Topical Aprepitant in Prurigo Patients

Study Overview
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Brief Summary
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Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo

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

Conditions
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Pruritus

Intervention / Treatment
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* Drug: Aprepitant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: placebo (left) / aprepitant (right)<br>placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body) | Drug: Aprepitant<br>* Aprepitant gel (10 mg/g)<br>* Other names: Aprepitant gel;Drug: Placebo<br>* gel without active component<br>* Other names: aprepitant gel vehicle;|
| Other: aprepitant (left) / placebo (right)<br>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<br>* Aprepitant gel (10 mg/g)<br>* Other names: Aprepitant gel;Drug: Placebo<br>* gel without active component<br>* Other names: aprepitant gel vehicle;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pruritus