Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine

NCT03096444 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 20170087
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pruritus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Thermal Threshold Detection (Warmth and Heat Pain)

  3 minutes

• Mechanical Thresholds (Mechanical Detection and Pain).

  5 minutes

Study Arms (5)

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.

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.

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.

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.

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.

Drug: Lipoderm Cream

Interventions

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.

Also known as: Topical ketamine

Topical ketamine

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.

Also known as: Topical amitriptyline

Topical amitriptyline

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.

Also known as: Topical lidocaine

Topical lidocaine

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.

Also known as: Topical KeAmLi combo

Topical KeAmLi combo

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.

Also known as: Topical vehicle

Topical vehicle

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).
• 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.

Sponsors & Collaborators

• Gil Yosipovitch: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

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MeSH Terms

Conditions

Pruritus

Interventions

Ketamine; Amitriptyline; Lidocaine

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Leigh Nattkemper
• Organization: University of Miami

Lxn202@med.miami.edu

3055889734

Study Officials

• Gil Yosipovitch, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 30, 2017
• Study Start: May 23, 2017
• Primary Completion: July 19, 2017
• Study Completion: July 21, 2017
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)