Topical Aprepitant in Prurigo Patients (iTAPP)

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Pruritus

Treatments: Drug: Placebo; Drug: Aprepitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01963793

LP0066-1019

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

placebo (left) / aprepitant (right)

Other group

Description:

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

Treatment:

Drug: Aprepitant

Drug: Placebo

aprepitant (left) / placebo (right)

Other group

Description:

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

Treatment:

Drug: Aprepitant

Drug: Placebo