Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine

Pruritus Clinical Trial

Official title:

Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03096444
• Other study ID #: 20170087
• Status: Terminated
• Phase: Phase 2
• Start date: May 23, 2017
• Est. completion date: July 21, 2017

Study information

• Verified date: April 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 21, 2017
• Est. primary completion date: July 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Healthy subjects (absence of disease) between 18 and 50 years of age.

2. Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.

3. No history of chronic itch or pain.

4. Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications 48 hours prior to the study visits.

5. Must abstain from the use of moisturizers on the arms the day of study visit.

Exclusion Criteria:

1. Individuals under 18 or over 50 years of age.

2. Inability to complete the required measures.

3. The presence of an itchy skin disease or a painful condition.

4. Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).

5. Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.

6. 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.).

7. Use of emollients on the volar aspects of the forearms arms on the day of the study visit.

8. Use of anti-depressants, anti-psychotics, and illicit drugs.

9. Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.

10. 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.

Related Conditions & MeSH terms

• Pruritus

Intervention

Drug:
• 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.
• 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.
• 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.

Combination Product:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gil Yosipovitch

Country where clinical trial is conducted

United States, 

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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".	10 minutes
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.	3 minutes
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.	5 minutes