PruritusPhase 2NCT03096444
Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine
A Phase 2 study testing Ketamine Hydrochloride, Amitriptyline Hydrochloride and Lidocaine Hydrochloride in people with Pruritus, run by Gil Yosipovitch at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pruritus
- What is being tested?
- Ketamine Hydrochloride, Amitriptyline Hydrochloride and Lidocaine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 21 Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects (absence of disease) between 18 and 50 years of age.
- Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
- No history of chronic itch or pain.
- Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications 48 hours prior to the study visits.
- Must abstain from the use of moisturizers on the arms the day of study visit.
Who cannot join
- Individuals under 18 or over 50 years of age.
- Inability to complete the required measures.
- The presence of an itchy skin disease or a painful condition.
- Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
- Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
- 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.).
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- Use of emollients on the volar aspects of the forearms arms on the day of the study visit.
- Use of anti-depressants, anti-psychotics, and illicit drugs.
- Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Pruritus
- Being tested
- Ketamine Hydrochloride, Amitriptyline Hydrochloride, Lidocaine Hydrochloride, Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride, Lipoderm Cream
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Also called Topical ketamine
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.
Amitriptyline HydrochlorideDrug
Also called Topical amitriptyline
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 HydrochlorideDrug
Also called Topical lidocaine
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 hydrochlorideCombination product
Also called Topical KeAmLi combo
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 CreamDrug
Also called Topical vehicle
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride |
| 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. Receives: Drug: Ketamine Hydrochloride |
| 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. Receives: Drug: Amitriptyline Hydrochloride |
| 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. Receives: Drug: Lidocaine Hydrochloride |
| 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. Receives: Drug: Lipoderm Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 10 minutes
Secondary outcomes (2)
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.
Measured: 3 minutes
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start23 May 2017
- Primary completion19 Jul 2017
- Study completion21 Jul 2017
Why it stopped: Efficacy was not seen after interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gil Yosipovitch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gil Yosipovitch, University of Miami
- Investigators
- Gil Yosipovitch, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096444
- Sponsor's protocol ID
- 20170087
- Status last verified
- Apr 2019
- First submitted
- 16 Mar 2017
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22688895Matterne 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.
PubMed 23450324Matterne 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.
PubMed 21879245Leknes SG, Bantick S, Willis CM, Wilkinson JD, Wise RG, Tracey I. Itch and motivation to scratch: an investigation of the central and peripheral correlates of allergen- and histamine-induced itch in humans. J Neurophysiol. 2007 Jan;97(1):415-22. doi: 10.1152/jn.00070.2006. Epub 2006 Aug 16.
PubMed 16914620Wahlgren CF. Itch and atopic dermatitis: an overview. J Dermatol. 1999 Nov;26(11):770-9. doi: 10.1111/j.1346-8138.1999.tb02090.x.
PubMed 10635621Brenaut E, Garlantezec R, Talour K, Misery L. Itch characteristics in five dermatoses: non-atopic eczema, atopic dermatitis, urticaria, psoriasis and scabies. Acta Derm Venereol. 2013 Sep 4;93(5):573-4. doi: 10.2340/00015555-1599. No abstract available.
PubMed 23722181Carroll CL, Balkrishnan R, Feldman SR, Fleischer AB Jr, Manuel JC. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005 May-Jun;22(3):192-9. doi: 10.1111/j.1525-1470.2005.22303.x.
PubMed 15916563Patel T, Yosipovitch G. Therapy of pruritus. Expert Opin Pharmacother. 2010 Jul;11(10):1673-82. doi: 10.1517/14656566.2010.484420.
PubMed 20426711Kopsky DJ, Keppel Hesselink JM, Bhaskar A, Hariton G, Romanenko V, Casale R. Analgesic effects of topical ketamine. Minerva Anestesiol. 2015 Apr;81(4):440-9. Epub 2014 May 22.
PubMed 24847738Coggeshall RE, Carlton SM. Ultrastructural analysis of NMDA, AMPA, and kainate receptors on unmyelinated and myelinated axons in the periphery. J Comp Neurol. 1998 Feb 2;391(1):78-86. doi: 10.1002/(sici)1096-9861(19980202)391:13.3.co;2-8.
PubMed 9527543Carlton SM, Coggeshall RE. Inflammation-induced changes in peripheral glutamate receptor populations. Brain Res. 1999 Feb 27;820(1-2):63-70. doi: 10.1016/s0006-8993(98)01328-6.
PubMed 10023031Davidson EM, Coggeshall RE, Carlton SM. Peripheral NMDA and non-NMDA glutamate receptors contribute to nociceptive behaviors in the rat formalin test. Neuroreport. 1997 Mar 3;8(4):941-6. doi: 10.1097/00001756-199703030-00025.
PubMed 9141069Mehta AK, Halder S, Khanna N, Tandon OP, Singh UR, Sharma KK. Role of NMDA and opioid receptors in neuropathic pain induced by chronic constriction injury of sciatic nerve in rats. J Basic Clin Physiol Pharmacol. 2012;23(2):49-55. doi: 10.1515/jbcpp-2012-0003.
PubMed 23091273Zhou S, Bonasera L, Carlton SM. Peripheral administration of NMDA, AMPA or KA results in pain behaviors in rats. Neuroreport. 1996 Mar 22;7(4):895-900. doi: 10.1097/00001756-199603220-00012.
PubMed 8724668Tandon OP, Mehta AK, Halder S, Khanna N, Sharma KK. Peripheral interaction of opioid and NMDA receptors in inflammatory pain in rats. Indian J Physiol Pharmacol. 2010 Jan-Mar;54(1):21-31.
PubMed 21046916
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine
- ClinicalTrials.gov ID
- NCT03096444
- Acronym / sponsor ID
- 20170087
- Conditions
- Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Efficacy was not seen after interim analysis
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Gil YosipovitchUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Topical KeAmLi combo | Experimental | Combination Product: Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochlorideTopical 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 | Drug: Ketamine HydrochlorideTopical 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 | Drug: Amitriptyline HydrochlorideTopical 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 | Drug: Lidocaine HydrochlorideTopical 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 vehicle | Placebo comparator | Drug: Lipoderm CreamTopical 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects (absence of disease) between 18 and 50 years of age.
- Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
- No history of chronic itch or pain.
- Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications 48 hours prior to the study visits.
- Must abstain from the use of moisturizers on the arms the day of study visit.
Key exclusion criteria (10 listed)
- Individuals under 18 or over 50 years of age.
- Inability to complete the required measures.
- The presence of an itchy skin disease or a painful condition.
- Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
- Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine HydrochlorideAlso: Topical ketamine2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits. | Drug | Topical ketamine |
| Amitriptyline HydrochlorideAlso: Topical amitriptyline2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits. | Drug | Topical amitriptyline |
| Lidocaine HydrochlorideAlso: Topical lidocaine2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits. | Drug | Topical lidocaine |
| Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochlorideAlso: Topical KeAmLi combo2g 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. | Combination product | Topical KeAmLi combo |
| Lipoderm CreamAlso: Topical vehicle2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits. | Drug | Topical vehicle |
Primary outcome
Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo).
Time frame: 10 minutes
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".
2 secondary outcomes
Thermal Threshold Detection (Warmth and Heat Pain)
Time frame: 3 minutes
Mechanical Thresholds (Mechanical Detection and Pain).
Time frame: 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22688895Weisshaar 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.
- Background: PubMed 23450324Matterne 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.
- Background: PubMed 21879245Matterne 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.
- Background: PubMed 16914620Leknes SG, Bantick S, Willis CM, Wilkinson JD, Wise RG, Tracey I. Itch and motivation to scratch: an investigation of the central and peripheral correlates of allergen- and histamine-induced itch in humans. J Neurophysiol. 2007 Jan;97(1):415-22. doi: 10.1152/jn.00070.2006. Epub 2006 Aug 16.
- Background: PubMed 10635621Wahlgren CF. Itch and atopic dermatitis: an overview. J Dermatol. 1999 Nov;26(11):770-9. doi: 10.1111/j.1346-8138.1999.tb02090.x.
- Background: PubMed 23722181Brenaut E, Garlantezec R, Talour K, Misery L. Itch characteristics in five dermatoses: non-atopic eczema, atopic dermatitis, urticaria, psoriasis and scabies. Acta Derm Venereol. 2013 Sep 4;93(5):573-4. doi: 10.2340/00015555-1599. No abstract available.
- Background: PubMed 15916563Carroll CL, Balkrishnan R, Feldman SR, Fleischer AB Jr, Manuel JC. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005 May-Jun;22(3):192-9. doi: 10.1111/j.1525-1470.2005.22303.x.
- Background: PubMed 20426711Patel T, Yosipovitch G. Therapy of pruritus. Expert Opin Pharmacother. 2010 Jul;11(10):1673-82. doi: 10.1517/14656566.2010.484420.
- Background: PubMed 24847738Kopsky DJ, Keppel Hesselink JM, Bhaskar A, Hariton G, Romanenko V, Casale R. Analgesic effects of topical ketamine. Minerva Anestesiol. 2015 Apr;81(4):440-9. Epub 2014 May 22.
- Background: PubMed 9527543Coggeshall RE, Carlton SM. Ultrastructural analysis of NMDA, AMPA, and kainate receptors on unmyelinated and myelinated axons in the periphery. J Comp Neurol. 1998 Feb 2;391(1):78-86. doi: 10.1002/(sici)1096-9861(19980202)391:13.3.co;2-8.
- Background: PubMed 10023031Carlton SM, Coggeshall RE. Inflammation-induced changes in peripheral glutamate receptor populations. Brain Res. 1999 Feb 27;820(1-2):63-70. doi: 10.1016/s0006-8993(98)01328-6.
- Background: PubMed 9141069Davidson EM, Coggeshall RE, Carlton SM. Peripheral NMDA and non-NMDA glutamate receptors contribute to nociceptive behaviors in the rat formalin test. Neuroreport. 1997 Mar 3;8(4):941-6. doi: 10.1097/00001756-199703030-00025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gil Yosipovitch, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine Hydrochloride, Amitriptyline Hydrochloride and Lidocaine Hydrochloride in people with Pruritus, run by Gil Yosipovitch at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo). (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03096444, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.