Pruritus
Conditions
Keywords
Pruritus
Brief summary
Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
Interventions
DRUGAprepitant
Aprepitant gel (10 mg/g)
DRUGPlacebo
gel without active component
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pruritus by VAS (Visual Analogue Scale) | At end of treatment (Day 28) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Participants' Global Assessment on Treatment Areas | At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 | 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 | At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 | 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 1. = mild 2. = moderate 3. = severe The score will be an integer on the scale 0-3. |
| Clinical Score Assessment of Erythema | At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 | 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 1. = mild 2. = moderate 3. = severe The score will be an integer on the scale 0-3. |
| Clinical Score Assessment of Scratch Artefacts | At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 | 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 1. = mild 2. = moderate 3. = severe The score will be an integer on the scale 0-3. |
| Clinical Score Assessment of Infiltration | At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 | 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 1. = mild 2. = moderate 3. = severe The score will be an integer on the scale 0-3. |
| Transepidermal Water Loss (TEWL) | At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 | 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 | At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 | 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. |
| Pruritus by VAS (Visual Analogue Scale) | At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42 | 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. |
| Melanin by Mexameter | At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 | 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 | At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 | 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. |
| Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | From baseline to Day 31 | 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 | From baseline to Day 31 | 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 | From baseline to Day 31 | 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 | Day 28 | 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. |
| Non-lesional Erythema by Mexameter | At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aprepitant Gel / Aprepitant Gel Vehicle All 20 randomised participants were divided into two groups 1:1 10 with LEFT: aprepitant 10 mg/g gel and RIGHT: vehicle gel and 10 with LEFT: vehicle gel and RIGHT: aprepitant 10 mg/g gel | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Aprepitant Gel / Aprepitant Gel Vehicle |
|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment Germany | 20 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 10 / 20 | 15 / 20 | 11 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: At end of treatment (Day 28)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Aprepitant 10 mg/g Gel | Pruritus by VAS (Visual Analogue Scale) | 19.7 mm |
| Aprepitant Gel Vehicle | Pruritus by VAS (Visual Analogue Scale) | 21.2 mm |
p-value: 0.5895% CI: [-7.12, 4.11]t-test, 2 sided
Secondary
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Change From Baseline in Participants' Global Assessment on Treatment Areas | Day 1 (Visit 2) | 0.0 units on a scale | Standard Deviation 0 |
| Aprepitant 10 mg/g Gel | Change From Baseline in Participants' Global Assessment on Treatment Areas | Day 14 (Visit 3) | -0.5 units on a scale | Standard Deviation 0.8 |
| Aprepitant 10 mg/g Gel | Change From Baseline in Participants' Global Assessment on Treatment Areas | Day 28 (Visit 4) | -0.6 units on a scale | Standard Deviation 1.1 |
| Aprepitant 10 mg/g Gel | Change From Baseline in Participants' Global Assessment on Treatment Areas | Day 42 (Visit 5) | -0.3 units on a scale | Standard Deviation 0.9 |
| Aprepitant Gel Vehicle | Change From Baseline in Participants' Global Assessment on Treatment Areas | Day 42 (Visit 5) | -0.4 units on a scale | Standard Deviation 0.9 |
| Aprepitant Gel Vehicle | Change From Baseline in Participants' Global Assessment on Treatment Areas | Day 1 (Visit 2) | 0.0 units on a scale | Standard Deviation 0 |
| Aprepitant Gel Vehicle | Change From Baseline in Participants' Global Assessment on Treatment Areas | Day 28 (Visit 4) | -0.7 units on a scale | Standard Deviation 1.1 |
| Aprepitant Gel Vehicle | Change From Baseline in Participants' Global Assessment on Treatment Areas | Day 14 (Visit 3) | -0.7 units on a scale | Standard Deviation 0.9 |
Secondary
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 1. = mild 2. = moderate 3. = severe The score will be an integer on the scale 0-3.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Crusting | Day 1 (Visit 2) | 1.3 units on a scale | Standard Deviation 0.9 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Crusting | Day 14 (Visit 3) | 0.9 units on a scale | Standard Deviation 0.9 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Crusting | Day 28 (Visit 4) | 0.7 units on a scale | Standard Deviation 0.8 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Crusting | Day 42 (Visit 5) | 0.8 units on a scale | Standard Deviation 0.8 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Crusting | Day 42 (Visit 5) | 0.9 units on a scale | Standard Deviation 0.7 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Crusting | Day 1 (Visit 2) | 1.4 units on a scale | Standard Deviation 0.9 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Crusting | Day 28 (Visit 4) | 1.0 units on a scale | Standard Deviation 1.1 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Crusting | Day 14 (Visit 3) | 1.1 units on a scale | Standard Deviation 0.8 |
Secondary
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 1. = mild 2. = moderate 3. = severe The score will be an integer on the scale 0-3.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Erythema | Day 1 (Visit 2) | 2.0 units on a scale | Standard Deviation 0.8 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Erythema | Day 14 (Visit 3) | 1.8 units on a scale | Standard Deviation 0.9 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Erythema | Day 28 (Visit 4) | 1.5 units on a scale | Standard Deviation 0.9 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Erythema | Day 42 (Visit 5) | 1.5 units on a scale | Standard Deviation 0.8 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Erythema | Day 42 (Visit 5) | 1.6 units on a scale | Standard Deviation 0.7 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Erythema | Day 1 (Visit 2) | 2.1 units on a scale | Standard Deviation 0.8 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Erythema | Day 28 (Visit 4) | 1.7 units on a scale | Standard Deviation 0.9 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Erythema | Day 14 (Visit 3) | 1.8 units on a scale | Standard Deviation 0.9 |
Secondary
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 1. = mild 2. = moderate 3. = severe The score will be an integer on the scale 0-3.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Infiltration | Day 1 (Visit 2) | 1.5 units on a scale | Standard Deviation 1.2 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Infiltration | Day 14 (Visit 3) | 1.3 units on a scale | Standard Deviation 1 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Infiltration | Day 28 (Visit 4) | 1.1 units on a scale | Standard Deviation 0.9 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Infiltration | Day 42 (Visit 5) | 1.3 units on a scale | Standard Deviation 0.9 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Infiltration | Day 42 (Visit 5) | 1.5 units on a scale | Standard Deviation 1.1 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Infiltration | Day 1 (Visit 2) | 1.5 units on a scale | Standard Deviation 1.1 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Infiltration | Day 28 (Visit 4) | 1.3 units on a scale | Standard Deviation 1 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Infiltration | Day 14 (Visit 3) | 1.4 units on a scale | Standard Deviation 1.1 |
Secondary
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 1. = mild 2. = moderate 3. = severe The score will be an integer on the scale 0-3.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Scratch Artefacts | Day 1 (Visit 2) | 1.7 units on a scale | Standard Deviation 1.1 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Scratch Artefacts | Day 14 (Visit 3) | 1.3 units on a scale | Standard Deviation 1.1 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Scratch Artefacts | Day 28 (Visit 4) | 1.1 units on a scale | Standard Deviation 1 |
| Aprepitant 10 mg/g Gel | Clinical Score Assessment of Scratch Artefacts | Day 42 (Visit 5) | 1.4 units on a scale | Standard Deviation 1.2 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Scratch Artefacts | Day 42 (Visit 5) | 1.4 units on a scale | Standard Deviation 1.2 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Scratch Artefacts | Day 1 (Visit 2) | 1.8 units on a scale | Standard Deviation 1.1 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Scratch Artefacts | Day 28 (Visit 4) | 1.4 units on a scale | Standard Deviation 1.1 |
| Aprepitant Gel Vehicle | Clinical Score Assessment of Scratch Artefacts | Day 14 (Visit 3) | 1.3 units on a scale | Standard Deviation 1.1 |
Secondary
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.
Time frame: From baseline to Day 31
Population: Results were collected from a diary that participants were requested to fill in twice a day. Some participants missed some of the entries so there are less than 20 participants analysed for some of the time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 8 | 23.3 mm | Standard Deviation 12.6 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 1 | 45.0 mm | Standard Deviation 21.5 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 2 | 35.1 mm | Standard Deviation 24.1 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 3 | 33.7 mm | Standard Deviation 21 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 4 | 31.8 mm | Standard Deviation 20.2 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 5 | 27.4 mm | Standard Deviation 19.6 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 6 | 26.4 mm | Standard Deviation 15.9 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 7 | 30.4 mm | Standard Deviation 21.7 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day -1 | 49.1 mm | Standard Deviation 20.9 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 9 | 24.5 mm | Standard Deviation 16.6 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 10 | 22.0 mm | Standard Deviation 14.8 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 11 | 23.3 mm | Standard Deviation 18.8 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 12 | 19.9 mm | Standard Deviation 13.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 13 | 21.8 mm | Standard Deviation 26 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 14 | 20.9 mm | Standard Deviation 15.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 15 | 24.2 mm | Standard Deviation 16.9 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 16 | 20.8 mm | Standard Deviation 13.6 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 17 | 20.2 mm | Standard Deviation 14.6 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 18 | 18.5 mm | Standard Deviation 13.6 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 19 | 15.6 mm | Standard Deviation 11.2 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 20 | 16.0 mm | Standard Deviation 11.9 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 21 | 14.5 mm | Standard Deviation 14.6 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 22 | 14.3 mm | Standard Deviation 13.2 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 23 | 15.6 mm | Standard Deviation 13.6 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 24 | 15.7 mm | Standard Deviation 14.1 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 25 | 18.2 mm | Standard Deviation 16.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 26 | 15.1 mm | Standard Deviation 13.1 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 27 | 14.2 mm | Standard Deviation 15.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 28 | 7.8 mm | Standard Deviation 7.5 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 29 | 3.0 mm | Standard Deviation 2.8 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 30 | 3.0 mm | — |
| Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 31 | NA mm | — |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 23 | 17.2 mm | Standard Deviation 14.3 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 16 | 24.3 mm | Standard Deviation 16.7 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 5 | 31.0 mm | Standard Deviation 18 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 22 | 15.9 mm | Standard Deviation 15.1 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 28 | 11.6 mm | Standard Deviation 10.6 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 17 | 21.7 mm | Standard Deviation 14.8 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 25 | 16.8 mm | Standard Deviation 14 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 21 | 17.0 mm | Standard Deviation 16.4 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 11 | 28.4 mm | Standard Deviation 19.1 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 18 | 21.1 mm | Standard Deviation 14.5 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 9 | 27.6 mm | Standard Deviation 17.9 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 29 | 5.5 mm | Standard Deviation 2.1 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 20 | 19.7 mm | Standard Deviation 12.9 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 19 | 19.9 mm | Standard Deviation 16 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 4 | 37.5 mm | Standard Deviation 18.3 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 31 | NA mm | — |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 30 | 3.0 mm | — |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 12 | 23.7 mm | Standard Deviation 12.6 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 8 | 28.8 mm | Standard Deviation 16.1 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 3 | 35.8 mm | Standard Deviation 20.4 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 27 | 14.1 mm | Standard Deviation 12.9 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 13 | 26.4 mm | Standard Deviation 14.8 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 6 | 31.5 mm | Standard Deviation 17.6 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 2 | 38.9 mm | Standard Deviation 22.2 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 7 | 33.2 mm | Standard Deviation 22.2 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 14 | 23.1 mm | Standard Deviation 13.7 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 10 | 28.2 mm | Standard Deviation 17.7 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 1 | 44.7 mm | Standard Deviation 21.7 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 24 | 16.7 mm | Standard Deviation 15.1 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 15 | 25.2 mm | Standard Deviation 16 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 26 | 16.6 mm | Standard Deviation 15.8 |
| Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day -1 | 51.3 mm | Standard Deviation 21.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 30 | 3.5 mm | Standard Deviation 2.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 8 | 26.5 mm | Standard Deviation 18.4 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 9 | 26.8 mm | Standard Deviation 17.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 26 | 19.8 mm | Standard Deviation 17.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 10 | 30.6 mm | Standard Deviation 21.6 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 11 | 22.3 mm | Standard Deviation 15.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 12 | 23.0 mm | Standard Deviation 17 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 13 | 20.2 mm | Standard Deviation 13.4 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 27 | 13.6 mm | Standard Deviation 13.8 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 14 | 21.9 mm | Standard Deviation 15.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 15 | 19.3 mm | Standard Deviation 14.6 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 16 | 22.7 mm | Standard Deviation 15.4 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 17 | 18.8 mm | Standard Deviation 14.4 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 28 | 16.4 mm | Standard Deviation 14.5 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 18 | 21.6 mm | Standard Deviation 13.9 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 19 | 20.7 mm | Standard Deviation 14.9 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 20 | 17.8 mm | Standard Deviation 13.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 21 | 16.1 mm | Standard Deviation 13.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 29 | 4.7 mm | Standard Deviation 6.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 22 | 15.3 mm | Standard Deviation 14.4 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 23 | 15.8 mm | Standard Deviation 16 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 31 | 2.0 mm | — |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day -1 | NA mm | — |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 1 | 46.9 mm | Standard Deviation 21.6 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 24 | 16.5 mm | Standard Deviation 16.6 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 2 | 38.3 mm | Standard Deviation 18.4 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 3 | 33.6 mm | Standard Deviation 21 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 4 | 34.5 mm | Standard Deviation 22.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 5 | 24.2 mm | Standard Deviation 16.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 25 | 15.8 mm | Standard Deviation 14.8 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 6 | 26.8 mm | Standard Deviation 17.4 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Average Pruritus by Use of a VAS | Day 7 | 28.3 mm | Standard Deviation 20.9 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 10 | 30.2 mm | Standard Deviation 20.6 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 15 | 22.1 mm | Standard Deviation 13 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 25 | 16.5 mm | Standard Deviation 17 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day -1 | NA mm | — |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 27 | 14.6 mm | Standard Deviation 13 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 14 | 24.7 mm | Standard Deviation 16.1 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 5 | 33.7 mm | Standard Deviation 16.9 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 1 | 49.3 mm | Standard Deviation 20.6 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 8 | 30.1 mm | Standard Deviation 18.8 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 13 | 23.4 mm | Standard Deviation 14.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 9 | 27.4 mm | Standard Deviation 16 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 2 | 39.2 mm | Standard Deviation 19 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 24 | 15.5 mm | Standard Deviation 13.4 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 12 | 27.8 mm | Standard Deviation 16.8 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 7 | 31.9 mm | Standard Deviation 21.9 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 3 | 33.7 mm | Standard Deviation 19.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 19 | 22.4 mm | Standard Deviation 14.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 28 | 14.9 mm | Standard Deviation 13.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 30 | 3.5 mm | Standard Deviation 0.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 20 | 18.6 mm | Standard Deviation 14.9 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 18 | 22.8 mm | Standard Deviation 13 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 17 | 22.8 mm | Standard Deviation 14.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 11 | 29.3 mm | Standard Deviation 19 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 21 | 17.1 mm | Standard Deviation 12.4 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 6 | 30.3 mm | Standard Deviation 19.1 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 16 | 25.4 mm | Standard Deviation 15.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 4 | 37.2 mm | Standard Deviation 18.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 22 | 16.6 mm | Standard Deviation 12.8 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 29 | 4.9 mm | Standard Deviation 5.6 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 31 | 2.0 mm | — |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 26 | 16.3 mm | Standard Deviation 13.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Average Pruritus by Use of a VAS | Day 23 | 14.6 mm | Standard Deviation 12.7 |
Secondary
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.
Time frame: From baseline to Day 31
Population: Results were collected from a diary that participants were requested to fill in twice a day. Some participants missed some of the entries so there are less than 19 participants analysed for some of the time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 8 | 2.4 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 1 | 3.5 units on a scale | Standard Deviation 1.7 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 2 | 3.0 units on a scale | Standard Deviation 1.6 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 3 | 2.9 units on a scale | Standard Deviation 1.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 4 | 2.7 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 5 | 2.1 units on a scale | Standard Deviation 1.2 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 6 | 2.5 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 7 | 2.6 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day -1 | 3.7 units on a scale | Standard Deviation 1.9 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 9 | 2.4 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 10 | 2.4 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 11 | 2.2 units on a scale | Standard Deviation 1.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 12 | 2.1 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 13 | 2.4 units on a scale | Standard Deviation 1.6 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 14 | 2.1 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 15 | 2.4 units on a scale | Standard Deviation 1.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 16 | 2.2 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 17 | 2.2 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 18 | 2.1 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 19 | 2.1 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 20 | 2.0 units on a scale | Standard Deviation 1.2 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 21 | 2.0 units on a scale | Standard Deviation 1.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 22 | 1.9 units on a scale | Standard Deviation 1.1 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 23 | 2.3 units on a scale | Standard Deviation 1.5 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 24 | 1.9 units on a scale | Standard Deviation 1.2 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 25 | 2.3 units on a scale | Standard Deviation 1.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 26 | 2.2 units on a scale | Standard Deviation 1.2 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 27 | 2.0 units on a scale | Standard Deviation 1.2 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 28 | 1.8 units on a scale | Standard Deviation 1.2 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 29 | 1.0 units on a scale | Standard Deviation 0 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 30 | 1.0 units on a scale | — |
| Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 31 | NA units on a scale | — |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 23 | 2.4 units on a scale | Standard Deviation 1.5 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 16 | 2.4 units on a scale | Standard Deviation 1.4 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 5 | 2.7 units on a scale | Standard Deviation 1.5 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 22 | 2.3 units on a scale | Standard Deviation 1.2 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 28 | 2.3 units on a scale | Standard Deviation 1.2 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 17 | 2.5 units on a scale | Standard Deviation 1.3 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 25 | 2.5 units on a scale | Standard Deviation 1.3 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 21 | 2.2 units on a scale | Standard Deviation 1.2 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 11 | 2.8 units on a scale | Standard Deviation 1.5 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 18 | 2.3 units on a scale | Standard Deviation 1.2 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 9 | 2.8 units on a scale | Standard Deviation 1.4 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 29 | 2.0 units on a scale | Standard Deviation 0 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 20 | 2.3 units on a scale | Standard Deviation 1.2 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 19 | 2.4 units on a scale | Standard Deviation 1.3 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 4 | 3.1 units on a scale | Standard Deviation 1.4 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 31 | NA units on a scale | — |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 30 | 2.0 units on a scale | — |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 12 | 2.5 units on a scale | Standard Deviation 1.4 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 8 | 2.7 units on a scale | Standard Deviation 1.5 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 3 | 3.3 units on a scale | Standard Deviation 1.6 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 27 | 2.1 units on a scale | Standard Deviation 1.2 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 13 | 2.7 units on a scale | Standard Deviation 1.5 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 6 | 2.9 units on a scale | Standard Deviation 1.4 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 2 | 3.3 units on a scale | Standard Deviation 1.7 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 7 | 2.9 units on a scale | Standard Deviation 1.4 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 14 | 2.4 units on a scale | Standard Deviation 1.4 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 10 | 2.6 units on a scale | Standard Deviation 1.5 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 1 | 3.7 units on a scale | Standard Deviation 1.6 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 24 | 2.1 units on a scale | Standard Deviation 1.2 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 15 | 2.5 units on a scale | Standard Deviation 1.4 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 26 | 2.2 units on a scale | Standard Deviation 1.3 |
| Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day -1 | 4.0 units on a scale | Standard Deviation 2.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 30 | 1.0 units on a scale | Standard Deviation 0 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 8 | 2.3 units on a scale | Standard Deviation 1.4 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 9 | 2.4 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 26 | 2.4 units on a scale | Standard Deviation 1.5 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 10 | 2.4 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 11 | 2.0 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 12 | 2.2 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 13 | 2.2 units on a scale | Standard Deviation 1.5 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 27 | 2.1 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 14 | 2.1 units on a scale | Standard Deviation 1.4 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 15 | 2.1 units on a scale | Standard Deviation 1.5 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 16 | 2.1 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 17 | 2.1 units on a scale | Standard Deviation 1.4 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 28 | 2.0 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 18 | 2.2 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 19 | 1.9 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 20 | 2.0 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 21 | 1.9 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 29 | 1.5 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 22 | 2.0 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 23 | 2.0 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 31 | 1.0 units on a scale | — |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day -1 | NA units on a scale | — |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 1 | 3.0 units on a scale | Standard Deviation 1.8 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 24 | 2.0 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 2 | 3.2 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 3 | 2.9 units on a scale | Standard Deviation 1.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 4 | 2.8 units on a scale | Standard Deviation 1.4 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 5 | 2.2 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 25 | 1.9 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 6 | 2.3 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 7 | 2.5 units on a scale | Standard Deviation 1.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 10 | 2.5 units on a scale | Standard Deviation 1.4 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 15 | 2.5 units on a scale | Standard Deviation 1.4 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 25 | 2.1 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day -1 | NA units on a scale | — |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 27 | 2.2 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 14 | 2.4 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 5 | 2.8 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 1 | 3.4 units on a scale | Standard Deviation 1.8 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 8 | 2.6 units on a scale | Standard Deviation 1.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 13 | 2.5 units on a scale | Standard Deviation 1.4 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 9 | 2.8 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 2 | 3.3 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 24 | 2.1 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 12 | 2.7 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 7 | 2.7 units on a scale | Standard Deviation 1.6 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 3 | 3.1 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 19 | 2.3 units on a scale | Standard Deviation 1.4 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 28 | 2.1 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 30 | 1.5 units on a scale | Standard Deviation 0.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 20 | 2.2 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 18 | 2.6 units on a scale | Standard Deviation 1.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 17 | 2.6 units on a scale | Standard Deviation 1.4 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 11 | 2.4 units on a scale | Standard Deviation 1.4 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 21 | 2.1 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 6 | 2.6 units on a scale | Standard Deviation 1.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 16 | 2.6 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 4 | 3.1 units on a scale | Standard Deviation 1.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 22 | 2.2 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 29 | 1.7 units on a scale | Standard Deviation 1.2 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 31 | 2.0 units on a scale | — |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 26 | 2.3 units on a scale | Standard Deviation 1.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Duration of Pruritus (Preceding 12 Hours) | Day 23 | 2.3 units on a scale | Standard Deviation 1.2 |
Secondary
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.
Time frame: From baseline to Day 31
Population: Results were collected from a diary that participants were requested to fill in twice a day. Some participants missed some of the entries so there are less than 20 participants analysed for some of the time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 28 | 12.6 mm | Standard Deviation 11.9 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 17 | 28.2 mm | Standard Deviation 19.1 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 18 | 25.6 mm | Standard Deviation 16.2 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 3 | 41.6 mm | Standard Deviation 24.7 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 20 | 25.1 mm | Standard Deviation 17.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 14 | 27.1 mm | Standard Deviation 19.6 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 15 | 29.4 mm | Standard Deviation 19 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 19 | 24.1 mm | Standard Deviation 15.7 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 16 | 28.2 mm | Standard Deviation 16.8 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 24 | 21.1 mm | Standard Deviation 18.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 4 | 37.7 mm | Standard Deviation 21.7 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 10 | 29.4 mm | Standard Deviation 18 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 31 | NA mm | — |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 5 | 33.4 mm | Standard Deviation 23.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 11 | 30.7 mm | Standard Deviation 22.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 30 | 2.0 mm | — |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 6 | 34.1 mm | Standard Deviation 19.5 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 1 | 49.9 mm | Standard Deviation 25.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 7 | 35.2 mm | Standard Deviation 23.5 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 29 | 3.5 mm | Standard Deviation 2.1 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 8 | 31.4 mm | Standard Deviation 16.1 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day -1 | 61.1 mm | Standard Deviation 21.8 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 9 | 32.0 mm | Standard Deviation 20 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 25 | 22.7 mm | Standard Deviation 19.3 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 26 | 23.2 mm | Standard Deviation 18.4 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 23 | 22.2 mm | Standard Deviation 17.9 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 12 | 27.1 mm | Standard Deviation 17.2 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 2 | 43.2 mm | Standard Deviation 24.7 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 13 | 31.0 mm | Standard Deviation 21.9 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 22 | 20.8 mm | Standard Deviation 19.5 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 27 | 20.9 mm | Standard Deviation 21.8 |
| Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 21 | 21.3 mm | Standard Deviation 19.5 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 13 | 34.2 mm | Standard Deviation 21.8 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 6 | 38.4 mm | Standard Deviation 21 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 17 | 29.3 mm | Standard Deviation 21.8 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 24 | 22.0 mm | Standard Deviation 19.1 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 20 | 27.1 mm | Standard Deviation 18 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 26 | 24.0 mm | Standard Deviation 19.2 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 18 | 27.7 mm | Standard Deviation 17.1 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 29 | 7.5 mm | Standard Deviation 0.7 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 2 | 46.7 mm | Standard Deviation 25.1 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 7 | 39.2 mm | Standard Deviation 24.2 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 14 | 31.2 mm | Standard Deviation 19 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 3 | 42.7 mm | Standard Deviation 24.8 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 19 | 27.4 mm | Standard Deviation 19.8 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 1 | 54.7 mm | Standard Deviation 24.6 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 15 | 32.1 mm | Standard Deviation 18.9 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 9 | 35.0 mm | Standard Deviation 21.5 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day -1 | 62.7 mm | Standard Deviation 25.7 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 12 | 31.8 mm | Standard Deviation 16.8 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 16 | 32.8 mm | Standard Deviation 18.3 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 8 | 37.4 mm | Standard Deviation 19.5 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 21 | 23.0 mm | Standard Deviation 19 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 4 | 42.8 mm | Standard Deviation 19.9 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 31 | NA mm | — |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 10 | 34.5 mm | Standard Deviation 19.7 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 28 | 18.9 mm | Standard Deviation 20.1 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 22 | 21.5 mm | Standard Deviation 16.7 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 30 | 4.0 mm | — |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 11 | 37.3 mm | Standard Deviation 23 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 27 | 23.1 mm | Standard Deviation 21.3 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 5 | 39.7 mm | Standard Deviation 23.6 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 25 | 23.8 mm | Standard Deviation 21.3 |
| Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 23 | 24.2 mm | Standard Deviation 18 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 25 | 21.8 mm | Standard Deviation 20.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 10 | 40.0 mm | Standard Deviation 22.8 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day -1 | NA mm | — |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 1 | 56.0 mm | Standard Deviation 25.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 2 | 48.8 mm | Standard Deviation 22.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 3 | 39.5 mm | Standard Deviation 24.5 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 4 | 39.5 mm | Standard Deviation 25.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 5 | 32.3 mm | Standard Deviation 20.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 6 | 34.3 mm | Standard Deviation 21.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 7 | 35.3 mm | Standard Deviation 23.5 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 8 | 32.2 mm | Standard Deviation 20.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 11 | 28.7 mm | Standard Deviation 17.8 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 12 | 31.6 mm | Standard Deviation 22.8 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 26 | 24.1 mm | Standard Deviation 20.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 27 | 19.6 mm | Standard Deviation 18.6 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 17 | 25.5 mm | Standard Deviation 16.7 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 13 | 29.1 mm | Standard Deviation 21.7 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 14 | 30.7 mm | Standard Deviation 21.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 15 | 26.3 mm | Standard Deviation 19.1 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 18 | 29.2 mm | Standard Deviation 18.5 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 16 | 29.1 mm | Standard Deviation 18.9 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 19 | 27.7 mm | Standard Deviation 20.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 20 | 23.2 mm | Standard Deviation 14.5 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 21 | 22.6 mm | Standard Deviation 16.2 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 22 | 20.1 mm | Standard Deviation 16.8 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 23 | 23.2 mm | Standard Deviation 22.3 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 28 | 24.7 mm | Standard Deviation 19.9 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 29 | 5.7 mm | Standard Deviation 7 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 30 | 4.5 mm | Standard Deviation 0.7 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 31 | 3.0 mm | — |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 24 | 20.8 mm | Standard Deviation 17.5 |
| Morning: Aprepitant 10 mg/g Gel | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 9 | 32.8 mm | Standard Deviation 18.8 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 1 | 62.4 mm | Standard Deviation 22 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 21 | 25.7 mm | Standard Deviation 19.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 26 | 23.1 mm | Standard Deviation 18.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 12 | 38.6 mm | Standard Deviation 20.8 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 31 | 4.0 mm | — |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 22 | 22.7 mm | Standard Deviation 15.1 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 11 | 36.8 mm | Standard Deviation 21.1 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 25 | 20.8 mm | Standard Deviation 17.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 3 | 43.6 mm | Standard Deviation 23.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 23 | 21.1 mm | Standard Deviation 16.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 8 | 40.7 mm | Standard Deviation 23 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 2 | 46.7 mm | Standard Deviation 23 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 28 | 24.7 mm | Standard Deviation 21.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 7 | 38.9 mm | Standard Deviation 24.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 6 | 39.1 mm | Standard Deviation 24.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day -1 | NA mm | — |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 29 | 5.9 mm | Standard Deviation 4.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 5 | 41.7 mm | Standard Deviation 21.9 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 4 | 47.7 mm | Standard Deviation 20.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 24 | 21.1 mm | Standard Deviation 16.6 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 30 | 5.5 mm | Standard Deviation 0.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 18 | 30.4 mm | Standard Deviation 16.8 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 15 | 30.7 mm | Standard Deviation 19.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 14 | 31.9 mm | Standard Deviation 21.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 10 | 41.1 mm | Standard Deviation 22.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 19 | 33.1 mm | Standard Deviation 21.7 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 13 | 31.3 mm | Standard Deviation 21.3 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 17 | 29.8 mm | Standard Deviation 17.1 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 9 | 35.9 mm | Standard Deviation 18.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 20 | 23.5 mm | Standard Deviation 17.6 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 16 | 32.9 mm | Standard Deviation 19.5 |
| Morning: Aprepitant Gel Vehicle | Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS | Day 27 | 21.3 mm | Standard Deviation 18.8 |
Secondary
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Lesional Erythema by Mexameter | Day 1 (Visit 2) | 438 units on a scale | Standard Deviation 124 |
| Aprepitant 10 mg/g Gel | Lesional Erythema by Mexameter | Day 14 (Visit 3) | 527 units on a scale | Standard Deviation 122 |
| Aprepitant 10 mg/g Gel | Lesional Erythema by Mexameter | Day 28 (Visit 4) | 464 units on a scale | Standard Deviation 114 |
| Aprepitant 10 mg/g Gel | Lesional Erythema by Mexameter | Day 42 (Visit 5) | 457 units on a scale | Standard Deviation 120 |
| Aprepitant Gel Vehicle | Lesional Erythema by Mexameter | Day 42 (Visit 5) | 461 units on a scale | Standard Deviation 144 |
| Aprepitant Gel Vehicle | Lesional Erythema by Mexameter | Day 1 (Visit 2) | 453 units on a scale | Standard Deviation 107 |
| Aprepitant Gel Vehicle | Lesional Erythema by Mexameter | Day 28 (Visit 4) | 491 units on a scale | Standard Deviation 147 |
| Aprepitant Gel Vehicle | Lesional Erythema by Mexameter | Day 14 (Visit 3) | 463 units on a scale | Standard Deviation 119 |
Secondary
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Melanin by Mexameter | Day 1 (Visit 2) | 131 units on a scale | Standard Deviation 61.6 |
| Aprepitant 10 mg/g Gel | Melanin by Mexameter | Day 14 (Visit 3) | 121 units on a scale | Standard Deviation 43.8 |
| Aprepitant 10 mg/g Gel | Melanin by Mexameter | Day 28 (Visit 4) | 152 units on a scale | Standard Deviation 51.7 |
| Aprepitant 10 mg/g Gel | Melanin by Mexameter | Day 42 (Visit 5) | 132 units on a scale | Standard Deviation 73.2 |
| Aprepitant Gel Vehicle | Melanin by Mexameter | Day 42 (Visit 5) | 144 units on a scale | Standard Deviation 77.5 |
| Aprepitant Gel Vehicle | Melanin by Mexameter | Day 1 (Visit 2) | 115 units on a scale | Standard Deviation 52.4 |
| Aprepitant Gel Vehicle | Melanin by Mexameter | Day 28 (Visit 4) | 139 units on a scale | Standard Deviation 60.3 |
| Aprepitant Gel Vehicle | Melanin by Mexameter | Day 14 (Visit 3) | 134 units on a scale | Standard Deviation 56.8 |
Secondary
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Non-lesional Erythema by Mexameter | Day 1 (Visit 2) | 304 units on a scale | Standard Deviation 151 |
| Aprepitant 10 mg/g Gel | Non-lesional Erythema by Mexameter | Day 14 (Visit 3) | 287 units on a scale | Standard Deviation 84.6 |
| Aprepitant 10 mg/g Gel | Non-lesional Erythema by Mexameter | Day 28 (Visit 4) | 262 units on a scale | Standard Deviation 104 |
| Aprepitant 10 mg/g Gel | Non-lesional Erythema by Mexameter | Day 42 (Visit 5) | 284 units on a scale | Standard Deviation 79.5 |
| Aprepitant Gel Vehicle | Non-lesional Erythema by Mexameter | Day 42 (Visit 5) | 284 units on a scale | Standard Deviation 85.3 |
| Aprepitant Gel Vehicle | Non-lesional Erythema by Mexameter | Day 1 (Visit 2) | 300 units on a scale | Standard Deviation 145 |
| Aprepitant Gel Vehicle | Non-lesional Erythema by Mexameter | Day 28 (Visit 4) | 271 units on a scale | Standard Deviation 71.8 |
| Aprepitant Gel Vehicle | Non-lesional Erythema by Mexameter | Day 14 (Visit 3) | 312 units on a scale | Standard Deviation 138 |
Secondary
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Non-lesional Melanin by Mexameter | Day 1 (Visit 2) | 127 units on a scale | Standard Deviation 58.9 |
| Aprepitant 10 mg/g Gel | Non-lesional Melanin by Mexameter | Day 14 (Visit 3) | 165 units on a scale | Standard Deviation 179 |
| Aprepitant 10 mg/g Gel | Non-lesional Melanin by Mexameter | Day 28 (Visit 4) | 149 units on a scale | Standard Deviation 117 |
| Aprepitant 10 mg/g Gel | Non-lesional Melanin by Mexameter | Day 42 (Visit 5) | 129 units on a scale | Standard Deviation 51.3 |
| Aprepitant Gel Vehicle | Non-lesional Melanin by Mexameter | Day 42 (Visit 5) | 179 units on a scale | Standard Deviation 236 |
| Aprepitant Gel Vehicle | Non-lesional Melanin by Mexameter | Day 1 (Visit 2) | 129 units on a scale | Standard Deviation 49 |
| Aprepitant Gel Vehicle | Non-lesional Melanin by Mexameter | Day 28 (Visit 4) | 166 units on a scale | Standard Deviation 170 |
| Aprepitant Gel Vehicle | Non-lesional Melanin by Mexameter | Day 14 (Visit 3) | 215 units on a scale | Standard Deviation 224 |
Secondary
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.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant 10 mg/g Gel | Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment | 50.8 percent change | Standard Deviation 28.1 |
| Aprepitant Gel Vehicle | Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment | 41.7 percent change | Standard Deviation 29.2 |
Secondary
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Pruritus by VAS (Visual Analogue Scale) | Day 1 (Visit 2) | 50.8 mm | Standard Deviation 26.6 |
| Aprepitant 10 mg/g Gel | Pruritus by VAS (Visual Analogue Scale) | Day 14 (Visit 3) | 27.1 mm | Standard Deviation 24.2 |
| Aprepitant 10 mg/g Gel | Pruritus by VAS (Visual Analogue Scale) | Day 28 (Visit 4) | 19.0 mm | Standard Deviation 21 |
| Aprepitant 10 mg/g Gel | Pruritus by VAS (Visual Analogue Scale) | Day 42 (Visit 5) | 23.9 mm | Standard Deviation 28.2 |
| Aprepitant Gel Vehicle | Pruritus by VAS (Visual Analogue Scale) | Day 42 (Visit 5) | 24.0 mm | Standard Deviation 26.7 |
| Aprepitant Gel Vehicle | Pruritus by VAS (Visual Analogue Scale) | Day 1 (Visit 2) | 58.1 mm | Standard Deviation 28.2 |
| Aprepitant Gel Vehicle | Pruritus by VAS (Visual Analogue Scale) | Day 28 (Visit 4) | 21.9 mm | Standard Deviation 24.2 |
| Aprepitant Gel Vehicle | Pruritus by VAS (Visual Analogue Scale) | Day 14 (Visit 3) | 28.7 mm | Standard Deviation 19.1 |
Secondary
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.
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aprepitant 10 mg/g Gel | Transepidermal Water Loss (TEWL) | Day 1 (Visit 2) | 20.6 g/cm² per hour | Standard Deviation 13.6 |
| Aprepitant 10 mg/g Gel | Transepidermal Water Loss (TEWL) | Day 14 (Visit 3) | 22.7 g/cm² per hour | Standard Deviation 12.5 |
| Aprepitant 10 mg/g Gel | Transepidermal Water Loss (TEWL) | Day 28 (Visit 4) | 20.0 g/cm² per hour | Standard Deviation 19.5 |
| Aprepitant 10 mg/g Gel | Transepidermal Water Loss (TEWL) | Day 42 (Visit 5) | 19.4 g/cm² per hour | Standard Deviation 13.2 |
| Aprepitant Gel Vehicle | Transepidermal Water Loss (TEWL) | Day 42 (Visit 5) | 19.9 g/cm² per hour | Standard Deviation 9.7 |
| Aprepitant Gel Vehicle | Transepidermal Water Loss (TEWL) | Day 1 (Visit 2) | 25.2 g/cm² per hour | Standard Deviation 12.8 |
| Aprepitant Gel Vehicle | Transepidermal Water Loss (TEWL) | Day 28 (Visit 4) | 19.9 g/cm² per hour | Standard Deviation 21.3 |
| Aprepitant Gel Vehicle | Transepidermal Water Loss (TEWL) | Day 14 (Visit 3) | 24.0 g/cm² per hour | Standard Deviation 12.5 |