A Phase 2 interventional study of Aprepitant and Placebo in Pruritus, sponsored by LEO Pharma. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by LEO Pharma · Phase 2, Interventional, and Treatment
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Among 58 studies in Pruritus with a site in Germany — 5 open to participants now, 8 under way, 4 of them phase 3. Pruritus · Germany.
Among the 58 studies in Pruritus with a site in Germany, this one is the 53rd largest by enrollment of the 56 interventional ones that give a count, is one of 2 that started in 2013, is one of 17 in phase 2, and was the 12th registered.
491 studies on the registry are indexed under Pruritus; 94 are open to participants now.
Browse Pruritus studies →5 of the 58 studies in Pruritus with a site in Germany are open now. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in Germany, United States, Argentina and 13 more countries
Ages 12–17
Pfizer · Sites in Germany, United States, Bulgaria and 7 more countries
Ages 18+
Mirum Pharmaceuticals, Inc. · Sites in Germany, Belgium, France and 5 more countries
Ages 2 mo+
Sanofi · Sites in Germany, United States, Argentina and 10 more countries
Ages 18–90
AB Science · Sites in Germany, France, Netherlands and 5 more countries
Ages 18–75
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 54 Pruritus studies recruiting now, 22 (41%) set no upper age limit and 24 (44%) stop at 75 or younger; 15 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 24 · Phase 3 25 · Phase 4 4
First in 2005; this study’s year is marked. 2 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 60 across 423 interventional studies indexed under Pruritus.
Median enrollment 153 across the 56 interventional studies, 1,580 across the 2 observational. Of the 50 that completed or were terminated, 31 (62%) have results posted.
This tab as a report to print or save as PDF → With an account.
53 of 58 have an industry lead sponsor. The 10 most frequent:
LEO Pharma is the lead sponsor of 225 studies on the registry; 5 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 24 (75%) have results posted.
LEO Pharma has 1 study filed under Pruritus — fewer than ten, so there is no comparison to draw.
3 of the studies in Pruritus with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05263206Phase 3SanofiEfficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC) | 2027-06-02 |
| NCT07219615PfizerA Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. | 2026-12-25 |
| NCT05050136Mirum Pharmaceuticals, Inc.A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis | 2027-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 58 studies in Pruritus with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body)
Drug: Aprepitant · Drug: Placebo
aprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body)
Drug: Aprepitant · Drug: Placebo
Aprepitant gel (10 mg/g)
Also known as: Aprepitant gel
gel without active component
Also known as: aprepitant gel vehicle
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Aprepitant Gel / Aprepitant Gel Vehicle |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| mm | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Pruritus by VAS (Visual Analogue Scale) | 19.7 (9.5 to 29.8) | 21.2 (11.1 to 31.4) |
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.
| mm | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Day 1 (Visit 2) | 50.8 ± 26.6 | 58.1 ± 28.2 |
| Day 14 (Visit 3) | 27.1 ± 24.2 | 28.7 ± 19.1 |
| Day 28 (Visit 4) | 19.0 ± 21.0 | 21.9 ± 24.2 |
| Day 42 (Visit 5) | 23.9 ± 28.2 | 24.0 ± 26.7 |
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.
| units on a scale | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Day 1 (Visit 2) | 0.0 ± 0.0 | 0.0 ± 0.0 |
| Day 14 (Visit 3) | -0.5 ± 0.8 | -0.7 ± 0.9 |
| Day 28 (Visit 4) | -0.6 ± 1.1 | -0.7 ± 1.1 |
| Day 42 (Visit 5) | -0.3 ± 0.9 | -0.4 ± 0.9 |
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.
| units on a scale | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Day 1 (Visit 2) | 1.3 ± 0.9 | 1.4 ± 0.9 |
| Day 14 (Visit 3) | 0.9 ± 0.9 | 1.1 ± 0.8 |
| Day 28 (Visit 4) | 0.7 ± 0.8 | 1.0 ± 1.1 |
| Day 42 (Visit 5) | 0.8 ± 0.8 | 0.9 ± 0.7 |
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.
| units on a scale | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Day 1 (Visit 2) | 2.0 ± 0.8 | 2.1 ± 0.8 |
| Day 14 (Visit 3) | 1.8 ± 0.9 | 1.8 ± 0.9 |
| Day 28 (Visit 4) | 1.5 ± 0.9 | 1.7 ± 0.9 |
| Day 42 (Visit 5) | 1.5 ± 0.8 | 1.6 ± 0.7 |
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.
| units on a scale | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Day 1 (Visit 2) | 1.7 ± 1.1 | 1.8 ± 1.1 |
| Day 14 (Visit 3) | 1.3 ± 1.1 | 1.3 ± 1.1 |
| Day 28 (Visit 4) | 1.1 ± 1.0 | 1.4 ± 1.1 |
| Day 42 (Visit 5) | 1.4 ± 1.2 | 1.4 ± 1.2 |
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.
| units on a scale | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Day 1 (Visit 2) | 1.5 ± 1.2 | 1.5 ± 1.1 |
| Day 14 (Visit 3) | 1.3 ± 1.0 | 1.4 ± 1.1 |
| Day 28 (Visit 4) | 1.1 ± 0.9 | 1.3 ± 1.0 |
| Day 42 (Visit 5) | 1.3 ± 0.9 | 1.5 ± 1.1 |
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.
| g/cm² per hour | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Day 1 (Visit 2) | 20.6 ± 13.6 | 25.2 ± 12.8 |
| Day 14 (Visit 3) | 22.7 ± 12.5 | 24.0 ± 12.5 |
| Day 28 (Visit 4) | 20.0 ± 19.5 | 19.9 ± 21.3 |
| Day 42 (Visit 5) | 19.4 ± 13.2 | 19.9 ± 9.7 |
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.
| units on a scale | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Day 1 (Visit 2) | 438 ± 124 | 453 ± 107 |
| Day 14 (Visit 3) | 527 ± 122 | 463 ± 119 |
| Day 28 (Visit 4) | 464 ± 114 | 491 ± 147 |
| Day 42 (Visit 5) | 457 ± 120 | 461 ± 144 |
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.
| units on a scale | Lateral Side of Aprepitant 10 mg/g Gel | Lateral Side of Aprepitant Gel Vehicle |
|---|---|---|
| Day 1 (Visit 2) | 304 ± 151 | 300 ± 145 |
| Day 14 (Visit 3) | 287 ± 84.6 | 312 ± 138 |
| Day 28 (Visit 4) | 262 ± 104 | 271 ± 71.8 |
| Day 42 (Visit 5) | 284 ± 79.5 | 284 ± 85.3 |
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.
| units on a scale | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Day 1 (Visit 2) | 131 ± 61.6 | 115 ± 52.4 |
| Day 14 (Visit 3) | 121 ± 43.8 | 134 ± 56.8 |
| Day 28 (Visit 4) | 152 ± 51.7 | 139 ± 60.3 |
| Day 42 (Visit 5) | 132 ± 73.2 | 144 ± 77.5 |
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.
| units on a scale | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Day 1 (Visit 2) | 127 ± 58.9 | 129 ± 49.0 |
| Day 14 (Visit 3) | 165 ± 179 | 215 ± 224 |
| Day 28 (Visit 4) | 149 ± 117 | 166 ± 170 |
| Day 42 (Visit 5) | 129 ± 51.3 | 179 ± 236 |
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.
| units on a scale | Evening: Aprepitant 10 mg/g Gel | Evening: Aprepitant Gel Vehicle | Morning: Aprepitant 10 mg/g Gel | Morning: Aprepitant Gel Vehicle |
|---|---|---|---|---|
| Day -1 | 3.7 ± 1.9 | 4.0 ± 2.1 | NA ± NA | NA ± NA |
| Day 1 | 3.5 ± 1.7 | 3.7 ± 1.6 | 3.0 ± 1.8 | 3.4 ± 1.8 |
| Day 2 | 3.0 ± 1.6 | 3.3 ± 1.7 | 3.2 ± 1.2 | 3.3 ± 1.3 |
| Day 3 | 2.9 ± 1.4 | 3.3 ± 1.6 | 2.9 ± 1.1 | 3.1 ± 1.3 |
| Day 4 | 2.7 ± 1.3 | 3.1 ± 1.4 | 2.8 ± 1.4 | 3.1 ± 1.5 |
| Day 5 | 2.1 ± 1.2 | 2.7 ± 1.5 | 2.2 ± 1.2 | 2.8 ± 1.3 |
| Day 6 | 2.5 ± 1.3 | 2.9 ± 1.4 | 2.3 ± 1.3 | 2.6 ± 1.5 |
| Day 7 | 2.6 ± 1.3 | 2.9 ± 1.4 | 2.5 ± 1.5 | 2.7 ± 1.6 |
| Day 8 | 2.4 ± 1.3 | 2.7 ± 1.5 | 2.3 ± 1.4 | 2.6 ± 1.5 |
| Day 9 | 2.4 ± 1.3 | 2.8 ± 1.4 | 2.4 ± 1.3 | 2.8 ± 1.3 |
| Day 10 | 2.4 ± 1.3 | 2.6 ± 1.5 | 2.4 ± 1.3 | 2.5 ± 1.4 |
| Day 11 | 2.2 ± 1.4 | 2.8 ± 1.5 | 2.0 ± 1.3 | 2.4 ± 1.4 |
| Day 12 | 2.1 ± 1.3 | 2.5 ± 1.4 | 2.2 ± 1.3 | 2.7 ± 1.3 |
| Day 13 | 2.4 ± 1.6 | 2.7 ± 1.5 | 2.2 ± 1.5 | 2.5 ± 1.4 |
| Day 14 | 2.1 ± 1.3 | 2.4 ± 1.4 | 2.1 ± 1.4 | 2.4 ± 1.3 |
| Day 15 | 2.4 ± 1.4 | 2.5 ± 1.4 | 2.1 ± 1.5 | 2.5 ± 1.4 |
| Day 16 | 2.2 ± 1.3 | 2.4 ± 1.4 | 2.1 ± 1.2 | 2.6 ± 1.2 |
| Day 17 | 2.2 ± 1.3 | 2.5 ± 1.3 | 2.1 ± 1.4 | 2.6 ± 1.4 |
| Day 18 | 2.1 ± 1.3 | 2.3 ± 1.2 | 2.2 ± 1.3 | 2.6 ± 1.3 |
| Day 19 | 2.1 ± 1.3 | 2.4 ± 1.3 | 1.9 ± 1.3 | 2.3 ± 1.4 |
| Day 20 | 2.0 ± 1.2 | 2.3 ± 1.2 | 2.0 ± 1.2 | 2.2 ± 1.2 |
| Day 21 | 2.0 ± 1.3 | 2.2 ± 1.2 | 1.9 ± 1.3 | 2.1 ± 1.2 |
| Day 22 | 1.9 ± 1.1 | 2.3 ± 1.2 | 2.0 ± 1.3 | 2.2 ± 1.2 |
| Day 23 | 2.3 ± 1.5 | 2.4 ± 1.5 | 2.0 ± 1.2 | 2.3 ± 1.2 |
| Day 24 | 1.9 ± 1.2 | 2.1 ± 1.2 | 2.0 ± 1.2 | 2.1 ± 1.2 |
| Day 25 | 2.3 ± 1.4 | 2.5 ± 1.3 | 1.9 ± 1.2 | 2.1 ± 1.3 |
| Day 26 | 2.2 ± 1.2 | 2.2 ± 1.3 | 2.4 ± 1.5 | 2.3 ± 1.5 |
| Day 27 | 2.0 ± 1.2 | 2.1 ± 1.2 | 2.1 ± 1.2 | 2.2 ± 1.2 |
| Day 28 | 1.8 ± 1.2 | 2.3 ± 1.2 | 2.0 ± 1.2 | 2.1 ± 1.2 |
| Day 29 | 1.0 ± 0.0 | 2.0 ± 0.0 | 1.5 ± 1.2 | 1.7 ± 1.2 |
| Day 30 | 1.0 ± NA | 2.0 ± NA | 1.0 ± 0.0 | 1.5 ± 0.7 |
| Day 31 | NA ± NA | NA ± NA | 1.0 ± NA | 2.0 ± NA |
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.
| mm | Evening: Aprepitant 10 mg/g Gel | Evening: Aprepitant Gel Vehicle | Morning: Aprepitant 10 mg/g Gel | Morning: Aprepitant Gel Vehicle |
|---|---|---|---|---|
| Day -1 | 49.1 ± 20.9 | 51.3 ± 21.1 | NA ± NA | NA ± NA |
| Day 1 | 45.0 ± 21.5 | 44.7 ± 21.7 | 46.9 ± 21.6 | 49.3 ± 20.6 |
| Day 2 | 35.1 ± 24.1 | 38.9 ± 22.2 | 38.3 ± 18.4 | 39.2 ± 19.0 |
| Day 3 | 33.7 ± 21.0 | 35.8 ± 20.4 | 33.6 ± 21.0 | 33.7 ± 19.7 |
| Day 4 | 31.8 ± 20.2 | 37.5 ± 18.3 | 34.5 ± 22.1 | 37.2 ± 18.7 |
| Day 5 | 27.4 ± 19.6 | 31.0 ± 18.0 | 24.2 ± 16.3 | 33.7 ± 16.9 |
| Day 6 | 26.4 ± 15.9 | 31.5 ± 17.6 | 26.8 ± 17.4 | 30.3 ± 19.1 |
| Day 7 | 30.4 ± 21.7 | 33.2 ± 22.2 | 28.3 ± 20.9 | 31.9 ± 21.9 |
| Day 8 | 23.3 ± 12.6 | 28.8 ± 16.1 | 26.5 ± 18.4 | 30.1 ± 18.8 |
| Day 9 | 24.5 ± 16.6 | 27.6 ± 17.9 | 26.8 ± 17.1 | 27.4 ± 16.0 |
| Day 10 | 22.0 ± 14.8 | 28.2 ± 17.7 | 30.6 ± 21.6 | 30.2 ± 20.6 |
| Day 11 | 23.3 ± 18.8 | 28.4 ± 19.1 | 22.3 ± 15.2 | 29.3 ± 19.0 |
| Day 12 | 19.9 ± 13.4 | 23.7 ± 12.6 | 23.0 ± 17.0 | 27.8 ± 16.8 |
| Day 13 | 21.8 ± 26.0 | 26.4 ± 14.8 | 20.2 ± 13.4 | 23.4 ± 14.5 |
| Day 14 | 20.9 ± 15.4 | 23.1 ± 13.7 | 21.9 ± 15.1 | 24.7 ± 16.1 |
| Day 15 | 24.2 ± 16.9 | 25.2 ± 16.0 | 19.3 ± 14.6 | 22.1 ± 13.0 |
| Day 16 | 20.8 ± 13.6 | 24.3 ± 16.7 | 22.7 ± 15.4 | 25.4 ± 15.3 |
| Day 17 | 20.2 ± 14.6 | 21.7 ± 14.8 | 18.8 ± 14.4 | 22.8 ± 14.3 |
| Day 18 | 18.5 ± 13.6 | 21.1 ± 14.5 | 21.6 ± 13.9 | 22.8 ± 13.0 |
| Day 19 | 15.6 ± 11.2 | 19.9 ± 16.0 | 20.7 ± 14.9 | 22.4 ± 14.7 |
| Day 20 | 16.0 ± 11.9 | 19.7 ± 12.9 | 17.8 ± 13.1 | 18.6 ± 14.9 |
| Day 21 | 14.5 ± 14.6 | 17.0 ± 16.4 | 16.1 ± 13.2 | 17.1 ± 12.4 |
| Day 22 | 14.3 ± 13.2 | 15.9 ± 15.1 | 15.3 ± 14.4 | 16.6 ± 12.8 |
| Day 23 | 15.6 ± 13.6 | 17.2 ± 14.3 | 15.8 ± 16.0 | 14.6 ± 12.7 |
| Day 24 | 15.7 ± 14.1 | 16.7 ± 15.1 | 16.5 ± 16.6 | 15.5 ± 13.4 |
| Day 25 | 18.2 ± 16.4 | 16.8 ± 14.0 | 15.8 ± 14.8 | 16.5 ± 17.0 |
| Day 26 | 15.1 ± 13.1 | 16.6 ± 15.8 | 19.8 ± 17.3 | 16.3 ± 13.5 |
| Day 27 | 14.2 ± 15.4 | 14.1 ± 12.9 | 13.6 ± 13.8 | 14.6 ± 13.0 |
| Day 28 | 7.8 ± 7.5 | 11.6 ± 10.6 | 16.4 ± 14.5 | 14.9 ± 13.5 |
| Day 29 | 3.0 ± 2.8 | 5.5 ± 2.1 | 4.7 ± 6.1 | 4.9 ± 5.6 |
| Day 30 | 3.0 ± NA | 3.0 ± NA | 3.5 ± 2.1 | 3.5 ± 0.7 |
| Day 31 | NA ± NA | NA ± NA | 2.0 ± NA | 2.0 ± NA |
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.
| mm | Evening: Aprepitant 10 mg/g Gel | Evening: Aprepitant Gel Vehicle | Morning: Aprepitant 10 mg/g Gel | Morning: Aprepitant Gel Vehicle |
|---|---|---|---|---|
| Day -1 | 61.1 ± 21.8 | 62.7 ± 25.7 | NA ± NA | NA ± NA |
| Day 1 | 49.9 ± 25.4 | 54.7 ± 24.6 | 56.0 ± 25.3 | 62.4 ± 22.0 |
| Day 2 | 43.2 ± 24.7 | 46.7 ± 25.1 | 48.8 ± 22.2 | 46.7 ± 23.0 |
| Day 3 | 41.6 ± 24.7 | 42.7 ± 24.8 | 39.5 ± 24.5 | 43.6 ± 23.5 |
| Day 4 | 37.7 ± 21.7 | 42.8 ± 19.9 | 39.5 ± 25.1 | 47.7 ± 20.7 |
| Day 5 | 33.4 ± 23.4 | 39.7 ± 23.6 | 32.3 ± 20.1 | 41.7 ± 21.9 |
| Day 6 | 34.1 ± 19.5 | 38.4 ± 21.0 | 34.3 ± 21.1 | 39.1 ± 24.5 |
| Day 7 | 35.2 ± 23.5 | 39.2 ± 24.2 | 35.3 ± 23.5 | 38.9 ± 24.5 |
| Day 8 | 31.4 ± 16.1 | 37.4 ± 19.5 | 32.2 ± 20.3 | 40.7 ± 23.0 |
| Day 9 | 32.0 ± 20.0 | 35.0 ± 21.5 | 32.8 ± 18.8 | 35.9 ± 18.5 |
| Day 10 | 29.4 ± 18.0 | 34.5 ± 19.7 | 40.0 ± 22.8 | 41.1 ± 22.5 |
| Day 11 | 30.7 ± 22.4 | 37.3 ± 23.0 | 28.7 ± 17.8 | 36.8 ± 21.1 |
| Day 12 | 27.1 ± 17.2 | 31.8 ± 16.8 | 31.6 ± 22.8 | 38.6 ± 20.8 |
| Day 13 | 31.0 ± 21.9 | 34.2 ± 21.8 | 29.1 ± 21.7 | 31.3 ± 21.3 |
| Day 14 | 27.1 ± 19.6 | 31.2 ± 19.0 | 30.7 ± 21.2 | 31.9 ± 21.7 |
| Day 15 | 29.4 ± 19.0 | 32.1 ± 18.9 | 26.3 ± 19.1 | 30.7 ± 19.3 |
| Day 16 | 28.2 ± 16.8 | 32.8 ± 18.3 | 29.1 ± 18.9 | 32.9 ± 19.5 |
| Day 17 | 28.2 ± 19.1 | 29.3 ± 21.8 | 25.5 ± 16.7 | 29.8 ± 17.1 |
| Day 18 | 25.6 ± 16.2 | 27.7 ± 17.1 | 29.2 ± 18.5 | 30.4 ± 16.8 |
| Day 19 | 24.1 ± 15.7 | 27.4 ± 19.8 | 27.7 ± 20.2 | 33.1 ± 21.7 |
| Day 20 | 25.1 ± 17.4 | 27.1 ± 18.0 | 23.2 ± 14.5 | 23.5 ± 17.6 |
| Day 21 | 21.3 ± 19.5 | 23.0 ± 19.0 | 22.6 ± 16.2 | 25.7 ± 19.7 |
| Day 22 | 20.8 ± 19.5 | 21.5 ± 16.7 | 20.1 ± 16.8 | 22.7 ± 15.1 |
| Day 23 | 22.2 ± 17.9 | 24.2 ± 18.0 | 23.2 ± 22.3 | 21.1 ± 16.7 |
| Day 24 | 21.1 ± 18.4 | 22.0 ± 19.1 | 20.8 ± 17.5 | 21.1 ± 16.6 |
| Day 25 | 22.7 ± 19.3 | 23.8 ± 21.3 | 21.8 ± 20.1 | 20.8 ± 17.3 |
| Day 26 | 23.2 ± 18.4 | 24.0 ± 19.2 | 24.1 ± 20.2 | 23.1 ± 18.7 |
| Day 27 | 20.9 ± 21.8 | 23.1 ± 21.3 | 19.6 ± 18.6 | 21.3 ± 18.8 |
| Day 28 | 12.6 ± 11.9 | 18.9 ± 20.1 | 24.7 ± 19.9 | 24.7 ± 21.7 |
| Day 29 | 3.5 ± 2.1 | 7.5 ± 0.7 | 5.7 ± 7.0 | 5.9 ± 4.3 |
| Day 30 | 2.0 ± NA | 4.0 ± NA | 4.5 ± 0.7 | 5.5 ± 0.7 |
| Day 31 | NA ± NA | NA ± NA | 3.0 ± NA | 4.0 ± NA |
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.
| percent change | Aprepitant 10 mg/g Gel | Aprepitant Gel Vehicle |
|---|---|---|
| Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment | 50.8 ± 28.1 | 41.7 ± 29.2 |
Collected over From Day 1 to Day 42. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Not Defined | 0/20 (0%) | 0/20 (0%) | 10/20 (50%) |
| Aprepitant Gel Vehicle | 0/20 (0%) | 0/20 (0%) | 15/20 (75%) |
| Aprepitant Gel | 0/20 (0%) | 0/20 (0%) | 11/20 (55%) |
| Event | Treatment Not Defined | Aprepitant Gel Vehicle | Aprepitant Gel |
|---|---|---|---|
| Application site painGeneral disorders | 0/20 | 11/20 | 8/20 |
| Application site discomfortGeneral disorders | 0/20 | 2/20 | 4/20 |
| NasopharyngitisInfections and infestations | 3/20 | 0/20 | 0/20 |
| Application site paraesthesiaGeneral disorders | 0/20 | 2/20 | 1/20 |
| Application site urticariaGeneral disorders | 0/20 | 1/20 | 2/20 |
| ParaesthesiaNervous system disorders | 2/20 | 0/20 | 0/20 |
| Dermatitis allergicSkin and subcutaneous tissue disorders | 2/20 | 0/20 | 0/20 |
| Visual impairmentEye disorders | 1/20 | 0/20 | 0/20 |
| Application site discolourationGeneral disorders | 0/20 | 0/20 | 1/20 |
| Application site erythemaGeneral disorders | 0/20 | 1/20 | 1/20 |
| Age, Continuous(years) | Aprepitant Gel / Aprepitant Gel Vehicle |
|---|---|
| Median | 62.8 ± 11.3 |
| Sex: Female, Male(Participants) | Aprepitant Gel / Aprepitant Gel Vehicle |
|---|---|
| Female | 13 |
| Male | 7 |
| Region of Enrollment(Participants) | Aprepitant Gel / Aprepitant Gel Vehicle |
|---|---|
| Germany | 20 |
Plan to share: No
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The record gives a start of Oct 2013, a primary completion of Jul 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2021, 7 years after primary completion.
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Studies of the drug tested here: Aprepitant