Atopic Dermatitis MedDRA version: 7.0 Level: LLT Classification code 10003639
Conditions
Interventions
Trade Name: Protopic
Product Name: Protopic
Product Code: FK506
Pharmaceutical Form: Ointment
INN or Proposed INN: Tacrolimus
CAS Number: 104987-11-3
Current Sponsor code: FK506
Concentration unit: %
Sponsors
Fujisawa GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient may be male or female of any ethnic group. 2) Patient is aged 2 to 15 years and suffers from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3). 3) Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well 4) Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study. 5) Patient meets the following wash-out criteria at Open Label Day 1 visit: Pre-Study Therapy Restrictions - Topical corticosteroids, topical immunomodulators (except for intranasal/inhaled corticosteroids) = 3 days wash-out period prior to Open Label Day 1 - Systemic corticosteroids (for the treatment of AD only) = 5 days wash-out period prior to Open Label Day 1 - Systemic non-steroidal immunosuppressants (e.g. ciclosporine, methotrexate) = 2 weeks wash-out period prior to Open Label Day 1 - Other investigational drugs = 4 weeks wash-out period prior to Open Label Day 1 - Light Treatments (UVA, UVB) = 6 weeks wash-out period prior to Open Label Day 1 6) Patient and legal representative(s) agree that the patient will not take for the complete study period any medication or therapy prohibited by the protocol, 7) Patient is able to reach the centre within 2 days in case of a disease exacerbation. 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: 1) Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma. 2) Patient is pregnant or breast-feeding. 3) Patient has a clinically significant skin infection on the affected (and to be treated) area. 4) Patient has a known hypersensitivity to macrolides or any excipient of the ointment. 5) Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one. 6) Any form of substance abuse (including drug or alcohol abuse) psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the communication with the investigator. 7) Patient is known to be HIV positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to compare the efficacy and safety of a tacrolimus ointment 0.03% regimen to a vehicle-based regimen administered to control atopic dermatitis in paediatric patients over a period of 12 months.;Secondary Objective: ;Primary end point(s): Number of disease exacerbations requiring a “substantial therapeutic intervention” during the disease control period. A “substantial therapeutic intervention” is defined as an exacerbation treatment of > 7 days scheduled relative to Exacerbation Day 1 visit and an IGA 3-5 at Exacerbation Day 1 visit. | — |
Countries
Hungary
Outcome results
None listed