Protopic Ointment in Adult Atopic Eczema of the Face
Protopic Ointment in Adult Atopic Eczema of the Face
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.
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.
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