Topical Aprepitant in Prurigo Patients

NCT ID: NCT01963793

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-07-31

Brief Summary

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

Conditions

Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo (left) / aprepitant (right)

placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body)

Group Type: OTHER

Aprepitant

Intervention Type: DRUG

Aprepitant gel (10 mg/g)

Placebo

Intervention Type: DRUG

gel without active component

aprepitant (left) / placebo (right)

aprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body)

Group Type: OTHER

Aprepitant

Intervention Type: DRUG

Aprepitant gel (10 mg/g)

Placebo

Intervention Type: DRUG

gel without active component

Interventions

Aprepitant

Aprepitant gel (10 mg/g)

Intervention Type: DRUG

Placebo

gel without active component

Intervention Type: DRUG

Other Intervention Names

Aprepitant gel; aprepitant gel vehicle

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurer (ICI) Marcus, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

LP0066-1019

Identifier Type: -

Identifier Source: org_study_id