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Topical Aprepitant in Prurigo Patients (iTAPP)

Primary Purpose

Pruritus

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Aprepitant

Placebo

About this trial

This is an interventional treatment trial for Pruritus focused on measuring Pruritus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

placebo (left) / aprepitant (right)

aprepitant (left) / placebo (right)

Arm Description

placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body)

aprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

Non-lesional Erythema by Mexameter

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.

Non-lesional Melanin by Mexameter

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.

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.

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.

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.

Full Information

NCT ID

NCT01963793

First Posted

September 18, 2013

Last Updated

June 28, 2021

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01963793

Brief Title

Topical Aprepitant in Prurigo Patients

Acronym

iTAPP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

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

Pruritus

Keywords

Pruritus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo (left) / aprepitant (right)

Arm Type

Other

Arm Description

placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body)

Arm Title

aprepitant (left) / placebo (right)

Arm Type

Other

Arm Description

aprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body)

Intervention Type

Drug

Intervention Name(s)

Aprepitant

Other Intervention Name(s)

Aprepitant gel

Intervention Description

Aprepitant gel (10 mg/g)

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

aprepitant gel vehicle

Intervention Description

gel without active component

Primary Outcome Measure Information:

Title

Pruritus by VAS (Visual Analogue Scale)

Description

Time Frame

At end of treatment (Day 28)

Secondary Outcome Measure Information:

Title

Pruritus by VAS (Visual Analogue Scale)

Description

Time Frame

At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42

Title

Change From Baseline in Participants' Global Assessment on Treatment Areas

Description

Time Frame