NCT00690105

Brief Summary

Patients with facial atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed or change for the other ointment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
577

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

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

February 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

June 2, 2008

Last Update Submit

August 28, 2014

Conditions

Dermatitis, Atopic

Keywords

Dermatitis, AtopicDermatologic AgentsTopical Drug AdministrationTacrolimusCalcineurinCorticosteroidFluticasone propionateFace

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their local mEASI score (mLEASI) compared to Baseline (day 1).

    3 weeks

Secondary Outcomes (11)

  • Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21

    1 week and 3 weeks

  • Assessment of facial pruritus at day 1, day 7 and day 21

    1 week and 3 weeks

  • Global assessment of clinical response on the 'face' by the physician at day 7 and day 21

    1 week and 3 weeks

  • Global assessment of clinical response on the 'face' by the patient at day 7 and day 21

    1 week and 3 weeks

  • Patient's quality of life at day 1 and day 21

    1 week and 3 weeks

  • +6 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: tacrolimus 0.1%

B

ACTIVE COMPARATOR
Drug: fluticasone 0.005 %

Interventions

tacrolimus 0.1%DRUG

ointment

Also known as: Protopic® 0.1%
A
fluticasone 0.005 %DRUG

ointment

Also known as: Flixovate® 0.005%
B

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe AD (Rajka \& Langeland score) with lesions to the head and neck defined as 'red face' or 'facial eczema': erythema affecting at least 10% of the surface of the 'face' (head, neck, chest, nape of neck), due to long-term AD
  • Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
  • Informed consent
  • Therapeutic washout for atopic dermatitis treatments

You may not qualify if:

  • Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
  • Seborrheic dermatitis or contact dermatitis affecting the 'face', or any other facial erythema of non-atopic origin
  • Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
  • Superinfected eczema
  • Known hypersensitivity to macrolides or to any other excipient in tacrolimus 0.1% ointment
  • Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation
  • Ulcerated lesions, of whatever type
  • Moderate to severe acne or rosacea
  • Any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
  • Serologically-proven HIV positivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Nice, 06202, France

Location

MeSH Terms

Conditions

Dermatitis, AtopicFacies

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Central Contact

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 4, 2008

Study Start

February 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

FR(1)