Protopic Ointment in Children Atopic Eczema | NCT00689832

Studies
Protopic Ointment in Children Atopic Eczema

NCT00689832

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Sep 1, 2014Estimated

Enrollment

487Actual

Phase

Phase 4

Conditions

Dermatitis, Atopic

Interventions

Tacrolimus 0.03%
Fluticasone 0.005%

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EUDRACT #:2004-002478-47

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Aug 2005Actual

Completion Date

Aug 2005Actual

First Submitted Date

Jun 2, 2008

First Submission Date that Met QC Criteria

Jun 3, 2008

First Posted Date

Jun 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2014

Last Update Posted Date

Sep 1, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Treatments were to be applied twice daily until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.

Statistical methods: An interim analysis was performed on 30% of the planned total sample size, i.e. 140 included patients who had completed the study, to reassess the assumptions made during the planning phase.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

487Actual

Label	Type	Description	Intervention Names
A	Experimental		Drug: Tacrolimus 0.03%
B	Active Comparator		Drug: Fluticasone 0.005%

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus 0.03%	Drug	ointment	A	Protopic® 0.03%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Central Contact	Astellas Pharma Europe B.V.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

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