Topical Aprepitant in Prurigo Patients

NCT01963793 | Completed Phase 2 Results

• 1 other identifier: LP0066-1019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pruritus

Keywords

Pruritus

Outcome Measures

Primary Outcomes (1)

• 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.

  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

• Change From Baseline in Participants' Global Assessment on Treatment Areas

  At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

• Clinical Score Assessment of Crusting

  At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

• Clinical Score Assessment of Erythema

  At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

• Clinical Score Assessment of Scratch Artefacts

  At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

Study Arms (2)

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)

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)

Drug: Aprepitant; Drug: Placebo

Interventions

Aprepitant DRUG

Aprepitant gel (10 mg/g)

Also known as: Aprepitant gel

aprepitant (left) / placebo (right); placebo (left) / aprepitant (right)

Placebo DRUG

gel without active component

Also known as: aprepitant gel vehicle

aprepitant (left) / placebo (right); placebo (left) / aprepitant (right)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin

Berlin, D-10117, Germany

Location

MeSH Terms

Conditions

Pruritus

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Maurer (ICI) Marcus, Prof. Dr. med.

  Allergie-Centrum-Charité, Charité Universitätsmedizin Berlin, Charitéplatz1, D-10117 Berlin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: October 16, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 10, 2025
• Results First Posted: July 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)