Protopic Ointment in Adult Atopic Eczema of the Face

NCT ID: NCT00690105

Last Updated: 2014-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 577 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2005-07-31

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.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Group Type: EXPERIMENTAL

tacrolimus 0.1%

Intervention Type: DRUG

ointment

B

Group Type: ACTIVE_COMPARATOR

fluticasone 0.005 %

Intervention Type: DRUG

ointment

Interventions

tacrolimus 0.1%

ointment

Intervention Type: DRUG

fluticasone 0.005 %

ointment

Intervention Type: DRUG

Other Intervention Names

Protopic® 0.1%; Flixovate® 0.005%

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

Nice, , France

Countries

France

Other Identifiers

EUDRACT #: 2004-002477-23

Identifier Type: -

Identifier Source: secondary_id

FG-506-06-FR-04

Identifier Type: -

Identifier Source: org_study_id