Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.

Atopic Dermatitis Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01447758
• Other study ID #: LEO 29102-C26
• Status: Terminated
• Phase: Phase 1
• First received: July 13, 2011
• Last updated: April 30, 2013
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• LEO 29102
Cream, 1,7mg/cm2 BSA, BID, 7 days In Cohort I, II and III, 6 weeks in Cohort IV
• LEO 29102 Cream Vehicle
Cream, 1,7mg/cm2 BSA, BID, 7 days in Cohort I and II, 6 weeks in Cohort IV

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Klinik und Poliklinik für Dermatologie und Allergologie der Universität Bonn	Bonn
Germany	Universitätshautklinik Essen	Essen
Germany	Department of Dermatology, Johann Wolfgang Goethe-University	Frankfurt/Main
Germany	SRH Wald-Klinikum Gera gGmbH	Gera
Germany	Clinical Trial Center North	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätshautklinik Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK profile - Cohort I, II, III	Cmax, AUC, Tmax	Predose, 1h, 2h, 4h, 6h, 12h, 13h, 14h, 16h, 18h, 24h (on day 1 and 7) and 36h, 48h, 72h (on day 7 only)	No
Primary	Tolerability and safety of LEO 29102 cream - Cohort I, II, III	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	14 Days	Yes
Primary	PK profile - Cohort IV	Cmax, AUC, Tmax	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	No
Primary	Tolerability and safety of LEO 29102 cream - Cohort IV	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.	49 Days	Yes
Secondary	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	No
Secondary	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	No