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LEO 29102 Cream in the Treatment of Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LEO 29102
Elidel®
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Windsor Clinical Research Inc.
  • Helsinki University Central Hospital
  • Klinik und Poliklinik für Dermatologie, Universität Bonn

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

LEO 29102 0.03 mg/g cream

LEO 29102 0.1 mg/g cream

LEO 29102 0.3 mg/g cream

LEO 29102 1.0 mg/g cream

LEO 29102 2.5 mg/g cream

LEO 29102 cream vehicle

Elidel® cream (pimecrolimus) 10 mg/g

Arm Description

Outcomes

Primary Outcome Measures

Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF])
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 Outcome Measures

Number of Participants That Were Symptom Free Responders (LOCF)
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 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.
Participants' Assessment of Pruritus on Trunk and Limbs
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.
Participants' Overall Assessment of Disease Severity
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.
Number of Participants That Were Symptom Free Responders by Visit
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.
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit
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.

Full Information

First Posted
December 21, 2009
Last Updated
September 24, 2019
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01037881
Brief Title
LEO 29102 Cream in the Treatment of Atopic Dermatitis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 29102 0.03 mg/g cream
Arm Type
Experimental
Arm Title
LEO 29102 0.1 mg/g cream
Arm Type
Experimental
Arm Title
LEO 29102 0.3 mg/g cream
Arm Type
Experimental
Arm Title
LEO 29102 1.0 mg/g cream
Arm Type
Experimental
Arm Title
LEO 29102 2.5 mg/g cream
Arm Type
Experimental
Arm Title
LEO 29102 cream vehicle
Arm Type
Placebo Comparator
Arm Title
Elidel® cream (pimecrolimus) 10 mg/g
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
LEO 29102
Intervention Description
comparison of different dosages of drug
Intervention Type
Drug
Intervention Name(s)
Elidel®
Intervention Description
comparison
Primary Outcome Measure Information:
Title
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF])
Description
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.
Time Frame
Baseline (Day 0) and end of treatment (Day 28)
Secondary Outcome Measure Information:
Title
Number of Participants That Were Symptom Free Responders (LOCF)
Description
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 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.
Time Frame
At end of treatment (Day 28)
Title
Participants' Assessment of Pruritus on Trunk and Limbs
Description
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.
Time Frame
At end of treatment (Day 28)
Title
Participants' Overall Assessment of Disease Severity
Description
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.
Time Frame
At end of treatment (Day 28)
Title
Number of Participants That Were Symptom Free Responders by Visit
Description
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.
Time Frame
At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28)
Title
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit
Description
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.
Time Frame
Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sakari Reitamo, MD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Windsor Clinical Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
Facility Name
Klinik und Poliklinik für Dermatologie, Universität Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany

12. IPD Sharing Statement

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LEO 29102 Cream in the Treatment of Atopic Dermatitis

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