Aprepitant – effect and safety in treatment of atopic dermatitis

Phase 1

• Conditions: Atopic Dermatitis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-002029-40-SE
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-12
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Ongoing atopic dermatitis (diagnosted by dermatologist, Williams criteria).
- Moderate to severe disease (SCORAD > 20).
- Local treatment have not given sufficient effect.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Age over 40 or under 20 years
- Skin infection
- Other sytemic treatment for the atopic dermatitis
- Other diseases
- Other regular medicial treatment (contraceptives not included here)
- Dark skin (skin type VI)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of Aprepitant (Emend) on atpoic dermatitis and prutitus.;Secondary Objective: To investigate inflammatory markers in the skin during treatment with Aprepitant (Emend). ;Primary end point(s): -7 (to 9) days of treatment.;Timepoint(s) of evaluation of this end point: - The day after end of treatment (day 8 in the trial)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -moderate-severe side effects<br>-patient wants to stop treatment;Timepoint(s) of evaluation of this end point: Day after end of treatment period.