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

NCT ID: NCT01447758

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-03-31

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LEO 29102 2,5 mg/g cream

Group Type: EXPERIMENTAL

LEO 29102

Intervention Type: DRUG

Cream, 1,7mg/cm2 BSA, BID, 7 days In Cohort I, II and III, 6 weeks in Cohort IV

LEO 29102 Cream Vehicle

Group Type: PLACEBO_COMPARATOR

LEO 29102 Cream Vehicle

Intervention Type: DRUG

Cream, 1,7mg/cm2 BSA, BID, 7 days in Cohort I and II, 6 weeks in Cohort IV

Interventions

LEO 29102

Cream, 1,7mg/cm2 BSA, BID, 7 days In Cohort I, II and III, 6 weeks in Cohort IV

Intervention Type: DRUG

LEO 29102 Cream Vehicle

Cream, 1,7mg/cm2 BSA, BID, 7 days in Cohort I and II, 6 weeks in Cohort IV

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diamant Thaci, MD

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Locations

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 am Main, , Germany

SRH Wald-Klinikum Gera gGmbH

Gera, , Germany

Clinical Trial Center North

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitätshautklinik Münster

Münster, , Germany

Countries

Germany

Other Identifiers

LEO 29102-C26

Identifier Type: -

Identifier Source: org_study_id