A Clinical Study on Treatment of Tacrolimus (0.03% and 0.1%) Topical Ointment Versus Protopic(0.03% and 0.1%)Topical Ointment in multiple hospitals randomly distributed Atopic Dermatitis in Children and Adults patient population in India
- Conditions
- Atopic Dermatitis
- Registration Number
- CTRI/2011/12/002237
- Lead Sponsor
- Biocon Limited
- Brief Summary
The study will be a multicenter, randomized, open label, parallel-group, 4 arm study which is intended to evaluate the safety and efficacy of Tacrolimus 0.03% and 0.1% ointment (Biocon’s formulation) in comparison with Protopic® 0.03% and 0.1% ointment (Astellas Pharma ) in patients (children and adults) with atopic dermatitis after 21 days of treatment. Patients meeting the eligibility criteria will be randomized in 1:1:1:1 ratio to the treatment arms. Patient (children and adults) will receive topical application of either Tacrolimus 0.03% for children or 0.1% ointment for adults (Biocon’s formulation) or Protopic® 0.03% for children and 0.1% ointment for adults (Astellas Pharma) for a duration of 21 days and will be followed up for another 7 days. The study will recruit 378 patients only from India. This study is sponsored by Biocon Limited with Six study centers across India.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 378
- •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.
- •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 immunosuppressant’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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in Investigators Global Assessment (IGA) scale from baseline with Tacrolimus 0.03% and 0.1% ointment (Biocon’s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatment 21 days of treatment
- Secondary Outcome Measures
Name Time Method Percentage change in Eczema Area and Severity Index (EASI) score from baseline with Tacrolimus ointment 0.03% and 0.1% (Biocon’s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatment 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 (Biocon’s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatment 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 (Biocon’s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatment 21 days of treatment
Trial Locations
- Locations (7)
Father Muller Medical College and Hospital
🇮🇳Udupi, KARNATAKA, India
Naik Skin Clinic,
🇮🇳Bangalore, KARNATAKA, India
Prasad Skin, Hair and cosmetology Clinic
🇮🇳Bangalore, KARNATAKA, India
Radiant Skin Clinic
🇮🇳Bangalore, KARNATAKA, India
Rajbal Skin Clinic
🇮🇳Bangalore, KARNATAKA, India
S P Clinic
🇮🇳Bangalore, KARNATAKA, India
Vish Skin Clinic
🇮🇳Udupi, KARNATAKA, India
Father Muller Medical College and Hospital🇮🇳Udupi, KARNATAKA, IndiaDr Ramesh BhatPrincipal investigator09845084224rameshderma@gmail.com