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OpenTrials
Completed

NCT Number: NCT00944632

Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

The purpose of this study is to determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.

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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 2

Primary location

PAREXEL International (Bloemfontein), Bloemfontein, South Africa

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of atopic dermatitis (Hanifin and Rajka criteria)
  • mild to moderate atopic dermatitis at beginning of study
  • wash-out periods for systemic and topical treatments for atopic dermatitis
  • females must use effective contraception

Exclusion criteria

  • pregnant or lactating women
  • conditions that in the opinion of the investigator may pose a risk or interfere with the evaluation of the study
  • wide-spread atopic dermatitis requiring systemic treatment
  • diagnosed with immunocompromised status
  • skin diseases - other than atopic dermatitis - in the treatment area
  • mental handicap or legally incompetent

Treatment and study plan

ZK 245186

Drug

Once daily topical non-occlusive application for up to 4 weeks

placebo (vehicle ointment)

Drug

Once daily topical non-occlusive application for up to 4 weeks

Primary outcomes

  1. Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation

    Time frame: up to 4 weeks

Secondary outcomes

  1. Investigator's Global Assessment of target area

    Time frame: up to 4 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Double-blind, Randomized, Dose Escalation Study of the Efficacy and Safety of ZK 245186 Ointment in Concentrations of 0.01%, 0.03%, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 23, 2009
Registry last updated
Jun 7, 2023

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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