Protopic Ointment in Children Atopic Eczema
Phase 4
Completed
- Conditions
- Dermatitis, Atopic
- Interventions
- Registration Number
- NCT00689832
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 487
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Tacrolimus 0.03% - 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 modified Eczema Area and Severity Index (mEASI) in comparison to day 1 3 weeks
- Secondary Outcome Measures
Name Time Method mEASI and EASI scores at each visit and percentage change with respect to day 1 1 week and 3 weeks 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 Compliance with the treatment assessed from the patient's diary 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