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Efficacy was not seen after interim analysis
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical KeAmLi combo | Experimental | 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. |
|
| Topical ketamine | Experimental | 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. |
|
| Topical amitriptyline | Experimental | 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. |
|
| Topical lidocaine | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Hydrochloride | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo). | 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". | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Thermal Threshold Detection (Warmth and Heat Pain) | 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. | 3 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gil Yosipovitch, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22688895 | Background | 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. Acta Derm Venereol. 2012 Sep;92(5):493-6. doi: 10.2340/00015555-1402. | |
| 23450324 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle | 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. The 5 topical treatments are: Topical 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects received 5 topical cream treatments
| ID | Title | Description |
|---|---|---|
| BG000 | Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle | 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. The 5 topical treatments are: Topical 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo). | 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". | All subjects received 5 topical cream treatments. | Posted | Mean | Standard Deviation | Intensity score | 10 minutes |
|
Data was collect for 1 week from the time of treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical KeAmLi Combo | 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. Ketamine 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leigh Nattkemper | University of Miami | 3055889734 | Lxn202@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2017 | Jan 22, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D000639 | Amitriptyline |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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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.
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|
| Topical vehicle | Placebo Comparator | 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. |
|
|
| Amitriptyline Hydrochloride | Drug | 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. |
|
|
| Lidocaine Hydrochloride | Drug | 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. |
|
|
| Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride | Combination Product | 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. |
|
|
| Lipoderm Cream | Drug | 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. |
|
|
| Mechanical Thresholds (Mechanical Detection and Pain). | 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. | 5 minutes |
| Matterne U, Apfelbacher CJ, Vogelgsang L, Loerbroks A, Weisshaar E. Incidence and determinants of chronic pruritus: a population-based cohort study. Acta Derm Venereol. 2013 Sep 4;93(5):532-7. doi: 10.2340/00015555-1572. |
| 21879245 | Background | Matterne U, Apfelbacher CJ, Loerbroks A, Schwarzer T, Buttner M, Ofenloch R, Diepgen TL, Weisshaar E. Prevalence, correlates and characteristics of chronic pruritus: a population-based cross-sectional study. Acta Derm Venereol. 2011 Oct;91(6):674-9. doi: 10.2340/00015555-1159. |
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| arm skin test area |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| OG001 | Topical Ketamine | 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. Ketamine 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. |
| OG002 | Topical Amitriptyline | 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. Amitriptyline 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. |
| OG003 | Topical Lidocaine | 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. Lidocaine 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. |
| OG004 | Topical Vehicle | 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. Lipoderm 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. |
|
|
| Secondary | Thermal Threshold Detection (Warmth and Heat Pain) | 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. | All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin. | Posted | Mean | Standard Deviation | Degrees celsius | 3 minutes |
|
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| Secondary | Mechanical Thresholds (Mechanical Detection and Pain). | 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. | All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin. | Posted | Mean | Standard Deviation | mN | 5 minutes |
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|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Topical Ketamine | 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. Ketamine 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Topical Amitriptyline | 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. Amitriptyline 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG003 | Topical Lidocaine | 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. Lidocaine 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG004 | Topical Vehicle | 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. Lipoderm 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. | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Heat Pain Threshold |
|
| Mechanical Pain Threshold |
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