| June 2, 2008 |
| December 4, 2008 |
| February 2004 |
| July 2005 (final data collection date for primary outcome 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). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00690105 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Protopic Ointment in Adult Atopic Eczema of the Face |
| 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. |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Dermatitis, Atopic |
- Drug: tacrolimus 0.1%
- Drug: fluticasone 0.005 %
|
| |
| |
| |
| Completed |
| 577 |
| July 2005 |
| July 2005 (final data collection date for primary outcome measure) |
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
|
| Both |
| 16 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| France |
| |
| NCT00690105 |
| Disclosure Office Europe, Astellas Pharma Europe BV |
| FG-506-06-FR-04, EUDRACT #: 2004-002477-23 |
| Astellas Pharma Inc |
|
| Study Director: |
Central Contact |
Astellas Pharma Europe BV |
|
|
| Astellas Pharma Inc |
| December 2008 |