PruritusPhase 2iTAPPNCT01963793
Topical Aprepitant in Prurigo Patients
A Phase 2 study testing Aprepitant in people with Pruritus, run by LEO Pharma at 1 site in Germany.
Trial summary
Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pruritus
- What is being tested?
- Aprepitant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with Prurigo suffering from chronic pruritus
- Disease duration > six month
- Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressants, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation
- Adult male or female patients, aged 18 to 80 years
Who cannot join
- Concomitant medications that are primarily metabolized through Cytochrome P450 3A4
- Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial
- UV-irradiation during the last 6 weeks prior to Visit 1 (Screening)
- Prescribed systemic medications are limited
- Clinically significant abnormalities in Blood analyses
- Anamnestic excessive use of alcohol or tobacco or drugs
Show all 15Show fewer
- Presence of active tumor disease or history of malignancies within five years prior to Visit 1 (Screening)
- Known or suspected hypersensitivity to component(s) of investigational products
- Within the last 30 days or current participation in any other interventional clinical trial
- Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 6 month
- Previously enrolled/randomised in this clinical trial
- In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)
- Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding
- Females of child-bearing potential with positive pregnancy test
- Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin
Berlin, D-10117
About this study
Official title: Topical Aprepitant in Prurigo Patients An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
- Conditions
- Pruritus
- Being tested
- Aprepitant, Placebo
- Keywords
- Pruritus
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called Aprepitant gel
Aprepitant gel (10 mg/g)
PlaceboDrug
Also called aprepitant gel vehicle
gel without active component
| Study group | Role | What they receive |
|---|---|---|
| placebo (left) / aprepitant (right) | Other | placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body) Receives: Drug: Aprepitant; Drug: Placebo |
| aprepitant (left) / placebo (right) | Other | aprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body) Receives: Drug: Aprepitant; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At end of treatment (Day 28)
Secondary outcomes (15)
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.
Measured: 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.
Measured: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Crusting
The (sub)investigator assessed the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:
Criteria:
Crusts
Evaluation:
0 = not existing
- = mild
- = moderate
- = severe
The score will be an integer on the scale 0-3.
Measured: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Erythema
The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:
Criteria:
Erythema
Evaluation:
0 = not existing
- = mild
- = moderate
- = severe
The score will be an integer on the scale 0-3.
Measured: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Scratch Artefacts
The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:
Criteria:
Scratch artefacts: Superficial damage to the skin caused by severe scratching.
Evaluation:
0 = not existing
- = mild
- = moderate
- = severe
The score will be an integer on the scale 0-3.
Measured: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Infiltration
The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:
Criteria:
Infiltration
Evaluation:
0 = not existing
- = mild
- = moderate
- = severe
The score will be an integer on the scale 0-3.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurer (ICI) Marcus, Prof. Dr. med., Principal investigator, Allergie-Centrum-Charité, Charité Universitätsmedizin Berlin, Charitéplatz1, D-10117 Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963793
- Sponsor's protocol ID
- LP0066-1019
- Acronym
- iTAPP
- Status last verified
- Jun 2021
- First submitted
- 18 Sep 2013
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Aprepitant in Prurigo Patients An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
- ClinicalTrials.gov ID
- NCT01963793
- Acronym / sponsor ID
- iTAPP / LP0066-1019
- Conditions
- Pruritus
- Keywords
- Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Posted 16 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo (left) / aprepitant (right) | Other | Drug: Aprepitant, Drug: Placeboplacebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body) |
| aprepitant (left) / placebo (right) | Other | Drug: Aprepitant, Drug: Placeboaprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with Prurigo suffering from chronic pruritus
- Disease duration > six month
- Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressants, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation
- Adult male or female patients, aged 18 to 80 years
Key exclusion criteria (15 listed)
- Concomitant medications that are primarily metabolized through Cytochrome P450 3A4
- Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial
- UV-irradiation during the last 6 weeks prior to Visit 1 (Screening)
- Prescribed systemic medications are limited
- Clinically significant abnormalities in Blood analyses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AprepitantAlso: Aprepitant gelAprepitant gel (10 mg/g) | Drug | aprepitant (left) / placebo (right), placebo (left) / aprepitant (right) |
| PlaceboAlso: aprepitant gel vehiclegel without active component | Drug | aprepitant (left) / placebo (right), placebo (left) / aprepitant (right) |
Primary outcome
Pruritus by VAS (Visual Analogue Scale)
Time frame: 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.
15 secondary outcomes
Pruritus by VAS (Visual Analogue Scale)
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
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Crusting
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Erythema
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Scratch Artefacts
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Clinical Score Assessment of Infiltration
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Transepidermal Water Loss (TEWL)
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Lesional Erythema by Mexameter
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Non-lesional Erythema by Mexameter
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Melanin by Mexameter
Time frame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
Non-lesional Melanin by Mexameter
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)
Time frame: From baseline to Day 31
Daily Assessments of Average Pruritus by Use of a VAS
Time frame: From baseline to Day 31
Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Time frame: From baseline to Day 31
Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurer (ICI) Marcus, Prof. Dr. med. principal investigator
Allergie-Centrum-Charité, Charité Universitätsmedizin Berlin, Charitéplatz1, D-10117 Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aprepitant in people with Pruritus, run by LEO Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus by VAS (Visual Analogue Scale) (time frame: At end of treatment (Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.