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Completed

NCT Number: NCT01005823

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA International, University Medical Centre

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEO 29102 cream

Drug

Twice daily application for 7 days

LEO 29102 placebo cream

Drug

LEO 29102 placebo cream

Primary outcomes

  1. Adverse events, laboratory testing, ECG, vital signs

    Time frame: Day 9

Secondary outcomes

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

    Time frame: Day 9

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 2, 2009
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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