LEO 29102 Cream in the Treatment of Atopic Dermatitis

This study has been completed.

Sponsor:

Information provided by:

LEO Pharma

ClinicalTrials.gov Identifier:

NCT01037881

First received: December 21, 2009

Last updated: April 12, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2009

Last Updated Date

April 12, 2012

Start Date ^ICMJE

December 2009

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01037881 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

IGA, change in EASI, IGA, pruritus and patient global assessment over time [ Time Frame: 4 weeks treatment ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

LEO 29102 Cream in the Treatment of Atopic Dermatitis

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Drug: LEO 29102
comparison of different dosages of drug
Drug: Elidel®
comparison

Study Arm (s)

Experimental: LEO 29102 0.03 mg/g cream
Intervention: Drug: LEO 29102
Experimental: LEO 29102 0.1 mg/g cream
Intervention: Drug: LEO 29102
Experimental: LEO 29102 0.3 mg/g cream
Intervention: Drug: LEO 29102
Experimental: LEO 29102 1.0 mg/g cream
Intervention: Drug: LEO 29102
Experimental: LEO 29102 2.5 mg/g cream
Intervention: Drug: LEO 29102
Placebo Comparator: LEO 29102 cream vehicle
Intervention: Drug: LEO 29102
Active Comparator: Elidel® cream (pimecrolimus) 10 mg/g
Intervention: Drug: Elidel®

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

183

Completion Date

June 2010

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada, Finland, Germany

Administrative Information

NCT Number ^ICMJE

NCT01037881

Other Study ID Numbers ^ICMJE

LEO 29102-C21, EudraCT Number 2009-013792-22

Has Data Monitoring Committee

Yes

Responsible Party

Johan Quensel / Principal Clinical Project Manager, LEO Pharma

Study Sponsor ^ICMJE

LEO Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sakari Reitamo, MD

Helsinki University Central Hospital

Information Provided By

LEO Pharma

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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