A human study to investigate the positive and negative effects of ointments containing roflumilast in patients suffering from a chronic inflammatory skinrash.

Conditions: Atopic Dermatitis Patients with Skin Lesions of Moderate Severity
MedDRA version: 14.1Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2012-003000-12-DE

Lead Sponsor: Takeda Pharma A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Subjects aged 18 to 65 with atopic dermatitis according to Hanifin and Rajka’s criteria, with lesional skin areas of moderate severity, characterized by a modified local SCORAD of at least 4, with an erythema score =2 and confirmed by a qualified investigator. Subjects must have a target lesion of approximately 20 cm2, suitable for topical treatment, and be willing to wash out from current active therapy for atopic dermatitis prior to Day 1.
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 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Subjects who have hypersensitivity to roflumilast or related compounds, a history of atopic dermatitis unresponsive or poorly responsive to topical treatments, a current skin complication such as erythroderma or overt bacterial or viral infection for which treatment with anti-infectives are indicated, have evidence of oozing at the target lesion, or have used any of the excluded medications within the time frames listed in Excluded Medications and Treatments and in the inclusion and exclusion criteria.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the efficacy of dermal 0.5% roflumilast cream formulation compared with vehicle on the reduction of atopic dermatitis lesions during 15 days of treatment in atopic dermatitis patients with skin lesions of moderate severity, using the modified local SCORAD.;Secondary Objective: To assess barrier function by measurement of transepidermal water loss (TEWL)<br><br>To evaluate effect on pruritus, by subjective assessment and recorded on a numeric scale ranging from 0 to 10<br><br>To evaluate the local and systemic safety of a dermal cream of 0.5% roflumilast as measured by rates of AEs relative to vehicle as well as changes in vital signs and clinical laboratory parameters;Primary end point(s): The primary endpoint is the change from baseline to Day 15 in modified local SCORAD (erythema, edema/papulation, oozing/crusts, excoriations, lichenification).;Timepoint(s) of evaluation of this end point: Day 15

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change from baseline to Day 15 in TEWL values<br><br>Change from baseline to Day 15 in subjects’ assessment of pruritus on a numeric scale from 0 to 10;Timepoint(s) of evaluation of this end point: Day 15