LEO 29102 Cream in the Treatment of Atopic Dermatitis

NCT ID: NCT01037881

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-06-30

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LEO 29102 0.03 mg/g cream

Group Type: EXPERIMENTAL

LEO 29102

Intervention Type: DRUG

comparison of different dosages of drug

LEO 29102 0.1 mg/g cream

Group Type: EXPERIMENTAL

LEO 29102

Intervention Type: DRUG

comparison of different dosages of drug

LEO 29102 0.3 mg/g cream

Group Type: EXPERIMENTAL

LEO 29102

Intervention Type: DRUG

comparison of different dosages of drug

LEO 29102 1.0 mg/g cream

Group Type: EXPERIMENTAL

LEO 29102

Intervention Type: DRUG

comparison of different dosages of drug

LEO 29102 2.5 mg/g cream

Group Type: EXPERIMENTAL

LEO 29102

Intervention Type: DRUG

comparison of different dosages of drug

LEO 29102 cream vehicle

Group Type: PLACEBO_COMPARATOR

LEO 29102

Intervention Type: DRUG

comparison of different dosages of drug

Elidel® cream (pimecrolimus) 10 mg/g

Group Type: ACTIVE_COMPARATOR

Elidel®

Intervention Type: DRUG

comparison

Interventions

LEO 29102

comparison of different dosages of drug

Intervention Type: DRUG

Elidel®

comparison

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

Windsor Clinical Research Inc.

Windsor, Ontario, Canada

Helsinki University Central Hospital

Helsinki, , Finland

Klinik und Poliklinik für Dermatologie, Universität Bonn

Bonn, , Germany

Countries

Canada; Finland; Germany

Other Identifiers

EudraCT Number 2009-013792-22

Identifier Type: REGISTRY

Identifier Source: secondary_id

LEO 29102-C21

Identifier Type: -

Identifier Source: org_study_id