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

December 21, 2009
October 21, 2013
December 2009
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01037881 on ClinicalTrials.gov Archive Site
  • 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 ]
IGA, change in EASI, IGA, pruritus and patient global assessment over time [ Time Frame: 4 weeks treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
LEO 29102 Cream in the Treatment of Atopic Dermatitis
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: LEO 29102
    comparison of different dosages of drug
  • Drug: Elidel®
    comparison
  • 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®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
183
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Germany,   Canada
 
NCT01037881
LEO 29102-C21, EudraCT Number 2009-013792-22
Yes
LEO Pharma
LEO Pharma
Not Provided
Principal Investigator: Sakari Reitamo, MD Helsinki University Central Hospital
LEO Pharma
April 2012

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