Health Condition 1: null- Atopic Dermatitis
Conditions
Interventions
Intervention1: Tacrolimus 0.03% and 0.1% Ointment: Daily two time topical application separated by about 12 hours in the morning and night for 21 days
Control Intervention1: Protopic®
(Tacrolimus 0
Sponsors
Biocon Limited
Eligibility
Inclusion criteria
Inclusion criteria: •Male or female patients aged between 2 -75 years •Patients diagnosed with atopic dermatitis as per Hanifin and Rajka diagnostic standards •Patient/parents/guardian is capable of understanding the purposes and risks of the trial and has given written Informed Consent •Patient has documented evidence that they have been unresponsive to alternative traditional therapies such as topical corticosteroids, or in the investigators opinion, such first line therapy would be deemed inadvisable because of potential risks to the patient. •Patients with an IGA score of 3 (moderate) or 4 (severe) at the time of screening •Patients with Eczema Area and Severity Index (EASI) score of at least 15 at the time of screening •Treatment naive patients and/or patients receiving treatments for atopic dermatitis other than tacrolimus can be included in the study after 3 days of wash out period •Female patients of child bearing potential, using double barrier method or use a reliable method of contraception during the study
Exclusion criteria
Exclusion criteria: •Patient has clinically infected atopic dermatitis at baseline •Patient with known hypersensitivity to macrolides in general, to tacrolimus or any excipients of the ointment •Any dermatological condition other than atopic dermatitis that in the Investigators opinion may interfere with the evaluation of the patients atopic dermatitis •Patients using non-sedating anti-histamines 7 days prior to the first dosing day or at any point during the study •Current diagnosis or history or any disease, which in the Investigators opinion would contraindicate the use of immunosuppressantâ??s, including but not limited to human immunodeficiency virus (HIV) and cancer. •Females who are pregnant, lactating or likely to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in Investigators Global Assessment (IGA) scale from baseline with Tacrolimus 0.03% and 0.1% ointment (Bioconâ??s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatmentTimepoint: 21 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in Eczema Area and Severity Index (EASI) score from baseline with Tacrolimus ointment 0.03% and 0.1% (Bioconâ??s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatmentTimepoint: 21 days of treatment;Percentage of patients showing greater than or equal to 60% improvement in EASI scale from baseline with Tacrolimus 0.03% and 0.1% ointment (Bioconâ??s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatmentTimepoint: 21 days of treatment;Percentage of patients showing greater than or equal to 60% improvement in IGA scale from baseline with Tacrolimus 0.03% and 0.1% ointment (Bioconâ??s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatmentTimepoint: 21 days of treatment | — |
Countries
India
Contacts
Public ContactDr Vanita Sabhahit
Biocon Limited
Outcome results
None listed