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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 : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Gil Yosipovitch, University of Miami

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.

Condition or disease Intervention/treatment Phase
Pruritus Drug: Acetaminophen Drug: Carbomer 980 Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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
Official Title: Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
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.
Drug: Acetaminophen
Topical acetaminophen gel
Other Name: Topical acetaminophen gel

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.
Drug: Acetaminophen
Topical acetaminophen gel
Other Name: Topical acetaminophen gel

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.
Drug: Acetaminophen
Topical acetaminophen gel
Other Name: Topical acetaminophen gel

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.
Drug: Carbomer 980
Topical vehicle gel
Other Name: Topical vehicle gel




Primary Outcome Measures :
  1. 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".

  2. 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".


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997851


Contacts
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Contact: Leigh A Nattkemper, PhD 305-588-9734 lxn202@med.miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Leigh A Nattkemper, PhD    305-588-9734    lxn202@med.miami.edu   
Principal Investigator: Gil Yosipovitch, MD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Gil Yosipovitch, MD University of Miami

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Responsible Party: Gil Yosipovitch, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03997851     History of Changes
Other Study ID Numbers: 20190133
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Acetaminophen
Diphenhydramine
Promethazine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Antipruritics
Dermatologic Agents