Protopic Ointment in Adult Atopic Eczema of the Face
Phase 4
Completed
- Conditions
- Dermatitis, Atopic
- Interventions
- Registration Number
- NCT00690105
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 577
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A tacrolimus 0.1% - B fluticasone 0.005 % -
- Primary Outcome Measures
Name Time Method Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their local mEASI score (mLEASI) compared to Baseline (day 1). 3 weeks
- Secondary Outcome Measures
Name Time Method Assessment of facial pruritus at day 1, day 7 and day 21 1 week and 3 weeks Number of patients using the ointment from the other group to treat facial lesions after day 21 3 weeks Incidences of adverse events during the study period 6 weeks Patient's quality of life at day 1 and day 21 1 week and 3 weeks Quality of sleep at day 1, day 7 and day 21 1 week and 3 weeks Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21 1 week and 3 weeks Global assessment of clinical response on the 'face' by the physician at day 7 and day 21 1 week and 3 weeks Global assessment of clinical response on the 'face' by the patient at day 7 and day 21 1 week and 3 weeks mLEASI score values at day 7 and day 21 1 week and 3 weeks Physician's assessment of individual signs 1 week and 3 weeks Affected surface area assessment at day 1, day 7 and day 21 1 week and 3 weeks