LEO 29102 Cream in the Treatment of Atopic Dermatitis

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

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.

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