Clinical trial NCT01037881: LEO 29102 Cream in the Treatment of Atopic Dermatitis
Official title: A Phase 2, Proof of Concept and Dose Finding Study, Investigating Treatment Efficacy of LEO 29102 Cream, LEO 29102 Cream Vehicle, and Elidel® Cream 10 mg/g, After Cutaneous Administration Twice Daily for 4 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF])
timeFrame: Baseline (Day 0) and end of treatment (Day 28)
Secondary outcomes:
measure: Number of Participants That Were Symptom Free Responders (LOCF)
timeFrame: At end of treatment (Day 28)
measure: Participants' Assessment of Pruritus on Trunk and Limbs
timeFrame: At end of treatment (Day 28)
measure: Participants' Overall Assessment of Disease Severity
timeFrame: At end of treatment (Day 28)
measure: Number of Participants That Were Symptom Free Responders by Visit
timeFrame: At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28)
measure: Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit
timeFrame: Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21)
Other outcomes:
Locations:
city: Windsor
country: Canada
facility: Windsor Clinical Research Inc.
state: Ontario
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Bonn
country: Germany
facility: Klinik und Poliklinik für Dermatologie, Universität Bonn
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: