{"protocolSection":{"identificationModule":{"nctId":"NCT03096444","orgStudyIdInfo":{"id":"20170087"},"organization":{"fullName":"University of Miami","class":"OTHER"},"briefTitle":"Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine","officialTitle":"Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine"},"statusModule":{"statusVerifiedDate":"2019-04","overallStatus":"TERMINATED","whyStopped":"Efficacy was not seen after interim analysis","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-05-23","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2017-07-19","type":"ACTUAL"},"completionDateStruct":{"date":"2017-07-21","type":"ACTUAL"},"studyFirstSubmitDate":"2017-03-16","studyFirstSubmitQcDate":"2017-03-24","studyFirstPostDateStruct":{"date":"2017-03-30","type":"ACTUAL"},"resultsFirstSubmitDate":"2019-02-19","resultsFirstSubmitQcDate":"2019-06-24","resultsFirstPostDateStruct":{"date":"2019-07-02","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-06-24","lastUpdatePostDateStruct":{"date":"2019-07-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Gil Yosipovitch","investigatorTitle":"Professor","investigatorAffiliation":"University of Miami"},"leadSponsor":{"name":"Gil Yosipovitch","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to examine the antipruritic efficacy of topical ketamine, amitriptyline, lidocaine, and a tri-combination of ketamine, amitriptyline and lidocaine (hereafter referred to as \"KeAmLi\") using non-histaminergic itch provocations in healthy volunteers. The primary outcome is itch reduction (AUC) between the vehicle and active treatment (KeAmLi-combo). Secondary outcomes include modality-specific analgesic properties of the topically applied ketamine, amitriptyline, lidocaine, and KeAmLi-combo to controlled quantitative thermal and mechanical stimuli, which can improve our understanding of the mechanism of action of these substances in the context of topical therapy.","detailedDescription":"This is a double-blind, vehicle-controlled study to evaluate the antipruritic efficacy of topical ketamine, amitriptyline, lidocaine, and a tri-combination of ketamine, amitriptyline and lidocaine (hereafter referred to as \"KeAmLi\") using non-histaminergic itch provocations in healthy volunteers. Each participant will be pre-treated with the vehicle and 4 active topical creams, over two study visits (3 treatments on the 1st visit and 2 treatment on the 2nd visit). Each treatment will be applied to the randomized forearm test area for 30 minute, and then sensory testing will be performed. Sensory testing includes thermal and mechanical stimuli, and itch induction using the plant cowhage. These tests will reveal mechanistic information and potential cellular and molecular targets for improved antipruritic and analgesic therapies."},"conditionsModule":{"conditions":["Pruritus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","interventionModelDescription":"The antipruritic effect of 4 topical treatments and 1 vehicle treatment will be explored in each subject. Study visit 1 will consist of testing 3 topical formulations, and study visit 2 will test the remaining 2 topical formulations in each subject.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":13,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Topical KeAmLi combo","type":"EXPERIMENTAL","description":"Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.","interventionNames":["Combination Product: Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride"]},{"label":"Topical ketamine","type":"EXPERIMENTAL","description":"Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.","interventionNames":["Drug: Ketamine Hydrochloride"]},{"label":"Topical amitriptyline","type":"EXPERIMENTAL","description":"Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.","interventionNames":["Drug: Amitriptyline Hydrochloride"]},{"label":"Topical lidocaine","type":"EXPERIMENTAL","description":"Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.","interventionNames":["Drug: Lidocaine Hydrochloride"]},{"label":"Topical vehicle","type":"PLACEBO_COMPARATOR","description":"Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.","interventionNames":["Drug: Lipoderm Cream"]}],"interventions":[{"type":"DRUG","name":"Ketamine Hydrochloride","description":"2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.","armGroupLabels":["Topical ketamine"],"otherNames":["Topical ketamine"]},{"type":"DRUG","name":"Amitriptyline Hydrochloride","description":"2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.","armGroupLabels":["Topical amitriptyline"],"otherNames":["Topical amitriptyline"]},{"type":"DRUG","name":"Lidocaine Hydrochloride","description":"2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.","armGroupLabels":["Topical lidocaine"],"otherNames":["Topical lidocaine"]},{"type":"COMBINATION_PRODUCT","name":"Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride","description":"2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.","armGroupLabels":["Topical KeAmLi combo"],"otherNames":["Topical KeAmLi combo"]},{"type":"DRUG","name":"Lipoderm Cream","description":"2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.","armGroupLabels":["Topical vehicle"],"otherNames":["Topical vehicle"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo).","description":"Peak itch intensity between the vehicle and 4 other active treatments (individual ketamine, amitriptyline, or lidocaine, and KeAmLi-combo). Itch intensity was measured on a 100mm scale visual analog scale for 10 minutes. 0 was weighted with \"no itch\" and 100 was weighted with \"most itch imaginable\".","timeFrame":"10 minutes"}],"secondaryOutcomes":[{"measure":"Thermal Threshold Detection (Warmth and Heat Pain)","description":"Two standardized quantitative sensory tests are performed to measure warmth detection threshold (assesses the threshold of which warmth sensation is first detected) and heat pain threshold (assesses the threshold at which heat pain sensation is first detected). Measured in change in celsius.","timeFrame":"3 minutes"},{"measure":"Mechanical Thresholds (Mechanical Detection and Pain).","description":"Assess mechanical detection and pain thresholds using von Frey filaments stimulators (measured in force mN) to calculate the final threshold as the geometric mean of five series of ascending and descending stimuli.","timeFrame":"5 minutes"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Healthy subjects (absence of disease) between 18 and 50 years of age.\n2. Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.\n3. No history of chronic itch or pain.\n4. Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications 48 hours prior to the study visits.\n5. Must abstain from the use of moisturizers on the arms the day of study visit.\n\nExclusion Criteria:\n\n1. Individuals under 18 or over 50 years of age.\n2. Inability to complete the required measures.\n3. The presence of an itchy skin disease or a painful condition.\n4. Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).\n5. Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.\n6. Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception 48 hours prior to the study visits (e.g. antihistamines, anesthetics, anti-inflammatories, opioids, neuroleptics, etc.).\n7. Use of emollients on the volar aspects of the forearms arms on the day of the study visit.\n8. Use of anti-depressants, anti-psychotics, and illicit drugs.\n9. Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.\n10. Known history of anaphylactic shock, or allergy to cowhage and/or known adverse reactions to lidocaine (or other local anesthetics of the amide type), ketamine or amitriptyline.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"50 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Gil Yosipovitch, MD","affiliation":"University of Miami","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Miami","city":"Miami","state":"Florida","zip":"33136","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}}]},"referencesModule":{"references":[{"pmid":"22688895","type":"BACKGROUND","citation":"Weisshaar E, Gieler U, Kupfer J, Furue M, Saeki H, Yosipovitch G; International Forum on the Study of Itch. Questionnaires to assess chronic itch: a consensus paper of the special interest group of the International Forum on the Study of Itch. 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Dermatol Surg. 2001 Dec;27(12):1019-26. doi: 10.1046/j.1524-4725.2001.01855.x."},{"pmid":"21423808","type":"BACKGROUND","citation":"Papoiu AD, Tey HL, Coghill RC, Wang H, Yosipovitch G. Cowhage-induced itch as an experimental model for pruritus. A comparative study with histamine-induced itch. PLoS One. 2011 Mar 14;6(3):e17786. doi: 10.1371/journal.pone.0017786."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"typeUnitsAnalyzed":"4x4cm skin arm test area","groups":[{"id":"FG000","title":"Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle","description":"Each participant will receive topical cream treatments applied for 30 minutes to 5 separate 4 x 4 cm predefined skin areas on the ventral forearms.\n\nThe 5 topical treatments are:\n\nTopical KeAmLi Combo: Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) Topical ketamine: 10% Topical amitriptyline: 5% Topical lidocaine: 5% Topical vehicle: PCCA Lipoderm cream"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"13","numUnits":"65"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"13","numUnits":"65"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0","numUnits":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All subjects received 5 topical cream treatments","typeUnitsAnalyzed":"arm skin test area","groups":[{"id":"BG000","title":"Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle","description":"Each participant will receive topical cream treatments applied for 30 minutes to 5 separate 4 x 4 cm predefined skin areas on the ventral forearms.\n\nThe 5 topical treatments are:\n\nTopical KeAmLi Combo: Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) Topical ketamine: 10% Topical amitriptyline: 5% Topical lidocaine: 5% Topical vehicle: PCCA Lipoderm cream"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"13"}]},{"units":"arm skin test area","counts":[{"groupId":"BG000","value":"65"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","denomUnitsSelected":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"13"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","denomUnitsSelected":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"9"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","denomUnitsSelected":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"5"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"8"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","denomUnitsSelected":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"9"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo).","description":"Peak itch intensity between the vehicle and 4 other active treatments (individual ketamine, amitriptyline, or lidocaine, and KeAmLi-combo). Itch intensity was measured on a 100mm scale visual analog scale for 10 minutes. 0 was weighted with \"no itch\" and 100 was weighted with \"most itch imaginable\".","populationDescription":"All subjects received 5 topical cream treatments.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Intensity score","timeFrame":"10 minutes","groups":[{"id":"OG000","title":"Topical KeAmLi Combo","description":"Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nKetamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG001","title":"Topical Ketamine","description":"Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nKetamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG002","title":"Topical Amitriptyline","description":"Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nAmitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG003","title":"Topical Lidocaine","description":"Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nLidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG004","title":"Topical Vehicle","description":"Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nLipoderm Cream: 2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"62.7","spread":"29.00397851"},{"groupId":"OG001","value":"63.1","spread":"30.11218341"},{"groupId":"OG002","value":"69.2","spread":"29.52725816"},{"groupId":"OG003","value":"65.8","spread":"33.80866222"},{"groupId":"OG004","value":"61.9","spread":"33.95207784"}]}]}]},{"type":"SECONDARY","title":"Thermal Threshold Detection (Warmth and Heat Pain)","description":"Two standardized quantitative sensory tests are performed to measure warmth detection threshold (assesses the threshold of which warmth sensation is first detected) and heat pain threshold (assesses the threshold at which heat pain sensation is first detected). Measured in change in celsius.","populationDescription":"All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Degrees celsius","timeFrame":"3 minutes","groups":[{"id":"OG000","title":"Topical KeAmLi Combo","description":"Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nKetamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG001","title":"Topical Ketamine","description":"Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nKetamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG002","title":"Topical Amitriptyline","description":"Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nAmitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG003","title":"Topical Lidocaine","description":"Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nLidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG004","title":"Topical Vehicle","description":"Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nLipoderm Cream: 2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"13"}]}],"classes":[{"title":"Warm Detection Threshold","categories":[{"measurements":[{"groupId":"OG000","value":"33.6","spread":"0.303939003"},{"groupId":"OG001","value":"34.0","spread":"1.10853976"},{"groupId":"OG002","value":"33.9","spread":"0.649150223"},{"groupId":"OG003","value":"33.7","spread":"0.389004867"},{"groupId":"OG004","value":"33.8","spread":"0.577436619"}]}]},{"title":"Heat Pain Threshold","categories":[{"measurements":[{"groupId":"OG000","value":"39.8","spread":"2.401845207"},{"groupId":"OG001","value":"40.0","spread":"2.2098072"},{"groupId":"OG002","value":"40.0","spread":"2.80388162"},{"groupId":"OG003","value":"39.4","spread":"2.305045253"},{"groupId":"OG004","value":"39.7","spread":"2.227588606"}]}]}]},{"type":"SECONDARY","title":"Mechanical Thresholds (Mechanical Detection and Pain).","description":"Assess mechanical detection and pain thresholds using von Frey filaments stimulators (measured in force mN) to calculate the final threshold as the geometric mean of five series of ascending and descending stimuli.","populationDescription":"All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mN","timeFrame":"5 minutes","groups":[{"id":"OG000","title":"Topical KeAmLi Combo","description":"Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nKetamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG001","title":"Topical Ketamine","description":"Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nKetamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG002","title":"Topical Amitriptyline","description":"Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nAmitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG003","title":"Topical Lidocaine","description":"Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nLidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."},{"id":"OG004","title":"Topical Vehicle","description":"Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nLipoderm Cream: 2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"13"}]}],"classes":[{"title":"Mechanical Detection Threshold","categories":[{"measurements":[{"groupId":"OG000","value":"3.519376956","spread":"0.122225324"},{"groupId":"OG001","value":"3.464204768","spread":"0.16205246"},{"groupId":"OG002","value":"3.573423965","spread":"0.141531726"},{"groupId":"OG003","value":"3.546037659","spread":"0.157416303"},{"groupId":"OG004","value":"3.525692637","spread":"0.169487169"}]}]},{"title":"Mechanical Pain Threshold","categories":[{"measurements":[{"groupId":"OG000","value":"152.3293608","spread":"90.32609423"},{"groupId":"OG001","value":"135.9","spread":"121.5234567"},{"groupId":"OG002","value":"152.4768146","spread":"114.1149716"},{"groupId":"OG003","value":"126.9","spread":"106.9414678"},{"groupId":"OG004","value":"148.7138273","spread":"104.3418768"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Data was collect for 1 week from the time of treatment.","eventGroups":[{"id":"EG000","title":"Topical KeAmLi Combo","description":"Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nKetamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.","deathsNumAffected":0,"deathsNumAtRisk":13,"seriousNumAffected":0,"seriousNumAtRisk":13,"otherNumAffected":0,"otherNumAtRisk":13},{"id":"EG001","title":"Topical Ketamine","description":"Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nKetamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.","deathsNumAffected":0,"deathsNumAtRisk":13,"seriousNumAffected":0,"seriousNumAtRisk":13,"otherNumAffected":0,"otherNumAtRisk":13},{"id":"EG002","title":"Topical Amitriptyline","description":"Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nAmitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.","deathsNumAffected":0,"deathsNumAtRisk":13,"seriousNumAffected":0,"seriousNumAtRisk":13,"otherNumAffected":0,"otherNumAtRisk":13},{"id":"EG003","title":"Topical Lidocaine","description":"Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nLidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.","deathsNumAffected":0,"deathsNumAtRisk":13,"seriousNumAffected":0,"seriousNumAtRisk":13,"otherNumAffected":0,"otherNumAtRisk":13},{"id":"EG004","title":"Topical Vehicle","description":"Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.\n\nLipoderm Cream: 2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.","deathsNumAffected":0,"deathsNumAtRisk":13,"seriousNumAffected":0,"seriousNumAtRisk":13,"otherNumAffected":0,"otherNumAtRisk":13}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Leigh Nattkemper","organization":"University of Miami","email":"Lxn202@med.miami.edu","phone":"3055889734"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2017-03-29","uploadDate":"2019-01-22T17:13","filename":"Prot_SAP_000.pdf","size":2043741}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D011537","term":"Pruritus"}],"ancestors":[{"id":"D012871","term":"Skin Diseases"},{"id":"D017437","term":"Skin and Connective Tissue Diseases"},{"id":"D012877","term":"Skin Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D007649","term":"Ketamine"},{"id":"D000639","term":"Amitriptyline"},{"id":"D008012","term":"Lidocaine"}],"ancestors":[{"id":"D003510","term":"Cyclohexanes"},{"id":"D003516","term":"Cycloparaffins"},{"id":"D006840","term":"Hydrocarbons, Alicyclic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D003986","term":"Dibenzocycloheptenes"},{"id":"D001567","term":"Benzocycloheptenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D000083","term":"Acetanilides"},{"id":"D000813","term":"Anilides"},{"id":"D000577","term":"Amides"},{"id":"D000814","term":"Aniline Compounds"},{"id":"D000588","term":"Amines"}]}},"hasResults":true}