Topical Aprepitant in Prurigo Patients (NCT01963793) | Clinical Trial Compass
CompletedPhase 2
Topical Aprepitant in Prurigo Patients
Germany20 participantsStarted 2013-10
Plain-language summary
Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 u…