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Influence of Antipruritics on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin.

Primary Purpose

Pruritus

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Desloratadine 5 mg
Aprepitant 125 mg
Ketotifen 1 MG
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pruritus

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is a white male ≥ 18 and ≤ 45 years of age at the time of screening
  • Subject is a nonsmoker for at least 6 months prior to the study start
  • Subject has a body mass index ≥ 18 and ≤ 30 kg/m2
  • Subject has a clear increase in histamine-induced dermal blood flow; Subject has an increase in capsaicin- and cinnamaldehyde-induced dermal blood flow of at least 100% as determined during the screening visit
  • Subject is judged to be in good health on the basis of medical history, physical examination and vital signs
  • Subject understands the procedures and agrees to comply with them for the entire length of the study by giving written informed consent.

Exclusion Criteria:

  • Subject has excessive hair growth on the volar surface of the forearm
  • Subject has a past or present history of diffuse dermatological conditions including eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis
  • Subject has any abnormality on the skin of the forearm, possibly interfering with the study assessments including tattoos, keloids, tumors, ulcers, burns, flaps and grafts;
  • Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover the forearms 24 hours before and after each study visit
  • Subject currently uses lotions, oils, depilatory preparations, makeup or other topical treatments on the arms and on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study
  • Subject has a past or present history of (symptomatic) asthma
  • Subject has a history of severe allergic reactions to food or drugs or adverse experiences of a serious nature related to the administration of either a marketed or investigational drug, including histamine, cinnamaldehyde, capsaicin, desloratadine, ketotifen or aprepitant
  • Subject currently uses any prescription or nonprescription drugs on a regular basis which cannot be discontinued for the duration of the study; subject has used any prescription or nonprescription medication within 14 days of the start of the study
  • Subject is a habitual and heavy consumer of coffee or caffeinated beverages (more than approximately 4 cups of tea, coffee or cola per day) at the time of the study. Subjects who have reduced their consumption to ≤ 4 cups per day at least 1 week prior to enrollment may participate; Subjects who cannot refrain from caffeinated beverages 24 hours before the study visit
  • Subject is unable to refrain from drinking alcohol 24 hours prior to histamine application, is currently a regular user (including "recreational use") of any illicit drugs, or has a history of drug (including alcohol) abuse. A drug screen will include amphetamines/ methamphetamines, methylenedioxymethamphetamine, benzodiazepines, barbiturates, cocaine, cannabis, tricyclic antidepressants, methadone and opiates
  • Subject cannot refrain from being around second hand smoke 24 hours prior to histamine application or uses nicotine-containing products. Ex-smokers should have ceased smoking at least 6 months prior to screening
  • Subject has any of the following vital sign measurements at screening: heart rate ≤ 40 or ≥ 100 beats/min, diastolic blood pressure ≤ 50 or ≥ 89 mmHg and/or systolic Blood Pressure ≤ 90 or ≥ 139 mmHg
  • Subject has been involved in testing an investigational drug in another clinical study within the last 4 weeks or 5 half-lives
  • Subject has evidence of a clinically significant active infection, fever of 38°C or above at the time of the study visits
  • Subject has a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs
  • Subject is in a situation or has a condition, which, in the opinion of the investigator, may interfere with safe and optimal participation in the study
  • Subject has a history of any illness or disorder, which, in the opinion of the investigator, might confound the results of the study.

Sites / Locations

  • Center for Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Arm Description

Desloratadine - Aprepitant - Ketotifen

Aprepitant - Ketotifen - Desloratadine

Ketotifen - Desloratadine - Aprepitant

Outcomes

Primary Outcome Measures

Change in dermal blood flow induced by histamine skin pricks, compared to baseline and placebo following the administration of different antipruritic drugs

Secondary Outcome Measures

Change in dermal blood flow induced by topical application of cinnamaldehyde and capsaicin, compared to baseline and placebo following the administration of different antipruritic drugs

Full Information

First Posted
May 18, 2020
Last Updated
May 25, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04399148
Brief Title
Influence of Antipruritics on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin.
Official Title
Influence of Antipruritics on the Dermal Blood Flow Response After a Histamine Skin Prick as Well as After the Topical Application of Cinnamaldehyde and Capsaicin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
September 23, 2019 (Actual)
Study Completion Date
September 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In order to validate the accuracy and reliability of the histamine skin prick model for histaminergic itch and vasodilation, the dermal blood flow response induced by a histamine skin prick will be evaluated after the administration of certain antipruritics. Besides, the influence of these antipruritics on the dermal blood flow response induced by the topical application of cinnamaldehyde and capsaicin will be evaluated. Changes in dermal blood flow will be measured with laser speckle contrast imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blind, cross-over study
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Desloratadine - Aprepitant - Ketotifen
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Aprepitant - Ketotifen - Desloratadine
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Ketotifen - Desloratadine - Aprepitant
Intervention Type
Drug
Intervention Name(s)
Desloratadine 5 mg
Intervention Description
Desloratadine (H1-antihistamine): oral tablet (1 x 5 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick
Intervention Type
Drug
Intervention Name(s)
Aprepitant 125 mg
Intervention Description
Aprepitant (NK1-antagonist): hard capsule (1 x 125 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick
Intervention Type
Drug
Intervention Name(s)
Ketotifen 1 MG
Intervention Description
Ketotifen (H1-antihistamine and mast cell stabilizer): capsule (1 x 1 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick
Primary Outcome Measure Information:
Title
Change in dermal blood flow induced by histamine skin pricks, compared to baseline and placebo following the administration of different antipruritic drugs
Time Frame
The dermal blood flow will be assessed before (baseline) and every 10 minutes during the hour following the skin pricks
Secondary Outcome Measure Information:
Title
Change in dermal blood flow induced by topical application of cinnamaldehyde and capsaicin, compared to baseline and placebo following the administration of different antipruritic drugs
Time Frame
The dermal blood flow will be assessed before (baseline) and every 10 minutes during the hour following application

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is a white male ≥ 18 and ≤ 45 years of age at the time of screening Subject is a nonsmoker for at least 6 months prior to the study start Subject has a body mass index ≥ 18 and ≤ 30 kg/m2 Subject has a clear increase in histamine-induced dermal blood flow; Subject has an increase in capsaicin- and cinnamaldehyde-induced dermal blood flow of at least 100% as determined during the screening visit Subject is judged to be in good health on the basis of medical history, physical examination and vital signs Subject understands the procedures and agrees to comply with them for the entire length of the study by giving written informed consent. Exclusion Criteria: Subject has excessive hair growth on the volar surface of the forearm Subject has a past or present history of diffuse dermatological conditions including eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis Subject has any abnormality on the skin of the forearm, possibly interfering with the study assessments including tattoos, keloids, tumors, ulcers, burns, flaps and grafts; Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover the forearms 24 hours before and after each study visit Subject currently uses lotions, oils, depilatory preparations, makeup or other topical treatments on the arms and on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study Subject has a past or present history of (symptomatic) asthma Subject has a history of severe allergic reactions to food or drugs or adverse experiences of a serious nature related to the administration of either a marketed or investigational drug, including histamine, cinnamaldehyde, capsaicin, desloratadine, ketotifen or aprepitant Subject currently uses any prescription or nonprescription drugs on a regular basis which cannot be discontinued for the duration of the study; subject has used any prescription or nonprescription medication within 14 days of the start of the study Subject is a habitual and heavy consumer of coffee or caffeinated beverages (more than approximately 4 cups of tea, coffee or cola per day) at the time of the study. Subjects who have reduced their consumption to ≤ 4 cups per day at least 1 week prior to enrollment may participate; Subjects who cannot refrain from caffeinated beverages 24 hours before the study visit Subject is unable to refrain from drinking alcohol 24 hours prior to histamine application, is currently a regular user (including "recreational use") of any illicit drugs, or has a history of drug (including alcohol) abuse. A drug screen will include amphetamines/ methamphetamines, methylenedioxymethamphetamine, benzodiazepines, barbiturates, cocaine, cannabis, tricyclic antidepressants, methadone and opiates Subject cannot refrain from being around second hand smoke 24 hours prior to histamine application or uses nicotine-containing products. Ex-smokers should have ceased smoking at least 6 months prior to screening Subject has any of the following vital sign measurements at screening: heart rate ≤ 40 or ≥ 100 beats/min, diastolic blood pressure ≤ 50 or ≥ 89 mmHg and/or systolic Blood Pressure ≤ 90 or ≥ 139 mmHg Subject has been involved in testing an investigational drug in another clinical study within the last 4 weeks or 5 half-lives Subject has evidence of a clinically significant active infection, fever of 38°C or above at the time of the study visits Subject has a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs Subject is in a situation or has a condition, which, in the opinion of the investigator, may interfere with safe and optimal participation in the study Subject has a history of any illness or disorder, which, in the opinion of the investigator, might confound the results of the study.
Facility Information:
Facility Name
Center for Clinical Pharmacology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

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Influence of Antipruritics on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin.

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