LEO 29102 Cream in the Treatment of Atopic Dermatitis
- Registration Number
- NCT01037881
- Lead Sponsor
- LEO Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LEO 29102 0.03 mg/g cream LEO 29102 - LEO 29102 0.1 mg/g cream LEO 29102 - LEO 29102 0.3 mg/g cream LEO 29102 - LEO 29102 1.0 mg/g cream LEO 29102 - LEO 29102 2.5 mg/g cream LEO 29102 - Elidel® cream (pimecrolimus) 10 mg/g Elidel® - LEO 29102 cream vehicle LEO 29102 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.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.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.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.
Trial Locations
- Locations (3)
Windsor Clinical Research Inc.
🇨🇦Windsor, Ontario, Canada
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Klinik und Poliklinik für Dermatologie, Universität Bonn
🇩🇪Bonn, Germany