NCT01408511

Brief Summary

A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2011

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 19, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2011

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2011

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

August 1, 2011

Last Update Submit

October 30, 2023

Conditions

Atopic DermatitisEczema

Outcome Measures

Primary Outcomes (1)

  • HPA axis response to Cosyntropin: Number of subjects with adrenal suppression

    measured after 4 weeks of therapy

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Mapracorat

Interventions

MapracoratDRUG

Application of the investigational product on the affected skin areas

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent
  • Male or female subject aged \>= 18 years
  • Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
  • Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline
  • Normal ACTH response before start of treatment

You may not qualify if:

  • Pregnancy or lactation
  • Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
  • Concomitant medical or dermatological disorder(s), which could interfere with the study conduct or the evaluation and interpretation of the study results
  • Clinically manifest immunosuppressive disorder or known history of malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

PAREXEL Bloemfontein

Bloemfontein, South Africa

Location

PAREXEL George

George, South Africa

Location

PAREXEL Port Elizabeth

Port Elizabeth, South Africa

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczema

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2011

First Posted

August 3, 2011

Study Start

July 19, 2011

Primary Completion

December 15, 2011

Study Completion

December 21, 2011

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

ZA(3)