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Completed

NCT Number: NCT01037881

LEO 29102 Cream in the Treatment of Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Windsor Clinical Research Inc., Windsor, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEO 29102

Drug

comparison of different dosages of drug

Elidel®

Drug

comparison

Primary outcomes

  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

    • = mild
    • = moderate
    • = 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 outcomes

  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:

    • Clear - no inflammatory signs of AD
    • Almost clear - just perceptible erythema, and just perceptible papulation/infiltration
    • Mild - mild erythema, and mild papulation/infiltration
    • Moderate - moderate erythema, and moderate papulation/infiltration
    • Severe - severe erythema, and-severe papulation/infiltration
    • 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

    • = mild
    • = moderate
    • = 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.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 23, 2009
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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