Status:
COMPLETED
Protopic Ointment in Children Atopic Eczema
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
2-15 years
Phase:
PHASE4
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...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
487 Patients enrolled
Trial Details
Trial ID
NCT00689832
Start Date
February 1 2004
End Date
August 1 2005
Last Update
September 1 2014
Active Locations (1)
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1
Paris, France, 75015