Protopic Ointment in Adult Atopic Eczema of the Face - Tabular View

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Protopic Ointment in Adult Atopic Eczema of the Face

This study has been completed.

Study NCT00690105. Last updated on June 3, 2008. Information provided by Astellas Pharma Inc

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Protopic Ointment in Adult Atopic Eczema of the Face

Official Title ^†

Comparative, Multicentre, Randomized, Double-Blind Study to Assess the Efficacy of Tacrolimus 0.1% Ointment Versus Fluticasone 0.005% Ointment in Adult Patients Suffering From Moderate to Severe Atopic Dermatitis and Presenting With so-Called 'Red Face' Lesions of the Head and Neck.

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.

Detailed Description

Treatments were to be applied twice daily over all lesions on the face (except for the eyelids) 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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Assessment of facial pruritus at day 1, day 7 and day 21 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Global assessment of clinical response on the 'face' by the physician at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Global assessment of clinical response on the 'face' by the patient at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Patient's quality of life at day 1 and day 21 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
mLEASI score values at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Physician's assessment of individual signs [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Quality of sleep at day 1, day 7 and day 21 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Affected surface area assessment at day 1, day 7 and day 21 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Number of patients using the ointment from the other group to treat facial lesions after day 21 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Incidences of adverse events during the study period [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Condition ^†

Dermatitis, Atopic

Intervention ^†

Drug: tacrolimus 0.1%
Drug: fluticasone 0.005 %

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

568

Start Date ^†

February 2004

Completion Date

July 2005

Eligibility Criteria ^†

Inclusion Criteria:

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
At least two flare-ups of 'facial' eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment had proved ineffective or poorly tolerated
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
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
Patients who participated at the same time in another clinical study or who had participated in another clinical study within 28 days prior to inclusion in the study
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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Administrative Information Fields

NCT ID ^†

NCT00690105

Organization ID

FG-506-06-FR-04

Secondary IDs ^††

EUDRACT #: 2004-002477-23

Study Sponsor ^†

Astellas Pharma Inc

Collaborators ^††

Investigators ^†

Study Director:

Central Contact

Astellas Pharma Europe BV

Information Provided By

Astellas Pharma Inc

Verification Date

June 2008

First Received Date ^†

June 2, 2008

Last Updated Date

June 3, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.