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LEO 29102 Cream in the Treatment of Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01037881
Recruitment Status : Completed
First Posted : December 23, 2009
Results First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: LEO 29102 Drug: Elidel® Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: LEO 29102 0.03 mg/g cream Drug: LEO 29102
comparison of different dosages of drug

Experimental: LEO 29102 0.1 mg/g cream Drug: LEO 29102
comparison of different dosages of drug

Experimental: LEO 29102 0.3 mg/g cream Drug: LEO 29102
comparison of different dosages of drug

Experimental: LEO 29102 1.0 mg/g cream Drug: LEO 29102
comparison of different dosages of drug

Experimental: LEO 29102 2.5 mg/g cream Drug: LEO 29102
comparison of different dosages of drug

Placebo Comparator: LEO 29102 cream vehicle Drug: LEO 29102
comparison of different dosages of drug

Active Comparator: Elidel® cream (pimecrolimus) 10 mg/g Drug: Elidel®
comparison




Primary Outcome Measures :
  1. 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

    1. = mild
    2. = moderate
    3. = severe

    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.



Secondary Outcome Measures :
  1. 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

    1. Almost clear - just perceptible erythema, and just perceptible papulation/infiltration
    2. Mild - mild erythema, and mild papulation/infiltration
    3. Moderate - moderate erythema, and moderate papulation/infiltration
    4. Severe - severe erythema, and-severe papulation/infiltration
    5. Very severe - severe erythema, and severe papulation/infiltration with oozing/crusting.

    Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) at the end of treatment.


  2. 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.

    • Absent - no itching
    • Mild - occasional, slight itching
    • Moderate - constant or intermittent itching which is not disturbing sleep
    • Severe - intolerable itching which is disturbing sleep

    The assessment was based on the average degree of pruritus over the last 24 hours.


  3. 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.


  4. 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.

  5. 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

    1. = mild
    2. = moderate
    3. = severe 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037881


Locations
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Canada, Ontario
Windsor Clinical Research Inc.
Windsor, Ontario, Canada, N8W 5L7
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00250
Germany
Klinik und Poliklinik für Dermatologie, Universität Bonn
Bonn, Germany, 53105
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Sakari Reitamo, MD Helsinki University Central Hospital
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01037881    
Other Study ID Numbers: LEO 29102-C21
EudraCT Number 2009-013792-22 ( Registry Identifier: European Clinical Trials Database )
First Posted: December 23, 2009    Key Record Dates
Results First Posted: October 14, 2019
Last Update Posted: October 14, 2019
Last Verified: August 2018
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action