Topical Aprepitant in Prurigo Patients (iTAPP)

Topical Aprepitant in Prurigo Patients An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo

Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo

Study Overview

• Status: Completed
• Conditions: Pruritus
• Intervention / Treatment: Drug: Aprepitant; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, D-10117
    • Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with Prurigo suffering from chronic pruritus
• Disease duration > six month
• Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressants, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation
• Adult male or female patients, aged 18 to 80 years

Exclusion Criteria:

• Concomitant medications that are primarily metabolized through Cytochrome P450 3A4
• Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial
• UV-irradiation during the last 6 weeks prior to Visit 1 (Screening)
• Prescribed systemic medications are limited
• Clinically significant abnormalities in Blood analyses
• Anamnestic excessive use of alcohol or tobacco or drugs
• Presence of active tumor disease or history of malignancies within five years prior to Visit 1 (Screening)
• Known or suspected hypersensitivity to component(s) of investigational products
• Within the last 30 days or current participation in any other interventional clinical trial
• Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 6 month
• Previously enrolled/randomised in this clinical trial
• In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)
• Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding
• Females of child-bearing potential with positive pregnancy test
• Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: placebo (left) / aprepitant (right); placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body)	Drug: Aprepitant; Aprepitant gel (10 mg/g); Other Names: Aprepitant gel; Drug: Placebo; gel without active component; Other Names: aprepitant gel vehicle
Other: aprepitant (left) / placebo (right); aprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body)	Drug: Aprepitant; Aprepitant gel (10 mg/g); Other Names: Aprepitant gel; Drug: Placebo; gel without active component; Other Names: aprepitant gel vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus by VAS (Visual Analogue Scale)	At end of treatment (Day 28) participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.	At end of treatment (Day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus by VAS (Visual Analogue Scale)	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.	At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42
Change From Baseline in Participants' Global Assessment on Treatment Areas	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed their prurigo on each treated area using the following score: 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. The change was calculated as the value at the later time point minus the value at baseline. The change at Day 1 was therefore 0 and negative values represent a decrease in score.	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Crusting	The (sub)investigator assessed the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Crusts Evaluation: 0 = not existing; = mild; = moderate; = severe The score will be an integer on the scale 0-3.	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Erythema	The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Erythema Evaluation: 0 = not existing; = mild; = moderate; = severe The score will be an integer on the scale 0-3.	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Scratch Artefacts	The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Scratch artefacts: Superficial damage to the skin caused by severe scratching. Evaluation: 0 = not existing; = mild; = moderate; = severe The score will be an integer on the scale 0-3.	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Infiltration	The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Infiltration Evaluation: 0 = not existing; = mild; = moderate; = severe The score will be an integer on the scale 0-3.	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Transepidermal Water Loss (TEWL)	The (sub)investigator will made the following clinical assessment: Transepidermal water loss was defined as amount of released water from skin surface in g/cm^2 per hour. The TEWL is increased in case of damage of skin barrier.	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Lesional Erythema by Mexameter	The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Non-lesional Erythema by Mexameter	The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Melanin by Mexameter	The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Non-lesional Melanin by Mexameter	The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)	During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the number of hours with pruritus within the last 12 hours on both areas by use of a 7-point scale (<0.5 hours, 0.5-1 hours, 1-2 hours, 3-4 hours, 5-6 hours, 7-8 hours, 9-12 hours). Duration of pruritus was categorized as follows: 1 if <0.5 hours, 2 if 0.5-1 hours, 3 if 1-2 hours, 4 if 3-4 hours, 5 if 5-6 hours, 6 if 7-8 hours and 7 if 9-12 hours. The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.	From baseline to Day 31
Daily Assessments of Average Pruritus by Use of a VAS	During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the average intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line. The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1, before cream was applied.	From baseline to Day 31
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS	During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the maximum intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line. The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.	From baseline to Day 31
Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment	On the last day of treatment, participants assessed the change of pruritus compared to baseline in percentage by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.	Day 28

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Maurer (ICI) Marcus, Prof. Dr. med., Allergie-Centrum-Charité, Charité Universitätsmedizin Berlin, Charitéplatz1, D-10117 Berlin

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: September 18, 2013
• First Submitted That Met QC Criteria: October 11, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus; Prurigo; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Neurokinin-1 Receptor Antagonists; Aprepitant; Fosaprepitant
• Other Study ID Numbers: LP0066-1019