Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: LEO 29102 Cream Vehicle
- Registration Number
- NCT01447758
- Lead Sponsor
- LEO Pharma
- 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 body surface area (BSA) twice daily (BID) for 7 days (Cohorts I, II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation of the safety and tolerability data will assess whether a stepwise increase in the percentage of "to be treated BSA" is justified. Cohort IV will start dosing after finalisation of Cohort II and after submission of data from Cohort I and II to the national authority and IEC for review.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 58
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LEO 29102 2,5 mg/g cream LEO 29102 - LEO 29102 Cream Vehicle LEO 29102 Cream Vehicle -
- Primary Outcome Measures
Name Time Method PK profile - Cohort I, II, III Predose, 1h, 2h, 4h, 6h, 12h, 13h, 14h, 16h, 18h, 24h (on day 1 and 7) and 36h, 48h, 72h (on day 7 only) Cmax, AUC, Tmax
Tolerability and safety of LEO 29102 cream - Cohort I, II, III 14 Days Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination
PK profile - Cohort IV Day 1, 14, 28, 42: Pre AM dose and 1h, 2h, 4h, 6h, 12h. Post AM dose, but prior to PM dose and 24 h, 36h, 48h, 72h after AM dose Day 42 Cmax, AUC, Tmax
Tolerability and safety of LEO 29102 cream - Cohort IV 49 Days Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination, SCORAD, EASI and IGA by stratum, treatment and visit.
- Secondary Outcome Measures
Name Time Method Dermis concentration of LEO 29102 and its metabolites LEO 28386 and LEO 26989 after multiple topical applications in subjects with AD (Cohorts II and IV, Subgroup 1) 10 Days for cohort II; 42 days for cohort IV, subgroup 1 Biomarkers in AD lesions before and after multiple topical applications in subjects with AD (Cohorts I and IV, Subgroup 2) 10 Days for cohort I, 42 days for cohort IV, subgroup 2
Trial Locations
- Locations (8)
Universitätshautklinik Essen
🇩🇪Essen, Germany
Clinical Trial Center North
🇩🇪Hamburg, Germany
Department of Dermatology, Johann Wolfgang Goethe-University
🇩🇪Frankfurt/Main, Germany
SRH Wald-Klinikum Gera gGmbH
🇩🇪Gera, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Klinik und Poliklinik für Dermatologie und Allergologie der Universität Bonn
🇩🇪Bonn, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätshautklinik Münster
🇩🇪Münster, Germany