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Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03997851
Recruitment Status : Completed
First Posted : June 25, 2019
Results First Posted : April 19, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Gil Yosipovitch, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pruritus
Interventions Drug: Acetaminophen
Drug: Carbomer 980
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topical Acetaminophen and Vehicle Gel
Hide Arm/Group Description

Each participant will receive topical gel treatments applied for 30 minutes to 4 separate 4 x 4 cm predefined skin areas on the ventral forearms twice at 2 separate study visits.

The 4 treatments are:

5% acetaminophen gel 2.5% acetaminophen gel

1% acetaminophen gel Vehicle gel

Acetaminophen: Topical acetaminophen gel

Period Title: Overall Study
Number of participants Number of units (4x4cm skin arm test area)
Started 17 136
Completed 17 136
Not Completed 0 0
Arm/Group Title Topical Acetaminophen and Vehicle Gel
Hide Arm/Group Description

Each participant will receive topical gel treatments applied for 30 minutes to 4 separate 4 x 4 cm predefined skin areas on the ventral forearms twice at 2 separate study visits.

The 4 treatments are:

5% acetaminophen gel 2.5% acetaminophen gel

1% acetaminophen gel Vehicle gel

Acetaminophen: Topical acetaminophen gel

Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
Each participant will receive 4 topical gel treatments twice at 2 separate study visits. The 4 treatments are: 5% acetaminophen gel 2.5% acetaminophen gel 1% acetaminophen gel Vehicle gel Acetaminophen: Topical acetaminophen gel
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
15
  88.2%
Male
2
  11.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Hispanic or Latino
5
  29.4%
Not Hispanic or Latino
12
  70.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
  17.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  17.6%
White
11
  64.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Peak Itch Intensity Between the Vehicle and Active Treatments During Non-histaminergic Itch Induction
Hide Description Peak itch intensity between the vehicle and 3 other active treatments (5%, 2.5%, and 1% acetaminophen gels) after non-histaminergic itch induction (cowhage). Itch intensity was measured on a 10cm scale visual analog scale for 10 minutes. 0 was weighted with "no itch" and 10 was weighted with "most itch imaginable".
Time Frame 10 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects received 4 topical cream treatments.
Arm/Group Title Topical 5% Acetaminophen Gel Topical 2.5% Acetaminophen Gel Topical 1% Acetaminophen Gel Topical Vehicle Gel
Hide Arm/Group Description:

Topical 5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical 2.5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical 1% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical vehile gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Carbomer 980: Topical vehicle gel

Overall Number of Participants Analyzed 17 17 17 17
Mean (Standard Deviation)
Unit of Measure: Intensity score
4.5  (1.98) 3.94  (2.77) 5.32  (2.29) 5.79  (2.61)
2.Primary Outcome
Title Peak Itch Intensity Between the Vehicle and Active Treatments During Histaminergic Itch Induction
Hide Description Peak itch intensity between the vehicle and 3 other active treatments (5%, 2.5%, and 1% acetaminophen gels) after histaminergic itch induction. Itch intensity was measured on a 10cm scale visual analog scale for 10 minutes. 0 was weighted with "no itch" and 10 was weighted with "most itch imaginable".
Time Frame 10 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects received 4 topical cream treatments.
Arm/Group Title Topical 5% Acetaminophen Gel Topical 2.5% Acetaminophen Gel Topical 1% Acetaminophen Gel Topical Vehicle Gel
Hide Arm/Group Description:

Topical 5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical 2.5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical 1% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical vehile gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Carbomer 980: Topical vehicle gel

Overall Number of Participants Analyzed 17 17 17 17
Mean (Standard Deviation)
Unit of Measure: Intensity score
2.04  (2.52) 2.38  (2.26) 2.91  (2.31) 3.07  (2.64)
3.Secondary Outcome
Title Thermal Threshold Detection (Heat Pain)
Hide Description Standardized quantitative sensory testing is performed to measure heat pain threshold (assesses the threshold at which heat pain sensation is first detected). Measured in Celsius.
Time Frame 3 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects received treatment with the 4 topical cream formulations at 2 study visits. Quantitative sensory testing was performed on each area of treated skin.
Arm/Group Title Topical 5% Acetaminophen Gel Topical 2.5% Acetaminophen Gel Topical 1% Acetaminophen Gel Topical Vehicle Gel
Hide Arm/Group Description:

Topical 5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical 2.5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical 1% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical vehile gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Carbomer 980: Topical vehicle gel

Overall Number of Participants Analyzed 17 17 17 17
Mean (Standard Deviation)
Unit of Measure: Degrees celsius
After histamine itch induction 43.95  (2.17) 44.51  (0.72) 43.94  (0.88) 44.07  (0.56)
After non-histamine itch induction 43.99  (0.95) 44.03  (0.81) 44.30  (0.64) 44.20  (0.59)
Time Frame Up to 2 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topical 5% Acetaminophen Gel Topical 2.5% Acetaminophen Gel Topical 1% Acetaminophen Gel Topical Vehicle Gel
Hide Arm/Group Description

Topical 5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical 2.5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical 1% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel

Topical vehile gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Carbomer 980: Topical vehicle gel

All-Cause Mortality
Topical 5% Acetaminophen Gel Topical 2.5% Acetaminophen Gel Topical 1% Acetaminophen Gel Topical Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Hide Serious Adverse Events
Topical 5% Acetaminophen Gel Topical 2.5% Acetaminophen Gel Topical 1% Acetaminophen Gel Topical Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Topical 5% Acetaminophen Gel Topical 2.5% Acetaminophen Gel Topical 1% Acetaminophen Gel Topical Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Leigh Nattkemper
Organization: University of Miami
Phone: 3055889734
EMail: Lxn202@med.miami.edu
Layout table for additonal information
Responsible Party: Gil Yosipovitch, University of Miami
ClinicalTrials.gov Identifier: NCT03997851    
Other Study ID Numbers: 20190133
First Submitted: June 24, 2019
First Posted: June 25, 2019
Results First Submitted: March 22, 2021
Results First Posted: April 19, 2021
Last Update Posted: April 19, 2021