Atopic Dermatitis
Conditions
Brief summary
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.
Interventions
DRUGLEO 29102
comparison of different dosages of drug
DRUGElidel®
comparison
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of atopic dermatitis defined according to Hanifin and Rajka * IGA assessment scored as mild (2) to moderate (3) atopic dermatitis * Treatment lesions located on the trunk and limbs * Treatment lesions involving 3% to 10% of the total body surface area * Patients of either gender between 18 years and 65 years of age
Exclusion criteria
* Systemic treatment with immunosuppressive drugs or corticosteroids within 6 weeks prior to randomisation * Topical treatment with immunomodulators (pimecrolimus, tacrolimus) within 2 weeks prior to randomisation * Topical treatment with corticosteroids from WHO groups II, III or IV within 1 week prior to randomisation * Use of topical or systemic antibiotics within 2 weeks prior to randomisation * PUVA or UVB therapy within 4 weeks prior to randomisation * Clinical infection (viral, fungal or bacterial) on the treatment area * Known or suspected severe renal insufficiency or severe hepatic disorders * Patients with history of an immunocompromised disease (e.g., lymphoma, HIV, Wiskott-Aldrich Syndrome) * Patients with concomitant serious disease (e.g., cancer) which might affect the AD treatment in this trial * Females who are pregnant or are breast feeding * Females intending to temporarily or permanently stop their hormonal contraceptive regime during and up to one month post study termination visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) | Baseline (Day 0) and end of treatment (Day 28) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Were Symptom Free Responders (LOCF) | At end of treatment (Day 28) | 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. |
| Participants' Assessment of Pruritus on Trunk and Limbs | At end of treatment (Day 28) | 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. |
| Participants' Overall Assessment of Disease Severity | At end of treatment (Day 28) | 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. |
| Number of Participants That Were Symptom Free Responders by Visit | At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28) | 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. |
| Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) | 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. |
Countries
Canada, Finland, Germany
Participant flow
Recruitment details
Participants received investigational medicinal products for up to 4-weeks followed by a 28 day follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| LEO 29102 Vehicle Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks | 25 |
| LEO 29102 0.03 mg/g Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 24 |
| LEO 29102 0.1 mg/g Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 25 |
| LEO 29102 0.3 mg/g Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 25 |
| LEO 29102 1.0 mg/g Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 29 |
| LEO 29102 2.5 mg/g Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks | 30 |
| Elidel® 10 mg/g Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks | 25 |
| Total | 183 |
Baseline characteristics
| Characteristic | LEO 29102 Vehicle | LEO 29102 0.03 mg/g | LEO 29102 0.1 mg/g | LEO 29102 0.3 mg/g | LEO 29102 1.0 mg/g | LEO 29102 2.5 mg/g | Elidel® 10 mg/g | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.1 years STANDARD_DEVIATION 14 | 36.2 years STANDARD_DEVIATION 14.4 | 34.9 years STANDARD_DEVIATION 11.8 | 38.3 years STANDARD_DEVIATION 12.6 | 32.0 years STANDARD_DEVIATION 10 | 35.5 years STANDARD_DEVIATION 13.7 | 29.9 years STANDARD_DEVIATION 8.8 | 35.1 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment Canada | 4 participants | 6 participants | 5 participants | 6 participants | 6 participants | 6 participants | 4 participants | 37 participants |
| Region of Enrollment Finland | 3 participants | 0 participants | 2 participants | 2 participants | 6 participants | 6 participants | 3 participants | 22 participants |
| Region of Enrollment Germany | 18 participants | 18 participants | 18 participants | 17 participants | 17 participants | 18 participants | 18 participants | 124 participants |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 10 Participants | 4 Participants | 15 Participants | 13 Participants | 9 Participants | 70 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 15 Participants | 21 Participants | 14 Participants | 17 Participants | 16 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 25 | 11 / 24 | 8 / 25 | 8 / 25 | 8 / 28 | 8 / 30 | 8 / 25 | 1 / 25 | 0 / 24 | 2 / 25 | 0 / 25 | 2 / 28 | 4 / 30 | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 | 0 / 25 | 0 / 25 | 0 / 28 | 0 / 30 | 0 / 25 | 0 / 25 | 0 / 24 | 0 / 25 | 0 / 25 | 0 / 28 | 0 / 30 | 0 / 25 |
Outcome results
Primary
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)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LEO 29102 Vehicle | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) | -0.85 units on a scale | Standard Deviation 6.85 |
| LEO 29102 0.03 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) | -2.13 units on a scale | Standard Deviation 3 |
| LEO 29102 0.1 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) | -1.09 units on a scale | Standard Deviation 5.81 |
| LEO 29102 0.3 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) | -2.86 units on a scale | Standard Deviation 2.99 |
| LEO 29102 1.0 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) | -2.41 units on a scale | Standard Deviation 2.38 |
| LEO 29102 2.5 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) | -2.50 units on a scale | Standard Deviation 3.28 |
| Elidel® 10 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF]) | -3.30 units on a scale | Standard Deviation 2.51 |
Comparison: Active treatment minus vehicle, adjusted for the effect of (pooled) country.p-value: 0.2795% CI: [-3.6, 1.03]ANOVA
Comparison: Active treatment minus vehicle, adjusted for the effect of (pooled) country.p-value: 0.8395% CI: [-2.53, 2.04]ANOVA
Comparison: Active treatment minus vehicle, adjusted for the effect of (pooled) country.p-value: 0.0895% CI: [-4.3, 0.28]ANOVA
Comparison: Active treatment minus vehicle, adjusted for the effect of (pooled) country.p-value: 0.1695% CI: [-3.77, 0.65]ANOVA
Comparison: Active treatment minus vehicle, adjusted for the effect of (pooled) country.p-value: 0.1495% CI: [-3.84, 0.54]ANOVA
Comparison: Active treatment minus vehicle, adjusted for the effect of (pooled) country.p-value: 0.0495% CI: [-4.47, -0.17]ANOVA
Comparison: LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.p-value: 0.0495% CI: [0.17, 4.74]ANOVA
Comparison: LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.p-value: 0.3295% CI: [-1.14, 3.48]ANOVA
Comparison: LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.p-value: 0.0695% CI: [-0.08, 4.5]ANOVA
Comparison: LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.p-value: 0.795% CI: [-1.84, 2.73]ANOVA
Comparison: LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.p-value: 0.4295% CI: [-1.31, 3.1]ANOVA
Comparison: LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.p-value: 0.4795% CI: [-1.38, 3]ANOVA
Secondary
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)
Population: Data was tabulated using an observed cases approach and therefore only contains data from participants who attended the specific visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 29102 Vehicle | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 4 (Day 21) | -1.62 units on a scale | Standard Deviation 4.18 |
| LEO 29102 Vehicle | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 3 (Day 14) | -1.77 units on a scale | Standard Deviation 2.77 |
| LEO 29102 Vehicle | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 2 (Day 7) | -0.09 units on a scale | Standard Deviation 5.27 |
| LEO 29102 0.03 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 3 (Day 14) | -1.48 units on a scale | Standard Deviation 2.19 |
| LEO 29102 0.03 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 2 (Day 7) | -1.26 units on a scale | Standard Deviation 1.72 |
| LEO 29102 0.03 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 4 (Day 21) | -1.76 units on a scale | Standard Deviation 2.67 |
| LEO 29102 0.1 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 4 (Day 21) | -0.89 units on a scale | Standard Deviation 5.94 |
| LEO 29102 0.1 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 2 (Day 7) | -0.93 units on a scale | Standard Deviation 1.82 |
| LEO 29102 0.1 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 3 (Day 14) | -1.30 units on a scale | Standard Deviation 2.28 |
| LEO 29102 0.3 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 3 (Day 14) | -2.19 units on a scale | Standard Deviation 3.14 |
| LEO 29102 0.3 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 2 (Day 7) | -1.43 units on a scale | Standard Deviation 2.53 |
| LEO 29102 0.3 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 4 (Day 21) | -2.21 units on a scale | Standard Deviation 3.27 |
| LEO 29102 1.0 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 3 (Day 14) | -1.67 units on a scale | Standard Deviation 2.15 |
| LEO 29102 1.0 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 2 (Day 7) | -1.64 units on a scale | Standard Deviation 1.71 |
| LEO 29102 1.0 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 4 (Day 21) | -1.90 units on a scale | Standard Deviation 2.57 |
| LEO 29102 2.5 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 2 (Day 7) | -1.48 units on a scale | Standard Deviation 2.28 |
| LEO 29102 2.5 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 4 (Day 21) | -2.53 units on a scale | Standard Deviation 2.18 |
| LEO 29102 2.5 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 3 (Day 14) | -1.52 units on a scale | Standard Deviation 3.17 |
| Elidel® 10 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 4 (Day 21) | -2.16 units on a scale | Standard Deviation 2.22 |
| Elidel® 10 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 3 (Day 14) | -1.82 units on a scale | Standard Deviation 2.39 |
| Elidel® 10 mg/g | Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit | Visit 2 (Day 7) | -1.21 units on a scale | Standard Deviation 2.17 |
Secondary
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)
Population: Occurrences of early withdrawal, non-compliance, prohibited medication, missing application of study medication and participants missing visits resulted in not all participants being analyzed at all visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 29102 Vehicle | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Non-responder | 23 Participants |
| LEO 29102 Vehicle | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Responder | 6 Participants |
| LEO 29102 Vehicle | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Responder | 4 Participants |
| LEO 29102 Vehicle | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Responder | 2 Participants |
| LEO 29102 Vehicle | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Non-responder | 13 Participants |
| LEO 29102 Vehicle | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Responder | 4 Participants |
| LEO 29102 Vehicle | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Non-responder | 17 Participants |
| LEO 29102 Vehicle | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Non-responder | 16 Participants |
| LEO 29102 0.03 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Non-responder | 23 Participants |
| LEO 29102 0.03 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Responder | 2 Participants |
| LEO 29102 0.03 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Non-responder | 20 Participants |
| LEO 29102 0.03 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Non-responder | 22 Participants |
| LEO 29102 0.03 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Responder | 2 Participants |
| LEO 29102 0.03 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Responder | 1 Participants |
| LEO 29102 0.03 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Responder | 1 Participants |
| LEO 29102 0.03 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Non-responder | 20 Participants |
| LEO 29102 0.1 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Non-responder | 17 Participants |
| LEO 29102 0.1 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Responder | 5 Participants |
| LEO 29102 0.1 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Responder | 6 Participants |
| LEO 29102 0.1 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Non-responder | 17 Participants |
| LEO 29102 0.1 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Responder | 2 Participants |
| LEO 29102 0.1 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Non-responder | 23 Participants |
| LEO 29102 0.1 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Non-responder | 20 Participants |
| LEO 29102 0.1 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Responder | 3 Participants |
| LEO 29102 0.3 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Non-responder | 16 Participants |
| LEO 29102 0.3 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Responder | 9 Participants |
| LEO 29102 0.3 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Responder | 1 Participants |
| LEO 29102 0.3 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Responder | 3 Participants |
| LEO 29102 0.3 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Non-responder | 23 Participants |
| LEO 29102 0.3 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Non-responder | 15 Participants |
| LEO 29102 0.3 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Non-responder | 21 Participants |
| LEO 29102 0.3 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Responder | 7 Participants |
| LEO 29102 1.0 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Non-responder | 20 Participants |
| LEO 29102 1.0 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Responder | 5 Participants |
| LEO 29102 1.0 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Responder | 5 Participants |
| LEO 29102 1.0 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Responder | 10 Participants |
| LEO 29102 1.0 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Non-responder | 23 Participants |
| LEO 29102 1.0 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Non-responder | 16 Participants |
| LEO 29102 1.0 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Responder | 5 Participants |
| LEO 29102 1.0 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Non-responder | 22 Participants |
| LEO 29102 2.5 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Non-responder | 16 Participants |
| LEO 29102 2.5 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Responder | 5 Participants |
| LEO 29102 2.5 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Non-responder | 25 Participants |
| LEO 29102 2.5 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Responder | 7 Participants |
| LEO 29102 2.5 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Non-responder | 22 Participants |
| LEO 29102 2.5 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Responder | 11 Participants |
| LEO 29102 2.5 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Responder | 12 Participants |
| LEO 29102 2.5 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Non-responder | 15 Participants |
| Elidel® 10 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Non-responder | 11 Participants |
| Elidel® 10 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 5 (Day 28) | Responder | 12 Participants |
| Elidel® 10 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Non-responder | 16 Participants |
| Elidel® 10 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 3 (Day 14) | Responder | 8 Participants |
| Elidel® 10 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Non-responder | 23 Participants |
| Elidel® 10 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 2 (Day 7) | Responder | 2 Participants |
| Elidel® 10 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Non-responder | 15 Participants |
| Elidel® 10 mg/g | Number of Participants That Were Symptom Free Responders by Visit | Visit 4 (Day 21) | Responder | 8 Participants |
Secondary
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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 29102 Vehicle | Number of Participants That Were Symptom Free Responders (LOCF) | Non-responder | 19 Participants |
| LEO 29102 Vehicle | Number of Participants That Were Symptom Free Responders (LOCF) | Responder | 6 Participants |
| LEO 29102 0.03 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Non-responder | 22 Participants |
| LEO 29102 0.03 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Responder | 2 Participants |
| LEO 29102 0.1 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Responder | 5 Participants |
| LEO 29102 0.1 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Non-responder | 20 Participants |
| LEO 29102 0.3 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Non-responder | 16 Participants |
| LEO 29102 0.3 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Responder | 9 Participants |
| LEO 29102 1.0 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Non-responder | 19 Participants |
| LEO 29102 1.0 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Responder | 10 Participants |
| LEO 29102 2.5 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Responder | 13 Participants |
| LEO 29102 2.5 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Non-responder | 17 Participants |
| Elidel® 10 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Non-responder | 13 Participants |
| Elidel® 10 mg/g | Number of Participants That Were Symptom Free Responders (LOCF) | Responder | 12 Participants |
Secondary
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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 29102 Vehicle | Participants' Assessment of Pruritus on Trunk and Limbs | Severe | 4 Participants |
| LEO 29102 Vehicle | Participants' Assessment of Pruritus on Trunk and Limbs | Absent | 5 Participants |
| LEO 29102 Vehicle | Participants' Assessment of Pruritus on Trunk and Limbs | Moderate | 8 Participants |
| LEO 29102 Vehicle | Participants' Assessment of Pruritus on Trunk and Limbs | Mild | 8 Participants |
| LEO 29102 0.03 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Mild | 7 Participants |
| LEO 29102 0.03 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Severe | 7 Participants |
| LEO 29102 0.03 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Absent | 1 Participants |
| LEO 29102 0.03 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Moderate | 9 Participants |
| LEO 29102 0.1 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Absent | 4 Participants |
| LEO 29102 0.1 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Mild | 9 Participants |
| LEO 29102 0.1 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Moderate | 9 Participants |
| LEO 29102 0.1 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Severe | 3 Participants |
| LEO 29102 0.3 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Mild | 7 Participants |
| LEO 29102 0.3 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Moderate | 11 Participants |
| LEO 29102 0.3 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Absent | 7 Participants |
| LEO 29102 0.3 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Severe | 0 Participants |
| LEO 29102 1.0 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Absent | 5 Participants |
| LEO 29102 1.0 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Mild | 15 Participants |
| LEO 29102 1.0 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Moderate | 8 Participants |
| LEO 29102 1.0 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Severe | 1 Participants |
| LEO 29102 2.5 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Mild | 13 Participants |
| LEO 29102 2.5 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Absent | 7 Participants |
| LEO 29102 2.5 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Severe | 4 Participants |
| LEO 29102 2.5 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Moderate | 6 Participants |
| Elidel® 10 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Severe | 1 Participants |
| Elidel® 10 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Absent | 6 Participants |
| Elidel® 10 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Moderate | 4 Participants |
| Elidel® 10 mg/g | Participants' Assessment of Pruritus on Trunk and Limbs | Mild | 14 Participants |
Secondary
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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 29102 Vehicle | Participants' Overall Assessment of Disease Severity | Very mild | 5 Participants |
| LEO 29102 Vehicle | Participants' Overall Assessment of Disease Severity | Mild | 8 Participants |
| LEO 29102 Vehicle | Participants' Overall Assessment of Disease Severity | Severe | 4 Participants |
| LEO 29102 Vehicle | Participants' Overall Assessment of Disease Severity | Moderate | 6 Participants |
| LEO 29102 Vehicle | Participants' Overall Assessment of Disease Severity | Clear | 2 Participants |
| LEO 29102 0.03 mg/g | Participants' Overall Assessment of Disease Severity | Very mild | 1 Participants |
| LEO 29102 0.03 mg/g | Participants' Overall Assessment of Disease Severity | Clear | 1 Participants |
| LEO 29102 0.03 mg/g | Participants' Overall Assessment of Disease Severity | Mild | 10 Participants |
| LEO 29102 0.03 mg/g | Participants' Overall Assessment of Disease Severity | Moderate | 9 Participants |
| LEO 29102 0.03 mg/g | Participants' Overall Assessment of Disease Severity | Severe | 3 Participants |
| LEO 29102 0.1 mg/g | Participants' Overall Assessment of Disease Severity | Moderate | 7 Participants |
| LEO 29102 0.1 mg/g | Participants' Overall Assessment of Disease Severity | Clear | 2 Participants |
| LEO 29102 0.1 mg/g | Participants' Overall Assessment of Disease Severity | Severe | 3 Participants |
| LEO 29102 0.1 mg/g | Participants' Overall Assessment of Disease Severity | Very mild | 4 Participants |
| LEO 29102 0.1 mg/g | Participants' Overall Assessment of Disease Severity | Mild | 9 Participants |
| LEO 29102 0.3 mg/g | Participants' Overall Assessment of Disease Severity | Severe | 1 Participants |
| LEO 29102 0.3 mg/g | Participants' Overall Assessment of Disease Severity | Moderate | 11 Participants |
| LEO 29102 0.3 mg/g | Participants' Overall Assessment of Disease Severity | Mild | 5 Participants |
| LEO 29102 0.3 mg/g | Participants' Overall Assessment of Disease Severity | Clear | 3 Participants |
| LEO 29102 0.3 mg/g | Participants' Overall Assessment of Disease Severity | Very mild | 5 Participants |
| LEO 29102 1.0 mg/g | Participants' Overall Assessment of Disease Severity | Very mild | 5 Participants |
| LEO 29102 1.0 mg/g | Participants' Overall Assessment of Disease Severity | Clear | 4 Participants |
| LEO 29102 1.0 mg/g | Participants' Overall Assessment of Disease Severity | Mild | 10 Participants |
| LEO 29102 1.0 mg/g | Participants' Overall Assessment of Disease Severity | Moderate | 10 Participants |
| LEO 29102 1.0 mg/g | Participants' Overall Assessment of Disease Severity | Severe | 0 Participants |
| LEO 29102 2.5 mg/g | Participants' Overall Assessment of Disease Severity | Mild | 10 Participants |
| LEO 29102 2.5 mg/g | Participants' Overall Assessment of Disease Severity | Moderate | 4 Participants |
| LEO 29102 2.5 mg/g | Participants' Overall Assessment of Disease Severity | Clear | 1 Participants |
| LEO 29102 2.5 mg/g | Participants' Overall Assessment of Disease Severity | Very mild | 12 Participants |
| LEO 29102 2.5 mg/g | Participants' Overall Assessment of Disease Severity | Severe | 3 Participants |
| Elidel® 10 mg/g | Participants' Overall Assessment of Disease Severity | Severe | 1 Participants |
| Elidel® 10 mg/g | Participants' Overall Assessment of Disease Severity | Mild | 8 Participants |
| Elidel® 10 mg/g | Participants' Overall Assessment of Disease Severity | Moderate | 3 Participants |
| Elidel® 10 mg/g | Participants' Overall Assessment of Disease Severity | Very mild | 11 Participants |
| Elidel® 10 mg/g | Participants' Overall Assessment of Disease Severity | Clear | 2 Participants |