LEO 29102 Cream in the Treatment of Atopic Dermatitis

NCT01037881 | Completed Phase 2 Results DMC

• 2 other identifiers: LEO 29102-C21EudraCT Number 2009-013792-22
• Study Type: interventional
• Target: 183
• Locations: 3 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 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.

  Baseline (Day 0) and end of treatment (Day 28)

Secondary Outcomes (5)

• Number of Participants That Were Symptom Free Responders (LOCF)

  At end of treatment (Day 28)

• Participants' Assessment of Pruritus on Trunk and Limbs

  At end of treatment (Day 28)

• Participants' Overall Assessment of Disease Severity

  At end of treatment (Day 28)

• Number of Participants That Were Symptom Free Responders by Visit

  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

  Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21)

Study Arms (7)

LEO 29102 0.03 mg/g cream

EXPERIMENTAL

Drug: LEO 29102

LEO 29102 0.1 mg/g cream

EXPERIMENTAL

Drug: LEO 29102

LEO 29102 0.3 mg/g cream

EXPERIMENTAL

Drug: LEO 29102

LEO 29102 1.0 mg/g cream

EXPERIMENTAL

Drug: LEO 29102

LEO 29102 2.5 mg/g cream

EXPERIMENTAL

Drug: LEO 29102

LEO 29102 cream vehicle

PLACEBO COMPARATOR

Drug: LEO 29102

Elidel® cream (pimecrolimus) 10 mg/g

ACTIVE COMPARATOR

Drug: Elidel®

Interventions

LEO 29102 DRUG

comparison of different dosages of drug

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® DRUG

comparison

Elidel® cream (pimecrolimus) 10 mg/g

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (3)

Windsor Clinical Research Inc.

Windsor, Ontario, N8W 5L7, Canada

Location

Helsinki University Central Hospital

Helsinki, 00250, Finland

Location

Klinik und Poliklinik für Dermatologie, Universität Bonn

Bonn, 53105, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

2-(6-(2-(3,5-dichloro-4-pyridyl)acetyl)-2,3-dimethoxyphenoxy)-N-propylacetamide; pimecrolimus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2009
• First Posted: December 23, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 10, 2025
• Results First Posted: October 14, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); CA (1); DE (1)