Protopic Ointment in Adult Atopic Eczema of the Face

• 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 ]

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.

• Drug: tacrolimus 0.1%
  ointment
  Other Name: Protopic® 0.1%
• Drug: fluticasone 0.005 %
  ointment
  Other Name: Flixovate® 0.005%

• Experimental: A
  Intervention: Drug: tacrolimus 0.1%
• Active Comparator: B
  Intervention: Drug: fluticasone 0.005 %

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