Status:
COMPLETED
Protopic Ointment in Adult Atopic Eczema of the Face
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
16+ years
Phase:
PHASE4
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...
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
577 Patients enrolled
Trial Details
Trial ID
NCT00690105
Start Date
February 1 2004
End Date
July 1 2005
Last Update
September 1 2014
Active Locations (1)
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1
Nice, France, 06202