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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 : Recruiting
First Posted : June 25, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Gil Yosipovitch, University of Miami

Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date August 5, 2019
Actual Study Start Date  ICMJE July 22, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Peak itch intensity between the vehicle and active treatments during non-histaminergic itch induction [ Time Frame: 10 minutes ]
    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 100mm scale visual analog scale for 10 minutes. 0 was weighted with "no itch" and 100 was weighted with "most itch imaginable".
  • Peak itch intensity between the vehicle and active treatments during histaminergic itch induction [ Time Frame: 10 minutes ]
    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 100mm scale visual analog scale for 10 minutes. 0 was weighted with "no itch" and 100 was weighted with "most itch imaginable".
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03997851 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
Thermal threshold detection (heat pain) [ Time Frame: 3 minutes ]
Standardized quantitative sensory testing is performed to measure heat pain threshold (assesses the threshold at which heat pain sensation is first detected). Measured in change in Celsius.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects
Official Title  ICMJE Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects
Brief Summary Currently, topical antihistamines and corticosteroids are mainly used for itching relief. However, the over the counter antihistamines are not effective on all itch conditions. Acetaminophen is a popular and widely used OTC drug for pain relief. Although its mode of action is still unknown, recent studies have shown that acetaminophen indirectly activates cannabinoid CB1 receptors. Recent studies have shown that topical cannabinoid agonists are effective for itch relief, the efficacy of topical acetaminophen will be tested for non-histaminergic itch relief.
Detailed Description This will be a single-blinded, vehicle-controlled randomized study in healthy controls to test the efficacy of the topical gel formulation with three differing concentrations of acetaminophen (APAP) for itch relief. To detect medium effects of the treatments with a given α of 0.5 and an error probability of 0.05, with a power of 0.95, the number of participants needed is 36 (10 within post hoc pairwise comparisons).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
The antipruritic effect of 3 topical treatments of varying doses and 1 vehicle treatment will be explored in each subject. One study visit will consist of testing all topical formulations on histaminergic induced itch, and second study visit will test all topical formulations on non-histaminergic induced itch.
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Pruritus
Intervention  ICMJE
  • Drug: Acetaminophen
    Topical acetaminophen gel
    Other Name: Topical acetaminophen gel
  • Drug: Carbomer 980
    Topical vehicle gel
    Other Name: Topical vehicle gel
Study Arms  ICMJE
  • Experimental: Topical 5% acetaminophen gel
    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.
    Intervention: Drug: Acetaminophen
  • Experimental: Topical 2.5% 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.
    Intervention: Drug: Acetaminophen
  • Experimental: Topical 1% 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.
    Intervention: Drug: Acetaminophen
  • Placebo Comparator: Topical vehicle 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.
    Intervention: Drug: Carbomer 980
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy subjects must be 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 from the week prior to the study till the completion of the study.
  5. Must abstain from the use of moisturizers on the arms 24 hours before study visits.

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.
  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 in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
  7. Use of emollients on the arms a week prior to the study and throughout the study.
  8. Known allergies to acetaminophen and cowhage.
  9. Pregnant women. (Women of child bearing potential will undergo an hCG pregnancy test).
  10. Currently incarcerated.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Leigh A Nattkemper, PhD 305-588-9734 lxn202@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03997851
Other Study ID Numbers  ICMJE 20190133
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gil Yosipovitch, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gil Yosipovitch, MD University of Miami
PRS Account University of Miami
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP