Moderate to severe atopic dermatitis MedDRA version: 7.0 Level: LLT Classification code 10003639
Conditions
Interventions
Trade Name: Protopic 0.03% ointment
Product Name: Protopic
Product Code: FK506
Pharmaceutical Form: Ointment
INN or Proposed INN: Tacrolimus
CAS Number: 104987-11-3
Current Sponsor code: FK506
Concent
Sponsors
Fujisawa GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only those patients complying with the criteria below may be included: -Male or female patients, of any racial origin, -Patients aged between 2 and 15 years (not yet celebrated their 16th birthday) suffering from moderate to severe atopic dermatitis (Rajka & Langeland score = 4.5 – see Annex C) and who have responded insufficiently to conventional therapies. -Female patients of childbearing age must undertake to use, if relevant, effective contraceptive measures throughout the period of the study and for the four weeks following the end of the study. -Children whose parents have signed the informed consent form. In this case, and if the child is capable of understanding the aims and risks inherent in the study, his or her written informed consent should also be obtained. -Patients complying with the following criteria for therapeutic washout: Treatment restrictions prior to the study: Washout period before Day 1 Topical corticosteroids: 3 days Systemic corticosteroids for the treatment of atopic dermatitis: 5 days Non-steroidal immunosuppressants (cyclosporin, methotrexate, etc.): 2 weeks Systemic antihistamines: 5 days Other study drugs: 4 weeks UVA/UVB therapy: 4 weeks Treatment with Tacrolimus ointment or Pimecrolimus: 2 weeks Topical antibiotics: 3 days Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients presenting with any one of the following criteria cannot be included in the study: -Patients with a genetic epidermal barrier defect, such as Netherton's syndrome, or those suffering from erythroderma. -Any female patients who are pregnant or breast-feeding. -Patients presenting with a clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum. -Patients presenting with superinfected eczema. -Patients presenting with known hypersensitivity to macrolides or to any other excipient in tacrolimus ointment. -Patients presenting with known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation. -Patients presenting with ulcerated lesions, of whatever type. -Patients presenting with moderate to severe acne with 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. -Patients presenting with any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, may interfere with the patient's follow-up. -Patients with known serologically-proven HIV positivity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to compare the efficacy and safety of tacrolimus 0.03% ointment versus fluticasone 0.005% ointment, administered in accordance with the conditions of their respective marketing authorisations.;Secondary Objective: ;Primary end point(s): Efficacy will be judged from the mEASI score (modified Eczema Area and Severity Index, described in Annex C), assessed at week 3 (D21), the primary endpoint being the number of patients presenting with a 60% improvement in their mEASI score at week 3, versus D1. | — |
Countries
Finland
Outcome results
None listed