Topical Aprepitant in Prurigo Patients (iTAPP)

This study is currently recruiting participants.
Verified February 2014 by LEO Pharma
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01963793
First received: September 18, 2013
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Pruritus
Drug: Aprepitant
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Aprepitant in Prurigo Patients An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • efficacy of topical aprepitant treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To investigate the efficacy of topical treatment with aprepitant on pruritus compared to placebo, after 4 weeks of treatment using VAS (Visual Analogue Score)


Secondary Outcome Measures:
  • efficacy of topical applied aprepitant [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess efficacy of topical applied aprepitant on the status of the skin condition compared to placebo, after 4 weeks of treatment using patient global assessment and clinical score

  • long-term effect of topical applied aprepitant [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To assess long-term effect (e.g., duration of action, duration of reduction of pruritus) of topical applied aprepitant in comparison to placebo, after a follow up period of 2 weeks at the end of the treatment

  • effect of topical applied aprepitant on skin structures [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess effect of topical applied aprepitant on skin structures in comparison to placebo, after 4 weeks of treatment using TEWL (Transepidermal Water Loss)


Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: Aprepitant
Aprepitant gel (10 mg/g)
Other Name: Aprepitant gel
Drug: Placebo
gel without active component
Other Name: aprepitant gel vehicle
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)
Drug: Aprepitant
Aprepitant gel (10 mg/g)
Other Name: Aprepitant gel
Drug: Placebo
gel without active component
Other Name: aprepitant gel vehicle

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01963793

Contacts
Contact: Claudia Miranda Foca-Fuchs +49 (0)6102 201-0 ext -207 claudia.miranda@leo-pharma.com

Locations
Germany
Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, D-10117
Contact: Martin Metz, Prof. Dr.    +49 (0) 30 450518 ext 972    martin.metz@charite.de   
Principal Investigator: Martin Metz, Prof.Dr.med         
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Maurer (ICI) Marcus, Prof. Dr. med. Allergie-Centrum-Charité, Charité Universitätsmedizin Berlin, Charitéplatz1, D-10117 Berlin
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01963793     History of Changes
Other Study ID Numbers: LP0066-1019
Study First Received: September 18, 2013
Last Updated: February 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by LEO Pharma:
Pruritus

Additional relevant MeSH terms:
Pruritus
Prurigo
Skin Diseases
Skin Manifestations
Signs and Symptoms
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 16, 2014