NCT00944632

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2010

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

July 22, 2009

Last Update Submit

June 5, 2023

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

    up to 4 weeks

Secondary Outcomes (1)

  • Investigator's Global Assessment of target area

    up to 4 weeks

Study Arms (4)

Zk 245186 0.01% ointment

ACTIVE COMPARATOR

Active treatment, lowest dose

Drug: ZK 245186

ZK 245186 0.03% ointment

ACTIVE COMPARATOR

Active comparator middle dose

Drug: ZK 245186

ZK 245186 0.1% ointment

ACTIVE COMPARATOR

Active comparator highest dose

Drug: ZK 245186

Vehicle ointment

PLACEBO COMPARATOR

Placebo comparator

Drug: Placebo (vehicle ointment)

Interventions

ZK 245186DRUG

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

ZK 245186 0.03% ointmentZK 245186 0.1% ointmentZk 245186 0.01% ointment
Placebo (vehicle ointment)DRUG

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

Vehicle ointment

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

PAREXEL International (Bloemfontein)

Bloemfontein, 9301, South Africa

Location

PAREXEL International (George)

George, 6529, South Africa

Location

PAREXEL International (Port Elizabeth)

Newton Park, 6045, South Africa

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 23, 2009

Study Start

July 15, 2009

Primary Completion

September 15, 2010

Study Completion

September 15, 2010

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations

ZA(3)