Protopic Ointment in Adult Atopic Eczema of the Face

Astellas

Status and phase

Completed

Phase 4

Conditions

Dermatitis, Atopic

Treatments

Drug: tacrolimus 0.1%

Drug: fluticasone 0.005 %

Study type

Interventional

Funder types

Industry

Identifiers

NCT00690105

EUDRACT #: 2004-002477-23

FG-506-06-FR-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

577 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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