Topical Aprepitant in Prurigo Patients

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma
• Treatments: Aprepitant; Fosaprepitant

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)