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LEO 29102 Cream in the Treatment of Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01037881
First received: December 21, 2009
Last updated: October 21, 2013
Last verified: April 2012
  Purpose

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 Intervention Phase
Atopic Dermatitis
Drug: LEO 29102
Drug: Elidel®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Change in eczema area and severity index (EASI) score from baseline to end of treatment [ Time Frame: 4 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in EASI [ Time Frame: 4 weeks treatment ] [ Designated as safety issue: No ]
  • Change in IGA [ Time Frame: 4 weeks treatment ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: December 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037881

Locations
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
Principal Investigator: Sakari Reitamo, MD Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01037881     History of Changes
Other Study ID Numbers: LEO 29102-C21, EudraCT Number 2009-013792-22
Study First Received: December 21, 2009
Last Updated: October 21, 2013
Health Authority: Canada: Health Canada
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 24, 2014