Clinical trial NCT00690105: Protopic Ointment in Adult Atopic Eczema of the Face
Official title: Comparative, Multicentre, Randomized, Double-blind Study to Assess the Efficacy of Tacrolimus 0.1% Ointment Versus Fluticasone 0.005% Ointment in Adult Patients Suffering From Moderate to Severe Atopic Dermatitis and Presenting With So-called 'Red Face' Lesions of the Head and Neck.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Atopic
Keywords: Dermatitis, Atopic
Dermatologic Agents
Topical Drug Administration
Tacrolimus
Calcineurin
Corticosteroid
Fluticasone propionate
Face
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 577
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: 3 weeks
Secondary outcomes:
measure: Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21
timeFrame: 1 week and 3 weeks
measure: Assessment of facial pruritus at day 1, day 7 and day 21
timeFrame: 1 week and 3 weeks
measure: Global assessment of clinical response on the 'face' by the physician at day 7 and day 21
timeFrame: 1 week and 3 weeks
measure: Global assessment of clinical response on the 'face' by the patient at day 7 and day 21
timeFrame: 1 week and 3 weeks
measure: Patient's quality of life at day 1 and day 21
timeFrame: 1 week and 3 weeks
measure: mLEASI score values at day 7 and day 21
timeFrame: 1 week and 3 weeks
measure: Physician's assessment of individual signs
timeFrame: 1 week and 3 weeks
measure: Quality of sleep at day 1, day 7 and day 21
timeFrame: 1 week and 3 weeks
measure: Affected surface area assessment at day 1, day 7 and day 21
timeFrame: 1 week and 3 weeks
measure: Number of patients using the ointment from the other group to treat facial lesions after day 21
timeFrame: 3 weeks
measure: Incidences of adverse events during the study period
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Nice
country: France
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_DIRECTOR
References: