015-11-03', 'lastUpdatePostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-02', 'studyFirstPostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale Pain', 'timeFrame': '2 min', 'description': '100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.'}, {'measure': 'Visual Analog Scale Pain', 'timeFrame': '5 min', 'description': '100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.'}, {'measure': 'Visual Analog Scale Pain', 'timeFrame': '10 min', 'description': '100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.'}, {'measure': 'Visual Analog Scale Pain', 'timeFrame': '30 min', 'description': '100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '15807814', 'type': 'BACKGROUND', 'citation': 'Sivamani RK, Stoeber B, Wu GC, Zhai H, Liepmann D, Maibach H. Clinical microneedle injection of methyl nicotinate: stratum corneum penetration. Skin Res Technol. 2005 May;11(2):152-6. doi: 10.1111/j.1600-0846.2005.00107.x.'}, {'pmid': '17184159', 'type': 'BACKGROUND', 'citation': 'Sivamani RK, Liepmann D, Maibach HI. Microneedles and transdermal applications. Expert Opin Drug Deliv. 2007 Jan;4(1):19-25. doi: 10.1517/17425247.4.1.19.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the role of microneedle pretreatment in the speed at which anesthesia develops after application of topical 4% lidocaine.', 'detailedDescription': 'This study evaluates whether the time to anesthesia with topical 4% lidocaine can be accelerated with the use of microneedle pretreatment. The study will evaluate the anesthesia as a randomized split-body study where each subject serves as their own control. The study will be performed on the volar forearm. Prior to application of the topical 4% lidocaine, one arm will be exposed to a microneedle pretreatment on a microneedle roller and the other arm will be exposed to sham microneedle treatment that will consist of a flat roller with no microneedles. Then pain will be assessed with the use of a spring loaded needle lancet that will be applied at 2 min, 5 min, 10 min, and 30 minutes after treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Allergy to lidocaine\n* Smokers'}, 'identificationModule': {'nctId': 'NCT02596750', 'briefTitle': 'The Effect of Microneedle Pretreatment on Topical Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'The Effect of Microneedle Pretreatment on Topical Anesthesia', 'orgStudyIdInfo': {'id': '252160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Microneedle Pretreatment', 'description': 'One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 4 min, 10 min, and 30 min time points.', 'interventionNames': ['Device: Microneedle Roller']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Microneedle Pretreatment', 'description': 'One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 4 min, 10 min, and 30 min time points.', 'interventionNames': ['Device: Sham microneedle Roller']}], 'interventions': [{'name': 'Microneedle Roller', 'type': 'DEVICE', 'description': '200 micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller', 'armGroupLabels': ['Microneedle Pretreatment']}, {'name': 'Sham microneedle Roller', 'type': 'DEVICE', 'description': 'Flat roller without microneedles', 'armGroupLabels': ['Sham Microneedle Pretreatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Raja K Sivamani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}