This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
183
Windsor Clinical Research Inc.
Windsor, Ontario, Canada
Helsinki University Central Hospital
Helsinki, Finland
Klinik und Poliklinik für Dermatologie, Universität Bonn
Bonn, Germany
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF])
The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved. For each body region, the investigator rated four clinical signs of AD using the following severity scale: 0 = none/absent 1. = mild 2. = moderate 3. = severe The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country.
Time frame: Baseline (Day 0) and end of treatment (Day 28)
Number of Participants That Were Symptom Free Responders (LOCF)
The IGA (Investigator's global assessment) of disease severity on the body (trunk and limbs excluding the hands) was assessed based on visual evaluation by use of the following definitions of severity: 0\. Clear - no inflammatory signs of AD 1. Almost clear - just perceptible erythema, and just perceptible papulation/infiltration 2. Mild - mild erythema, and mild papulation/infiltration 3. Moderate - moderate erythema, and moderate papulation/infiltration 4. Severe - severe erythema, and-severe papulation/infiltration 5. Very severe - severe erythema, and severe papulation/infiltration with oozing/crusting. Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) at the end of treatment.
Time frame: At end of treatment (Day 28)
Participants' Assessment of Pruritus on Trunk and Limbs
Participants' assessment of pruritus on trunk and limbs was assessed at end of treatment by use of the scale below. * Absent - no itching * Mild - occasional, slight itching * Moderate - constant or intermittent itching which is not disturbing sleep * Severe - intolerable itching which is disturbing sleep The assessment was based on the average degree of pruritus over the last 24 hours.
Time frame: At end of treatment (Day 28)
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Participants' Overall Assessment of Disease Severity
Participants' overall assessment of disease severity on trunk and limbs (excluding the hands) was assessed at end of treatment by use of the following scale: clear, very mild, mild, moderate, severe. The assessment was based on the condition of the disease at the time of the evaluation and not in relation to the condition at a previous visit.
Time frame: At end of treatment (Day 28)
Number of Participants That Were Symptom Free Responders by Visit
Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) according to Investigator's global assessment of disease severity on trunk and limbs at the end of treatment.
Time frame: At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28)
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit
The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved. For each body region, the investigator rated four clinical signs of AD using the following severity scale: 0 = none/absent 1. = mild 2. = moderate 3. = severe The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country.
Time frame: Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21)