Trial Outcomes & Findings for Topical Aprepitant in Prurigo Patients (NCT NCT01963793)
NCT ID: NCT01963793
Last Updated: 2025-03-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
At end of treatment (Day 28)
Results posted on
2025-03-10
Participant Flow
Participant milestones
| Measure |
Aprepitant Gel / Aprepitant Gel Vehicle
Participants were treated with aprepitant on one extremity and vehicle gel on the other 1:1 thus acting as their own intra-individual controls 10 participants: LEFT: aprepitant 10 mg/g gel , RIGHT: vehicle gel and 10 participants: LEFT: vehicle gel RIGHT: aprepitant 10 mg/g gel
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Aprepitant in Prurigo Patients
Baseline characteristics by cohort
| Measure |
Aprepitant Gel / Aprepitant Gel Vehicle
n=20 Participants
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
|
|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Pruritus by VAS (Visual Analogue Scale)
|
19.7 mm
Interval 9.5 to 29.8
|
21.2 mm
Interval 11.1 to 31.4
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42At 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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Pruritus by VAS (Visual Analogue Scale)
Day 1 (Visit 2)
|
50.8 mm
Standard Deviation 26.6
|
58.1 mm
Standard Deviation 28.2
|
—
|
—
|
|
Pruritus by VAS (Visual Analogue Scale)
Day 14 (Visit 3)
|
27.1 mm
Standard Deviation 24.2
|
28.7 mm
Standard Deviation 19.1
|
—
|
—
|
|
Pruritus by VAS (Visual Analogue Scale)
Day 28 (Visit 4)
|
19.0 mm
Standard Deviation 21.0
|
21.9 mm
Standard Deviation 24.2
|
—
|
—
|
|
Pruritus by VAS (Visual Analogue Scale)
Day 42 (Visit 5)
|
23.9 mm
Standard Deviation 28.2
|
24.0 mm
Standard Deviation 26.7
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42At 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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Change From Baseline in Participants' Global Assessment on Treatment Areas
Day 1 (Visit 2)
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
|
Change From Baseline in Participants' Global Assessment on Treatment Areas
Day 14 (Visit 3)
|
-0.5 units on a scale
Standard Deviation 0.8
|
-0.7 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Change From Baseline in Participants' Global Assessment on Treatment Areas
Day 28 (Visit 4)
|
-0.6 units on a scale
Standard Deviation 1.1
|
-0.7 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Change From Baseline in Participants' Global Assessment on Treatment Areas
Day 42 (Visit 5)
|
-0.3 units on a scale
Standard Deviation 0.9
|
-0.4 units on a scale
Standard Deviation 0.9
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42The (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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Clinical Score Assessment of Crusting
Day 1 (Visit 2)
|
1.3 units on a scale
Standard Deviation 0.9
|
1.4 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Clinical Score Assessment of Crusting
Day 14 (Visit 3)
|
0.9 units on a scale
Standard Deviation 0.9
|
1.1 units on a scale
Standard Deviation 0.8
|
—
|
—
|
|
Clinical Score Assessment of Crusting
Day 28 (Visit 4)
|
0.7 units on a scale
Standard Deviation 0.8
|
1.0 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Clinical Score Assessment of Crusting
Day 42 (Visit 5)
|
0.8 units on a scale
Standard Deviation 0.8
|
0.9 units on a scale
Standard Deviation 0.7
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42The (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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Clinical Score Assessment of Erythema
Day 1 (Visit 2)
|
2.0 units on a scale
Standard Deviation 0.8
|
2.1 units on a scale
Standard Deviation 0.8
|
—
|
—
|
|
Clinical Score Assessment of Erythema
Day 14 (Visit 3)
|
1.8 units on a scale
Standard Deviation 0.9
|
1.8 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Clinical Score Assessment of Erythema
Day 28 (Visit 4)
|
1.5 units on a scale
Standard Deviation 0.9
|
1.7 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Clinical Score Assessment of Erythema
Day 42 (Visit 5)
|
1.5 units on a scale
Standard Deviation 0.8
|
1.6 units on a scale
Standard Deviation 0.7
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42The (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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Clinical Score Assessment of Scratch Artefacts
Day 28 (Visit 4)
|
1.1 units on a scale
Standard Deviation 1.0
|
1.4 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Clinical Score Assessment of Scratch Artefacts
Day 42 (Visit 5)
|
1.4 units on a scale
Standard Deviation 1.2
|
1.4 units on a scale
Standard Deviation 1.2
|
—
|
—
|
|
Clinical Score Assessment of Scratch Artefacts
Day 1 (Visit 2)
|
1.7 units on a scale
Standard Deviation 1.1
|
1.8 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Clinical Score Assessment of Scratch Artefacts
Day 14 (Visit 3)
|
1.3 units on a scale
Standard Deviation 1.1
|
1.3 units on a scale
Standard Deviation 1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42The (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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Clinical Score Assessment of Infiltration
Day 28 (Visit 4)
|
1.1 units on a scale
Standard Deviation 0.9
|
1.3 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Clinical Score Assessment of Infiltration
Day 42 (Visit 5)
|
1.3 units on a scale
Standard Deviation 0.9
|
1.5 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Clinical Score Assessment of Infiltration
Day 1 (Visit 2)
|
1.5 units on a scale
Standard Deviation 1.2
|
1.5 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Clinical Score Assessment of Infiltration
Day 14 (Visit 3)
|
1.3 units on a scale
Standard Deviation 1.0
|
1.4 units on a scale
Standard Deviation 1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42The (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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Transepidermal Water Loss (TEWL)
Day 1 (Visit 2)
|
20.6 g/cm² per hour
Standard Deviation 13.6
|
25.2 g/cm² per hour
Standard Deviation 12.8
|
—
|
—
|
|
Transepidermal Water Loss (TEWL)
Day 14 (Visit 3)
|
22.7 g/cm² per hour
Standard Deviation 12.5
|
24.0 g/cm² per hour
Standard Deviation 12.5
|
—
|
—
|
|
Transepidermal Water Loss (TEWL)
Day 28 (Visit 4)
|
20.0 g/cm² per hour
Standard Deviation 19.5
|
19.9 g/cm² per hour
Standard Deviation 21.3
|
—
|
—
|
|
Transepidermal Water Loss (TEWL)
Day 42 (Visit 5)
|
19.4 g/cm² per hour
Standard Deviation 13.2
|
19.9 g/cm² per hour
Standard Deviation 9.7
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42The 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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Lesional Erythema by Mexameter
Day 1 (Visit 2)
|
438 units on a scale
Standard Deviation 124
|
453 units on a scale
Standard Deviation 107
|
—
|
—
|
|
Lesional Erythema by Mexameter
Day 28 (Visit 4)
|
464 units on a scale
Standard Deviation 114
|
491 units on a scale
Standard Deviation 147
|
—
|
—
|
|
Lesional Erythema by Mexameter
Day 42 (Visit 5)
|
457 units on a scale
Standard Deviation 120
|
461 units on a scale
Standard Deviation 144
|
—
|
—
|
|
Lesional Erythema by Mexameter
Day 14 (Visit 3)
|
527 units on a scale
Standard Deviation 122
|
463 units on a scale
Standard Deviation 119
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42The 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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Non-lesional Erythema by Mexameter
Day 28 (Visit 4)
|
262 units on a scale
Standard Deviation 104
|
271 units on a scale
Standard Deviation 71.8
|
—
|
—
|
|
Non-lesional Erythema by Mexameter
Day 1 (Visit 2)
|
304 units on a scale
Standard Deviation 151
|
300 units on a scale
Standard Deviation 145
|
—
|
—
|
|
Non-lesional Erythema by Mexameter
Day 14 (Visit 3)
|
287 units on a scale
Standard Deviation 84.6
|
312 units on a scale
Standard Deviation 138
|
—
|
—
|
|
Non-lesional Erythema by Mexameter
Day 42 (Visit 5)
|
284 units on a scale
Standard Deviation 79.5
|
284 units on a scale
Standard Deviation 85.3
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42The 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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Melanin by Mexameter
Day 1 (Visit 2)
|
131 units on a scale
Standard Deviation 61.6
|
115 units on a scale
Standard Deviation 52.4
|
—
|
—
|
|
Melanin by Mexameter
Day 14 (Visit 3)
|
121 units on a scale
Standard Deviation 43.8
|
134 units on a scale
Standard Deviation 56.8
|
—
|
—
|
|
Melanin by Mexameter
Day 28 (Visit 4)
|
152 units on a scale
Standard Deviation 51.7
|
139 units on a scale
Standard Deviation 60.3
|
—
|
—
|
|
Melanin by Mexameter
Day 42 (Visit 5)
|
132 units on a scale
Standard Deviation 73.2
|
144 units on a scale
Standard Deviation 77.5
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42The 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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Non-lesional Melanin by Mexameter
Day 1 (Visit 2)
|
127 units on a scale
Standard Deviation 58.9
|
129 units on a scale
Standard Deviation 49.0
|
—
|
—
|
|
Non-lesional Melanin by Mexameter
Day 14 (Visit 3)
|
165 units on a scale
Standard Deviation 179
|
215 units on a scale
Standard Deviation 224
|
—
|
—
|
|
Non-lesional Melanin by Mexameter
Day 28 (Visit 4)
|
149 units on a scale
Standard Deviation 117
|
166 units on a scale
Standard Deviation 170
|
—
|
—
|
|
Non-lesional Melanin by Mexameter
Day 42 (Visit 5)
|
129 units on a scale
Standard Deviation 51.3
|
179 units on a scale
Standard Deviation 236
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Day 31Population: 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.
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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=19 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=19 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
n=19 Participants
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
n=19 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day -1
|
3.7 units on a scale
Standard Deviation 1.9
|
4.0 units on a scale
Standard Deviation 2.1
|
NA units on a scale
Standard Deviation NA
Participants' assessments started on the evening of Day -1 so there is no morning data.
|
NA units on a scale
Standard Deviation NA
Participants' assessments started on the evening of Day -1 so there is no morning data.
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 1
|
3.5 units on a scale
Standard Deviation 1.7
|
3.7 units on a scale
Standard Deviation 1.6
|
3.0 units on a scale
Standard Deviation 1.8
|
3.4 units on a scale
Standard Deviation 1.8
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 2
|
3.0 units on a scale
Standard Deviation 1.6
|
3.3 units on a scale
Standard Deviation 1.7
|
3.2 units on a scale
Standard Deviation 1.2
|
3.3 units on a scale
Standard Deviation 1.3
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 3
|
2.9 units on a scale
Standard Deviation 1.4
|
3.3 units on a scale
Standard Deviation 1.6
|
2.9 units on a scale
Standard Deviation 1.1
|
3.1 units on a scale
Standard Deviation 1.3
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 4
|
2.7 units on a scale
Standard Deviation 1.3
|
3.1 units on a scale
Standard Deviation 1.4
|
2.8 units on a scale
Standard Deviation 1.4
|
3.1 units on a scale
Standard Deviation 1.5
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 5
|
2.1 units on a scale
Standard Deviation 1.2
|
2.7 units on a scale
Standard Deviation 1.5
|
2.2 units on a scale
Standard Deviation 1.2
|
2.8 units on a scale
Standard Deviation 1.3
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 6
|
2.5 units on a scale
Standard Deviation 1.3
|
2.9 units on a scale
Standard Deviation 1.4
|
2.3 units on a scale
Standard Deviation 1.3
|
2.6 units on a scale
Standard Deviation 1.5
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 7
|
2.6 units on a scale
Standard Deviation 1.3
|
2.9 units on a scale
Standard Deviation 1.4
|
2.5 units on a scale
Standard Deviation 1.5
|
2.7 units on a scale
Standard Deviation 1.6
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 8
|
2.4 units on a scale
Standard Deviation 1.3
|
2.7 units on a scale
Standard Deviation 1.5
|
2.3 units on a scale
Standard Deviation 1.4
|
2.6 units on a scale
Standard Deviation 1.5
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 9
|
2.4 units on a scale
Standard Deviation 1.3
|
2.8 units on a scale
Standard Deviation 1.4
|
2.4 units on a scale
Standard Deviation 1.3
|
2.8 units on a scale
Standard Deviation 1.3
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 10
|
2.4 units on a scale
Standard Deviation 1.3
|
2.6 units on a scale
Standard Deviation 1.5
|
2.4 units on a scale
Standard Deviation 1.3
|
2.5 units on a scale
Standard Deviation 1.4
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 11
|
2.2 units on a scale
Standard Deviation 1.4
|
2.8 units on a scale
Standard Deviation 1.5
|
2.0 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.4
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 12
|
2.1 units on a scale
Standard Deviation 1.3
|
2.5 units on a scale
Standard Deviation 1.4
|
2.2 units on a scale
Standard Deviation 1.3
|
2.7 units on a scale
Standard Deviation 1.3
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 13
|
2.4 units on a scale
Standard Deviation 1.6
|
2.7 units on a scale
Standard Deviation 1.5
|
2.2 units on a scale
Standard Deviation 1.5
|
2.5 units on a scale
Standard Deviation 1.4
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 14
|
2.1 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.4
|
2.1 units on a scale
Standard Deviation 1.4
|
2.4 units on a scale
Standard Deviation 1.3
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 15
|
2.4 units on a scale
Standard Deviation 1.4
|
2.5 units on a scale
Standard Deviation 1.4
|
2.1 units on a scale
Standard Deviation 1.5
|
2.5 units on a scale
Standard Deviation 1.4
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 16
|
2.2 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.4
|
2.1 units on a scale
Standard Deviation 1.2
|
2.6 units on a scale
Standard Deviation 1.2
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 17
|
2.2 units on a scale
Standard Deviation 1.3
|
2.5 units on a scale
Standard Deviation 1.3
|
2.1 units on a scale
Standard Deviation 1.4
|
2.6 units on a scale
Standard Deviation 1.4
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 18
|
2.1 units on a scale
Standard Deviation 1.3
|
2.3 units on a scale
Standard Deviation 1.2
|
2.2 units on a scale
Standard Deviation 1.3
|
2.6 units on a scale
Standard Deviation 1.3
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 19
|
2.1 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.3
|
1.9 units on a scale
Standard Deviation 1.3
|
2.3 units on a scale
Standard Deviation 1.4
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 20
|
2.0 units on a scale
Standard Deviation 1.2
|
2.3 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.2
|
2.2 units on a scale
Standard Deviation 1.2
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 23
|
2.3 units on a scale
Standard Deviation 1.5
|
2.4 units on a scale
Standard Deviation 1.5
|
2.0 units on a scale
Standard Deviation 1.2
|
2.3 units on a scale
Standard Deviation 1.2
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 24
|
1.9 units on a scale
Standard Deviation 1.2
|
2.1 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.2
|
2.1 units on a scale
Standard Deviation 1.2
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 25
|
2.3 units on a scale
Standard Deviation 1.4
|
2.5 units on a scale
Standard Deviation 1.3
|
1.9 units on a scale
Standard Deviation 1.2
|
2.1 units on a scale
Standard Deviation 1.3
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 26
|
2.2 units on a scale
Standard Deviation 1.2
|
2.2 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.5
|
2.3 units on a scale
Standard Deviation 1.5
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 27
|
2.0 units on a scale
Standard Deviation 1.2
|
2.1 units on a scale
Standard Deviation 1.2
|
2.1 units on a scale
Standard Deviation 1.2
|
2.2 units on a scale
Standard Deviation 1.2
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 28
|
1.8 units on a scale
Standard Deviation 1.2
|
2.3 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.2
|
2.1 units on a scale
Standard Deviation 1.2
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 29
|
1.0 units on a scale
Standard Deviation 0.0
|
2.0 units on a scale
Standard Deviation 0.0
|
1.5 units on a scale
Standard Deviation 1.2
|
1.7 units on a scale
Standard Deviation 1.2
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 30
|
1.0 units on a scale
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
2.0 units on a scale
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
1.0 units on a scale
Standard Deviation 0.0
|
1.5 units on a scale
Standard Deviation 0.7
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 31
|
NA units on a scale
Standard Deviation NA
Participants' assessments ended on the morning of Day 31 so there is no evening data.
|
NA units on a scale
Standard Deviation NA
Participants' assessments ended on the morning of Day 31 so there is no evening data.
|
1.0 units on a scale
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
2.0 units on a scale
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 21
|
2.0 units on a scale
Standard Deviation 1.3
|
2.2 units on a scale
Standard Deviation 1.2
|
1.9 units on a scale
Standard Deviation 1.3
|
2.1 units on a scale
Standard Deviation 1.2
|
|
Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Day 22
|
1.9 units on a scale
Standard Deviation 1.1
|
2.3 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.3
|
2.2 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: From baseline to Day 31Population: 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.
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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day -1
|
49.1 mm
Standard Deviation 20.9
|
51.3 mm
Standard Deviation 21.1
|
NA mm
Standard Deviation NA
Participants' assessments started on the evening of Day -1 so there is no morning data.
|
NA mm
Standard Deviation NA
Participants' assessments started on the evening of Day -1 so there is no morning data.
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 1
|
45.0 mm
Standard Deviation 21.5
|
44.7 mm
Standard Deviation 21.7
|
46.9 mm
Standard Deviation 21.6
|
49.3 mm
Standard Deviation 20.6
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 2
|
35.1 mm
Standard Deviation 24.1
|
38.9 mm
Standard Deviation 22.2
|
38.3 mm
Standard Deviation 18.4
|
39.2 mm
Standard Deviation 19.0
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 3
|
33.7 mm
Standard Deviation 21.0
|
35.8 mm
Standard Deviation 20.4
|
33.6 mm
Standard Deviation 21.0
|
33.7 mm
Standard Deviation 19.7
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 4
|
31.8 mm
Standard Deviation 20.2
|
37.5 mm
Standard Deviation 18.3
|
34.5 mm
Standard Deviation 22.1
|
37.2 mm
Standard Deviation 18.7
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 5
|
27.4 mm
Standard Deviation 19.6
|
31.0 mm
Standard Deviation 18.0
|
24.2 mm
Standard Deviation 16.3
|
33.7 mm
Standard Deviation 16.9
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 6
|
26.4 mm
Standard Deviation 15.9
|
31.5 mm
Standard Deviation 17.6
|
26.8 mm
Standard Deviation 17.4
|
30.3 mm
Standard Deviation 19.1
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 7
|
30.4 mm
Standard Deviation 21.7
|
33.2 mm
Standard Deviation 22.2
|
28.3 mm
Standard Deviation 20.9
|
31.9 mm
Standard Deviation 21.9
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 9
|
24.5 mm
Standard Deviation 16.6
|
27.6 mm
Standard Deviation 17.9
|
26.8 mm
Standard Deviation 17.1
|
27.4 mm
Standard Deviation 16.0
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 13
|
21.8 mm
Standard Deviation 26.0
|
26.4 mm
Standard Deviation 14.8
|
20.2 mm
Standard Deviation 13.4
|
23.4 mm
Standard Deviation 14.5
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 14
|
20.9 mm
Standard Deviation 15.4
|
23.1 mm
Standard Deviation 13.7
|
21.9 mm
Standard Deviation 15.1
|
24.7 mm
Standard Deviation 16.1
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 23
|
15.6 mm
Standard Deviation 13.6
|
17.2 mm
Standard Deviation 14.3
|
15.8 mm
Standard Deviation 16.0
|
14.6 mm
Standard Deviation 12.7
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 24
|
15.7 mm
Standard Deviation 14.1
|
16.7 mm
Standard Deviation 15.1
|
16.5 mm
Standard Deviation 16.6
|
15.5 mm
Standard Deviation 13.4
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 25
|
18.2 mm
Standard Deviation 16.4
|
16.8 mm
Standard Deviation 14.0
|
15.8 mm
Standard Deviation 14.8
|
16.5 mm
Standard Deviation 17.0
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 29
|
3.0 mm
Standard Deviation 2.8
|
5.5 mm
Standard Deviation 2.1
|
4.7 mm
Standard Deviation 6.1
|
4.9 mm
Standard Deviation 5.6
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 8
|
23.3 mm
Standard Deviation 12.6
|
28.8 mm
Standard Deviation 16.1
|
26.5 mm
Standard Deviation 18.4
|
30.1 mm
Standard Deviation 18.8
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 10
|
22.0 mm
Standard Deviation 14.8
|
28.2 mm
Standard Deviation 17.7
|
30.6 mm
Standard Deviation 21.6
|
30.2 mm
Standard Deviation 20.6
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 11
|
23.3 mm
Standard Deviation 18.8
|
28.4 mm
Standard Deviation 19.1
|
22.3 mm
Standard Deviation 15.2
|
29.3 mm
Standard Deviation 19.0
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 12
|
19.9 mm
Standard Deviation 13.4
|
23.7 mm
Standard Deviation 12.6
|
23.0 mm
Standard Deviation 17.0
|
27.8 mm
Standard Deviation 16.8
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 15
|
24.2 mm
Standard Deviation 16.9
|
25.2 mm
Standard Deviation 16.0
|
19.3 mm
Standard Deviation 14.6
|
22.1 mm
Standard Deviation 13.0
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 16
|
20.8 mm
Standard Deviation 13.6
|
24.3 mm
Standard Deviation 16.7
|
22.7 mm
Standard Deviation 15.4
|
25.4 mm
Standard Deviation 15.3
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 17
|
20.2 mm
Standard Deviation 14.6
|
21.7 mm
Standard Deviation 14.8
|
18.8 mm
Standard Deviation 14.4
|
22.8 mm
Standard Deviation 14.3
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 18
|
18.5 mm
Standard Deviation 13.6
|
21.1 mm
Standard Deviation 14.5
|
21.6 mm
Standard Deviation 13.9
|
22.8 mm
Standard Deviation 13.0
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 19
|
15.6 mm
Standard Deviation 11.2
|
19.9 mm
Standard Deviation 16.0
|
20.7 mm
Standard Deviation 14.9
|
22.4 mm
Standard Deviation 14.7
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 20
|
16.0 mm
Standard Deviation 11.9
|
19.7 mm
Standard Deviation 12.9
|
17.8 mm
Standard Deviation 13.1
|
18.6 mm
Standard Deviation 14.9
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 21
|
14.5 mm
Standard Deviation 14.6
|
17.0 mm
Standard Deviation 16.4
|
16.1 mm
Standard Deviation 13.2
|
17.1 mm
Standard Deviation 12.4
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 22
|
14.3 mm
Standard Deviation 13.2
|
15.9 mm
Standard Deviation 15.1
|
15.3 mm
Standard Deviation 14.4
|
16.6 mm
Standard Deviation 12.8
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 26
|
15.1 mm
Standard Deviation 13.1
|
16.6 mm
Standard Deviation 15.8
|
19.8 mm
Standard Deviation 17.3
|
16.3 mm
Standard Deviation 13.5
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 27
|
14.2 mm
Standard Deviation 15.4
|
14.1 mm
Standard Deviation 12.9
|
13.6 mm
Standard Deviation 13.8
|
14.6 mm
Standard Deviation 13.0
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 28
|
7.8 mm
Standard Deviation 7.5
|
11.6 mm
Standard Deviation 10.6
|
16.4 mm
Standard Deviation 14.5
|
14.9 mm
Standard Deviation 13.5
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 30
|
3.0 mm
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
3.0 mm
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
3.5 mm
Standard Deviation 2.1
|
3.5 mm
Standard Deviation 0.7
|
|
Daily Assessments of Average Pruritus by Use of a VAS
Day 31
|
NA mm
Standard Deviation NA
Participants' assessments ended on the morning of Day 31 so there is no evening data.
|
NA mm
Standard Deviation NA
Participants' assessments ended on the morning of Day 31 so there is no evening data.
|
2.0 mm
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
2.0 mm
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
SECONDARY outcome
Timeframe: From baseline to Day 31Population: 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.
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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 3
|
41.6 mm
Standard Deviation 24.7
|
42.7 mm
Standard Deviation 24.8
|
39.5 mm
Standard Deviation 24.5
|
43.6 mm
Standard Deviation 23.5
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 27
|
20.9 mm
Standard Deviation 21.8
|
23.1 mm
Standard Deviation 21.3
|
19.6 mm
Standard Deviation 18.6
|
21.3 mm
Standard Deviation 18.8
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 28
|
12.6 mm
Standard Deviation 11.9
|
18.9 mm
Standard Deviation 20.1
|
24.7 mm
Standard Deviation 19.9
|
24.7 mm
Standard Deviation 21.7
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 10
|
29.4 mm
Standard Deviation 18.0
|
34.5 mm
Standard Deviation 19.7
|
40.0 mm
Standard Deviation 22.8
|
41.1 mm
Standard Deviation 22.5
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 11
|
30.7 mm
Standard Deviation 22.4
|
37.3 mm
Standard Deviation 23.0
|
28.7 mm
Standard Deviation 17.8
|
36.8 mm
Standard Deviation 21.1
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 12
|
27.1 mm
Standard Deviation 17.2
|
31.8 mm
Standard Deviation 16.8
|
31.6 mm
Standard Deviation 22.8
|
38.6 mm
Standard Deviation 20.8
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 29
|
3.5 mm
Standard Deviation 2.1
|
7.5 mm
Standard Deviation 0.7
|
5.7 mm
Standard Deviation 7.0
|
5.9 mm
Standard Deviation 4.3
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 30
|
2.0 mm
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
4.0 mm
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
4.5 mm
Standard Deviation 0.7
|
5.5 mm
Standard Deviation 0.7
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 13
|
31.0 mm
Standard Deviation 21.9
|
34.2 mm
Standard Deviation 21.8
|
29.1 mm
Standard Deviation 21.7
|
31.3 mm
Standard Deviation 21.3
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 14
|
27.1 mm
Standard Deviation 19.6
|
31.2 mm
Standard Deviation 19.0
|
30.7 mm
Standard Deviation 21.2
|
31.9 mm
Standard Deviation 21.7
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 15
|
29.4 mm
Standard Deviation 19.0
|
32.1 mm
Standard Deviation 18.9
|
26.3 mm
Standard Deviation 19.1
|
30.7 mm
Standard Deviation 19.3
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 16
|
28.2 mm
Standard Deviation 16.8
|
32.8 mm
Standard Deviation 18.3
|
29.1 mm
Standard Deviation 18.9
|
32.9 mm
Standard Deviation 19.5
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 17
|
28.2 mm
Standard Deviation 19.1
|
29.3 mm
Standard Deviation 21.8
|
25.5 mm
Standard Deviation 16.7
|
29.8 mm
Standard Deviation 17.1
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 18
|
25.6 mm
Standard Deviation 16.2
|
27.7 mm
Standard Deviation 17.1
|
29.2 mm
Standard Deviation 18.5
|
30.4 mm
Standard Deviation 16.8
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 19
|
24.1 mm
Standard Deviation 15.7
|
27.4 mm
Standard Deviation 19.8
|
27.7 mm
Standard Deviation 20.2
|
33.1 mm
Standard Deviation 21.7
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 20
|
25.1 mm
Standard Deviation 17.4
|
27.1 mm
Standard Deviation 18.0
|
23.2 mm
Standard Deviation 14.5
|
23.5 mm
Standard Deviation 17.6
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 21
|
21.3 mm
Standard Deviation 19.5
|
23.0 mm
Standard Deviation 19.0
|
22.6 mm
Standard Deviation 16.2
|
25.7 mm
Standard Deviation 19.7
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 22
|
20.8 mm
Standard Deviation 19.5
|
21.5 mm
Standard Deviation 16.7
|
20.1 mm
Standard Deviation 16.8
|
22.7 mm
Standard Deviation 15.1
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 23
|
22.2 mm
Standard Deviation 17.9
|
24.2 mm
Standard Deviation 18.0
|
23.2 mm
Standard Deviation 22.3
|
21.1 mm
Standard Deviation 16.7
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 24
|
21.1 mm
Standard Deviation 18.4
|
22.0 mm
Standard Deviation 19.1
|
20.8 mm
Standard Deviation 17.5
|
21.1 mm
Standard Deviation 16.6
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 31
|
NA mm
Standard Deviation NA
Participants' assessments ended on the morning of Day 31 so there is no evening data.
|
NA mm
Standard Deviation NA
Participants' assessments ended on the morning of Day 31 so there is no evening data.
|
3.0 mm
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
4.0 mm
Standard Deviation NA
This value has not been calculated because only one person was analyzed.
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 25
|
22.7 mm
Standard Deviation 19.3
|
23.8 mm
Standard Deviation 21.3
|
21.8 mm
Standard Deviation 20.1
|
20.8 mm
Standard Deviation 17.3
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 26
|
23.2 mm
Standard Deviation 18.4
|
24.0 mm
Standard Deviation 19.2
|
24.1 mm
Standard Deviation 20.2
|
23.1 mm
Standard Deviation 18.7
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 9
|
32.0 mm
Standard Deviation 20.0
|
35.0 mm
Standard Deviation 21.5
|
32.8 mm
Standard Deviation 18.8
|
35.9 mm
Standard Deviation 18.5
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day -1
|
61.1 mm
Standard Deviation 21.8
|
62.7 mm
Standard Deviation 25.7
|
NA mm
Standard Deviation NA
Participants' assessments started on the evening of Day -1 so there is no morning data.
|
NA mm
Standard Deviation NA
Participants' assessments started on the evening of Day -1 so there is no morning data.
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 1
|
49.9 mm
Standard Deviation 25.4
|
54.7 mm
Standard Deviation 24.6
|
56.0 mm
Standard Deviation 25.3
|
62.4 mm
Standard Deviation 22.0
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 2
|
43.2 mm
Standard Deviation 24.7
|
46.7 mm
Standard Deviation 25.1
|
48.8 mm
Standard Deviation 22.2
|
46.7 mm
Standard Deviation 23.0
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 4
|
37.7 mm
Standard Deviation 21.7
|
42.8 mm
Standard Deviation 19.9
|
39.5 mm
Standard Deviation 25.1
|
47.7 mm
Standard Deviation 20.7
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 5
|
33.4 mm
Standard Deviation 23.4
|
39.7 mm
Standard Deviation 23.6
|
32.3 mm
Standard Deviation 20.1
|
41.7 mm
Standard Deviation 21.9
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 6
|
34.1 mm
Standard Deviation 19.5
|
38.4 mm
Standard Deviation 21.0
|
34.3 mm
Standard Deviation 21.1
|
39.1 mm
Standard Deviation 24.5
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 7
|
35.2 mm
Standard Deviation 23.5
|
39.2 mm
Standard Deviation 24.2
|
35.3 mm
Standard Deviation 23.5
|
38.9 mm
Standard Deviation 24.5
|
|
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Day 8
|
31.4 mm
Standard Deviation 16.1
|
37.4 mm
Standard Deviation 19.5
|
32.2 mm
Standard Deviation 20.3
|
40.7 mm
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: Day 28On 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.
Outcome measures
| Measure |
Aprepitant 10 mg/g Gel
n=20 Participants
20 participants treated with aprepitant 10mg/g gel on either left or right extremity
|
Aprepitant Gel Vehicle
n=20 Participants
20 participants were treated with vehicle gel on either left or right extremity
|
Morning: Aprepitant 10 mg/g Gel
20 participants treated with aprepitant 10 mg/g gel on either left or right extremity
|
Morning: Aprepitant Gel Vehicle
20 participants were treated with vehicle gel on either left or right extremity
|
|---|---|---|---|---|
|
Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment
|
50.8 percent change
Standard Deviation 28.1
|
41.7 percent change
Standard Deviation 29.2
|
—
|
—
|
Adverse Events
Treatment Not Defined
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Aprepitant Gel Vehicle
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Aprepitant Gel
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Not Defined
n=20 participants at risk
The treatment for these adverse events are not defined
|
Aprepitant Gel Vehicle
n=20 participants at risk
Placebo (Aprepitant gel vehicle)
|
Aprepitant Gel
n=20 participants at risk
10 mg/g aprepitant gel
|
|---|---|---|---|
|
Eye disorders
Visual impairment
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
General disorders
Application site discolouration
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
|
General disorders
Application site discomfort
|
0.00%
0/20 • From Day 1 to Day 42
|
10.0%
2/20 • From Day 1 to Day 42
|
20.0%
4/20 • From Day 1 to Day 42
|
|
General disorders
Application site erythema
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
|
General disorders
Application site haemorrhage
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
General disorders
Application site nodule
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
|
General disorders
Application site pain
|
0.00%
0/20 • From Day 1 to Day 42
|
55.0%
11/20 • From Day 1 to Day 42
|
40.0%
8/20 • From Day 1 to Day 42
|
|
General disorders
Application site paraesthesia
|
0.00%
0/20 • From Day 1 to Day 42
|
10.0%
2/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
|
General disorders
Application site pruritus
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
|
General disorders
Application site urticaria
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
10.0%
2/20 • From Day 1 to Day 42
|
|
General disorders
Application site vesicles
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
|
General disorders
Fatigue
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
3/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
|
Infections and infestations
Wound infection
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Nervous system disorders
Paraesthesia
|
10.0%
2/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Psychiatric disorders
Restlessness
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
10.0%
2/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Surgical and medical procedures
Wound treatment
|
0.00%
0/20 • From Day 1 to Day 42
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Vascular disorders
Flushing
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
|
Vascular disorders
Hot flush
|
5.0%
1/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
0.00%
0/20 • From Day 1 to Day 42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submitting or presenting a manuscript relating to the clinical trial to a publisher, reviewer or other outside person, the Investigator shall submit to LEO, in writing, a copy of the intended publication, describing the detail of any Research Results that the Investigator intends to Publish, at least 60 days before the date of the proposed submission for publication.
- Publication restrictions are in place
Restriction type: OTHER