LEO 29102 Cream in the Treatment of Atopic Dermatitis

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: LEO 29102; Drug: Elidel®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037881

EudraCT Number 2009-013792-22 (Registry Identifier)

LEO 29102-C21

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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183 participants in 7 patient groups, including a placebo group

LEO 29102 0.03 mg/g cream

Experimental group

Treatment:

Drug: LEO 29102

LEO 29102 0.1 mg/g cream

Experimental group

Treatment:

Drug: LEO 29102

LEO 29102 0.3 mg/g cream

Experimental group

Treatment:

Drug: LEO 29102

LEO 29102 1.0 mg/g cream

Experimental group

Treatment:

Drug: LEO 29102

LEO 29102 2.5 mg/g cream

Experimental group

Treatment:

Drug: LEO 29102

LEO 29102 cream vehicle

Placebo Comparator group

Treatment:

Drug: LEO 29102

Elidel® cream (pimecrolimus) 10 mg/g

Active Comparator group

Treatment:

Drug: Elidel®