Status:
TERMINATED
Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.
Lead Sponsor:
LEO Pharma
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this Phase Ib study is to investigate the safety, tolerability and pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions from 10 up to 100% of the bo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Clinical diagnosis of AD defined according to Hanifin and Rajka.
- Investigator Global Assessment scored as mild (2) to severe (4) AD.
- At screening, AD lesions amenable for treatment involving 10% to \< 25% (Cohort I), 25% to \< 50% (Cohort II), 50% to 100% (Cohort III) and 10% to \< 50% (Cohort IV) of the total BSA.
- On Day -1, AD lesions amenable for treatment involving 10% to \< 28% (Cohort I), 25% to \< 55% (Cohort II), 50% to 100% (Cohort III) and 10% to \< 55% (Cohort IV) of the total BSA.
- Adult male or female subjects, aged 18 to 65 years, inclusive.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01447758
Start Date
September 1 2011
End Date
March 1 2013
Last Update
February 24 2025
Active Locations (8)
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1
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
2
Klinik und Poliklinik für Dermatologie und Allergologie der Universität Bonn
Bonn, Germany, 53105
3
Universitätshautklinik Essen
Essen, Germany, 45122
4
Department of Dermatology, Johann Wolfgang Goethe-University
Frankfurt am Main, Germany, 60590