Clinical trial NCT01963793: Topical Aprepitant in Prurigo Patients
Official title: Topical Aprepitant in Prurigo Patients An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus
Keywords: Pruritus
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2013-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo


Eligibility criteria: Inclusion Criteria:

* Patient with Prurigo suffering from chronic pruritus
* Disease duration \> six month
* Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressants, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation
* Adult male or female patients, aged 18 to 80 years

Exclusion Criteria:

* Concomitant medications that are primarily metabolized through Cytochrome P450 3A4
* Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial
* UV-irradiation during the last 6 weeks prior to Visit 1 (Screening)
* Prescribed systemic medications are limited
* Clinically significant abnormalities in Blood analyses
* Anamnestic excessive use of alcohol or tobacco or drugs
* Presence of active tumor disease or history of malignancies within five years prior to Visit 1 (Screening)
* Known or suspected hypersensitivity to component(s) of investigational products
* Within the last 30 days or current participation in any other interventional clinical trial
* Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 6 month
* Previously enrolled/randomised in this clinical trial
* In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)
* Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding
* Females of child-bearing potential with positive pregnancy test
* Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)

Primary outcomes:
measure: Pruritus by VAS (Visual Analogue Scale)
timeFrame: At end of treatment (Day 28)
Secondary outcomes:
measure: Pruritus by VAS (Visual Analogue Scale)
timeFrame: At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42
measure: Change From Baseline in Participants' Global Assessment on Treatment Areas
timeFrame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
measure: Clinical Score Assessment of Crusting
timeFrame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
measure: Clinical Score Assessment of Erythema
timeFrame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
measure: Clinical Score Assessment of Scratch Artefacts
timeFrame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
measure: Clinical Score Assessment of Infiltration
timeFrame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
measure: Transepidermal Water Loss (TEWL)
timeFrame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
measure: Lesional Erythema by Mexameter
timeFrame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
measure: Non-lesional Erythema by Mexameter
timeFrame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
measure: Melanin by Mexameter
timeFrame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
measure: Non-lesional Melanin by Mexameter
timeFrame: At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42
measure: Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
timeFrame: From baseline to Day 31
measure: Daily Assessments of Average Pruritus by Use of a VAS
timeFrame: From baseline to Day 31
measure: Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
timeFrame: From baseline to Day 31
measure: Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment
timeFrame: Day 28
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Allergie-Centrum-Charité, Charité Universitätsmedizin Berlin, Charitéplatz1, D-10117 Berlin
name: Maurer (ICI) Marcus, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: