- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037881
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LEO 29102 0.03 mg/g cream
|
comparison of different dosages of drug
|
Experimental: LEO 29102 0.1 mg/g cream
|
comparison of different dosages of drug
|
Experimental: LEO 29102 0.3 mg/g cream
|
comparison of different dosages of drug
|
Experimental: LEO 29102 1.0 mg/g cream
|
comparison of different dosages of drug
|
Experimental: LEO 29102 2.5 mg/g cream
|
comparison of different dosages of drug
|
Placebo Comparator: LEO 29102 cream vehicle
|
comparison of different dosages of drug
|
Active Comparator: Elidel® cream (pimecrolimus) 10 mg/g
|
comparison
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF])
Time Frame: 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
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. |
Baseline (Day 0) and end of treatment (Day 28)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants That Were Symptom Free Responders (LOCF)
Time Frame: 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
Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) at the end of treatment. |
At end of treatment (Day 28)
|
Participants' Assessment of Pruritus on Trunk and Limbs
Time Frame: 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.
The assessment was based on the average degree of pruritus over the last 24 hours. |
At end of treatment (Day 28)
|
Participants' Overall Assessment of Disease Severity
Time Frame: 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. |
At end of treatment (Day 28)
|
Number of Participants That Were Symptom Free Responders by Visit
Time Frame: 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.
|
At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28)
|
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit
Time Frame: 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
|
Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sakari Reitamo, MD, Helsinki University Central Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Eczema
- Dermatitis, Atopic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Calcineurin Inhibitors
- Pimecrolimus
Other Study ID Numbers
- LEO 29102-C21
- EudraCT Number 2009-013792-22 (Registry Identifier: European Clinical Trials Database)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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