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

LEO Pharma36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

LEO 29102 creamDRUG

Twice daily application for 7 days

LEO 29102 placebo creamDRUG

LEO 29102 placebo cream

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

PRA International, University Medical Centre

Groningen, Netherlands

Outcomes

Primary Outcomes

Adverse events, laboratory testing, ECG, vital signs

Time frame: Day 9

Secondary Outcomes

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

Time frame: Day 9

Data from ClinicalTrials.gov

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