Clinical trial NCT01447758: Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.
Official title: Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis. A Multicentre, Prospective, Randomised Phase Ib Study in Subjects Investigating Safety,Tolerability and Pharmacokinetics of LEO 29102 Cream (2.5 mg/g) When Treating Atopic Dermatitis Lesions Twice Daily for 7 Days (Cohorts I, II and III) and 6 Weeks (Cohort IV)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2011-10-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of AD defined according to Hanifin and Rajka.
2. Investigator Global Assessment scored as mild (2) to severe (4) AD.
3. 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.
4. 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.
5. Adult male or female subjects, aged 18 to 65 years, inclusive.

Primary outcomes:
measure: PK profile - Cohort I, II, III
timeFrame: Predose, 1h, 2h, 4h, 6h, 12h, 13h, 14h, 16h, 18h, 24h (on day 1 and 7) and 36h, 48h, 72h (on day 7 only)
measure: Tolerability and safety of LEO 29102 cream - Cohort I, II, III
timeFrame: 14 Days
measure: PK profile - Cohort IV
timeFrame: 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
measure: Tolerability and safety of LEO 29102 cream - Cohort IV
timeFrame: 49 Days
Secondary outcomes:
measure: 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)
timeFrame: 10 Days for cohort II; 42 days for cohort IV, subgroup 1
measure: Biomarkers in AD lesions before and after multiple topical applications in subjects with AD (Cohorts I and IV, Subgroup 2)
timeFrame: 10 Days for cohort I, 42 days for cohort IV, subgroup 2
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Klinik und Poliklinik für Dermatologie und Allergologie der Universität Bonn
city: Essen
country: Germany
facility: Universitätshautklinik Essen
city: Frankfurt/Main
country: Germany
facility: Department of Dermatology, Johann Wolfgang Goethe-University
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera gGmbH
city: Hamburg
country: Germany
facility: Clinical Trial Center North
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Münster
country: Germany
facility: Universitätshautklinik Münster
Study officials:
affiliation: Goethe University
name: Diamant Thaci, MD
role: PRINCIPAL_INVESTIGATOR
References: