Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00944632
First received: July 22, 2009
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: ZK 245186
Drug: Placebo (vehicle ointment)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator's Global Assessment of target area [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zk 245186 0.01% ointment
Active treatment, lowest dose
Drug: ZK 245186
Once daily topical non-occlusive application for up to 4 weeks
Active Comparator: ZK 245186 0.03% ointment
Active comparator middle dose
Drug: ZK 245186
Once daily topical non-occlusive application for up to 4 weeks
Active Comparator: ZK 245186 0.1% ointment
Active comparator highest dose
Drug: ZK 245186
Once daily topical non-occlusive application for up to 4 weeks
Placebo Comparator: Vehicle ointment
Placebo comparator
Drug: Placebo (vehicle ointment)
Once daily topical non-occlusive application for up to 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944632

Locations
South Africa
Bloemfontein, South Africa, 9301
George, South Africa, 6529
Newton Park, South Africa, 6045
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00944632     History of Changes
Other Study ID Numbers: 14501, 1402942
Study First Received: July 22, 2009
Last Updated: February 19, 2014
Health Authority: South Africa: Department of Health

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014