Dermatitis, Atopic
Conditions
Keywords
Dermatitis, Atopic, Dermatologic Agents, Topical Drug Administration, Tacrolimus, Calcineurin, Corticosteroid, Fluticasone propionate, Child
Brief summary
Children with 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.
Detailed description
Treatments were to be applied twice daily 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. Statistical methods: An interim analysis was performed on 30% of the planned total sample size, i.e. 140 included patients who had completed the study, to reassess the assumptions made during the planning phase.
Interventions
DRUGTacrolimus 0.03%
ointment
DRUGFluticasone 0.005%
ointment
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Children with moderate to severe atopic dermatitis (Rajka & Langeland score greater than or equal to 4.5) and who had responded insufficiently to conventional therapies * 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 * Any female patients who were pregnant or breast-feeding * 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 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 participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study * substance abuse (including that of drugs and alcohol) or mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up * Known serologically proven HIV positivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their modified Eczema Area and Severity Index (mEASI) in comparison to day 1 | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Global assessment of clinical response by the physician at each visit after day 1 | 1 week and 3 weeks |
| Global assessment of clinical response by the patient/parents at each visit after day 1 | 1 week and 3 weeks |
| All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit | 1 week and 3 weeks |
| mEASI and EASI scores at each visit and percentage change with respect to day 1 | 1 week and 3 weeks |
| Patient's quality of life assessed at day 1 and day 21 | 3 weeks |
| Incidence of adverse events during the study | 6 weeks |
| Compliance with the treatment assessed from the patient's diary | 1 week and 3 weeks |
Countries
France
Outcome results
None listed