Atopic Dermatitis Patients with Skin Lesions of Moderate Severity MedDRA version: 14.1 Level: PT Classification code 10012438 Term: Dermatitis atopic System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: 0.5% roflumilast cream
Pharmaceutical Form: Cream
INN or Proposed INN: ROFLUMILAST
CAS Number: 162401-32-3
Current Sponsor code: BY217
Concentration unit: % percent
Concentration type: e
Sponsors
Takeda Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) To evaluate effect on pruritus, by subjective assessment and recorded on a numeric scale ranging from 0 to 10 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline to Day 15 in TEWL values 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 | — |
Countries
Germany
Contacts
Public ContactClinical Trial Manager
Takeda Pharma A/S
Outcome results
None listed