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A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

LEO 29102 cream

LEO 29102 placebo cream

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-55 years
Atopic dermatitis of 850-1700cm2
In good health

Criteria for exclusion:

Co-morbid conditions
Hepatic dysfunction
Clinical infection
Immunocompromised status
Clinically significant illness
Use of immunomodulating treatment
Medications related to respiratory system or to heart rhythm

Sites / Locations

PRA International, University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

LEO 29102 cream 0.3 mg/g

LEO 29102 cream 1.0 mg/g

LEO 29102 cream 2.5 mg/g

LEO 29102 placebo cream

Arm Description

Outcomes

Primary Outcome Measures

Adverse events, laboratory testing, ECG, vital signs

Secondary Outcome Measures

To assess the efficacy of LEO 29102 cream in the treatment of AD

Full Information

NCT ID

NCT01005823

First Posted

October 23, 2009

Last Updated

October 21, 2013

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01005823

Brief Title

A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis

Official Title

A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7 days treatment with LEO 29102 in adult patients with atopic dermatitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LEO 29102 cream 0.3 mg/g

Arm Type

Active Comparator

Arm Title

LEO 29102 cream 1.0 mg/g

Arm Type

Active Comparator

Arm Title

LEO 29102 cream 2.5 mg/g

Arm Type

Active Comparator

Arm Title

LEO 29102 placebo cream

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

LEO 29102 cream

Intervention Description

Twice daily application for 7 days

Intervention Type

Drug

Intervention Name(s)

LEO 29102 placebo cream

Intervention Description

LEO 29102 placebo cream

Primary Outcome Measure Information:

Title

Adverse events, laboratory testing, ECG, vital signs

Time Frame

Day 9

Secondary Outcome Measure Information:

Title

To assess the efficacy of LEO 29102 cream in the treatment of AD

Time Frame

Day 9

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-55 years Atopic dermatitis of 850-1700cm2 In good health Criteria for exclusion: Co-morbid conditions Hepatic dysfunction Clinical infection Immunocompromised status Clinically significant illness Use of immunomodulating treatment Medications related to respiratory system or to heart rhythm

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kahlid Aboufarha

Organizational Affiliation

PRA Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

PRA International, University Medical Centre

City

Groningen

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis

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