NCT00689832

Brief Summary

Children with 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
487

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
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2.8 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

1.5 years

First QC Date

June 2, 2008

Last Update Submit

August 28, 2014

Conditions

Dermatitis, Atopic

Keywords

Dermatitis, AtopicDermatologic AgentsTopical Drug AdministrationTacrolimusCalcineurinCorticosteroidFluticasone propionateChild

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 modified Eczema Area and Severity Index (mEASI) in comparison to day 1

    3 weeks

Secondary Outcomes (7)

  • mEASI and EASI scores at each visit and percentage change with respect to day 1

    1 week and 3 weeks

  • Global assessment of clinical response by the physician at each visit after day 1

    1 week and 3 weeks

  • Global assessment of clinical response by the patient/parents at each visit after day 1

    1 week and 3 weeks

  • All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit

    1 week and 3 weeks

  • Compliance with the treatment assessed from the patient's diary

    1 week and 3 weeks

  • +2 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: Tacrolimus 0.03%

B

ACTIVE COMPARATOR
Drug: Fluticasone 0.005%

Interventions

Tacrolimus 0.03%DRUG

ointment

Also known as: Protopic® 0.03%
A
Fluticasone 0.005%DRUG

ointment

Also known as: Flixovate® 0.005%
B

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with moderate to severe atopic dermatitis (Rajka \& Langeland score greater than or equal to 4.5) and who had responded insufficiently to conventional therapies
  • 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
  • Any female patients who were pregnant or breast-feeding
  • 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 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
  • Patients participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study
  • substance abuse (including that of drugs and alcohol) or mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
  • Known serologically proven HIV positivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Paris, 75015, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

  • 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

August 1, 2005

Study Completion

August 1, 2005

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

FR(1)