Trial Outcomes & Findings for Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine (NCT NCT03096444)

Last Updated: 2019-07-02

Results Overview

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".

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

10 minutes

Results posted on

2019-07-02

Participant Flow

Unit of analysis: 4x4cm skin arm test area

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	13 65
Overall Study COMPLETED	13 65
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle n=65 arm skin test area 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes

Population: All subjects received 5 topical cream treatments.

Outcome measures

Outcome measures
Measure	Topical KeAmLi Combo n=13 Participants 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.	Topical Ketamine n=13 Participants 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.	Topical Amitriptyline n=13 Participants 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.	Topical Lidocaine n=13 Participants 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.	Topical Vehicle n=13 Participants 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.
Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo).	62.7 Intensity score Standard Deviation 29.00397851	63.1 Intensity score Standard Deviation 30.11218341	69.2 Intensity score Standard Deviation 29.52725816	65.8 Intensity score Standard Deviation 33.80866222	61.9 Intensity score Standard Deviation 33.95207784

SECONDARY outcome

Timeframe: 3 minutes

Population: All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin.

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.

Outcome measures

Outcome measures
Measure	Topical KeAmLi Combo n=13 Participants 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.	Topical Ketamine n=13 Participants 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.	Topical Amitriptyline n=13 Participants 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.	Topical Lidocaine n=13 Participants 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.	Topical Vehicle n=13 Participants 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.
Thermal Threshold Detection (Warmth and Heat Pain) Warm Detection Threshold	33.6 Degrees celsius Standard Deviation 0.303939003	34.0 Degrees celsius Standard Deviation 1.10853976	33.9 Degrees celsius Standard Deviation 0.649150223	33.7 Degrees celsius Standard Deviation 0.389004867	33.8 Degrees celsius Standard Deviation 0.577436619
Thermal Threshold Detection (Warmth and Heat Pain) Heat Pain Threshold	39.8 Degrees celsius Standard Deviation 2.401845207	40.0 Degrees celsius Standard Deviation 2.2098072	40.0 Degrees celsius Standard Deviation 2.80388162	39.4 Degrees celsius Standard Deviation 2.305045253	39.7 Degrees celsius Standard Deviation 2.227588606

SECONDARY outcome

Timeframe: 5 minutes

Population: All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin.

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.