Protopic Ointment in Adult Atopic Eczema of the Face

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Fluticasone; Tacrolimus

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