Trial · NCT03096444
Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine
NCT03096444, Phase 2, Terminated, Gil Yosipovitch; results first posted 2019-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine. Trials, record NCT03096444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03096444
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine
- NCT number
- NCT03096444
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Gil Yosipovitch
- Conditions
- Pruritus
- Interventions
- Ketamine Hydrochloride, Amitriptyline Hydrochloride, Lidocaine Hydrochloride, Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride, Lipoderm Cream
- First posted
- 2017-03-30
- Last updated
- 2019-07-02
- Results first posted
- 2019-07-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo). | 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". |
| Secondary | Thermal Threshold Detection (Warmth and Heat Pain) | 3 minutes | 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. |
| Secondary | Mechanical Thresholds (Mechanical Detection and Pain). | 5 minutes | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo). | 10 minutes | All subjects received 5 topical cream treatments. | Intensity score | MEAN |
| SECONDARY | Thermal Threshold Detection (Warmth and Heat Pain) | 3 minutes | All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin. | Degrees celsius | MEAN |
| SECONDARY | Mechanical Thresholds (Mechanical Detection and Pain). | 5 minutes | All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin. | mN | MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo). | Topical KeAmLi Combo | 62.7 | Standard Deviation 29.00397851 | Intensity score | |
| Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo). | Topical Ketamine | 63.1 | Standard Deviation 30.11218341 | Intensity score | |
| Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo). | Topical Amitriptyline | 69.2 | Standard Deviation 29.52725816 | Intensity score | |
| Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo). | Topical Lidocaine | 65.8 | Standard Deviation 33.80866222 | Intensity score | |
| Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo). | Topical Vehicle | 61.9 | Standard Deviation 33.95207784 | Intensity score | |
| Thermal Threshold Detection (Warmth and Heat Pain) | Topical KeAmLi Combo | Warm Detection Threshold | 33.6 | Standard Deviation 0.303939003 | Degrees celsius |
| Thermal Threshold Detection (Warmth and Heat Pain) | Topical Ketamine | Warm Detection Threshold | 34.0 | Standard Deviation 1.10853976 | Degrees celsius |
| Thermal Threshold Detection (Warmth and Heat Pain) | Topical Amitriptyline | Warm Detection Threshold | 33.9 | Standard Deviation 0.649150223 | Degrees celsius |
| Thermal Threshold Detection (Warmth and Heat Pain) | Topical Lidocaine | Warm Detection Threshold | 33.7 | Standard Deviation 0.389004867 | Degrees celsius |
| Thermal Threshold Detection (Warmth and Heat Pain) | Topical Vehicle | Warm Detection Threshold | 33.8 | Standard Deviation 0.577436619 | Degrees celsius |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle | 13 | 65 |
| Overall Study | COMPLETED | Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle | 13 | 65 |
| Overall Study | NOT COMPLETED | Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle | 0 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topical KeAmLi Combo | 0 | 13 |
| Total, all-cause mortality | Topical Ketamine | 0 | 13 |
| Total, all-cause mortality | Topical Amitriptyline | 0 | 13 |
| Total, all-cause mortality | Topical Lidocaine | 0 | 13 |
| Total, all-cause mortality | Topical Vehicle | 0 | 13 |
| Total, other adverse events | Topical KeAmLi Combo | 0 | 13 |
| Total, other adverse events | Topical Ketamine | 0 | 13 |
| Total, other adverse events | Topical Amitriptyline | 0 | 13 |
| Total, other adverse events | Topical Lidocaine | 0 | 13 |
| Total, other adverse events | Topical Vehicle | 0 | 13 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers50
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03096444
GET https://conductscience.org/api/trials/v1/NCT03096444/results?page=2