A Randomized, Controlled, Open Label, Multicentre, Parallel-Group, Comparing Safety and Efficacy of Pimecrolimus 1% Topical Cream (Biocon’s Formulation) Versus Elidel® 1% Topical Cream (Novartis) in Patients with Atopic Dermatitis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 5
- 主要终点
- Percentage change in Investigators Global Assessment (IGA) from baseline with Pimecrolimus 1% topical cream (Biocon’s formulation) versus Elidel® 1% topical cream (Novartis) in patients with Atopic Dermatitis after 21 days of treatment
研究概览
简要总结
The study will be a multicentric, randomized, controlled, open label, parallel-group, 2 arm study which is intended to evaluate the safety and efficacy of Pimecrolimus cream 1% w/w (Biocon’s Formulation) in comparison with Elidel® cream 1% (Novartis) in patients (adults and children) with Atopic Dermatitis after 21days of treatment. Patients meeting the eligibility criteria will be randomized in 1:1 ratio to the treatment arms. Patients will receive topical application of either Pimecrolimus cream 1% w/w (Biocon’s Formulation) or Elidel® cream 1% (Novartis) for a duration of 21 days and will be followed up for another 7 days. The study will recruit 246 patients only from India. This study is sponsored by Biocon Limited with five study centers across India.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Male or female patients aged between 2 -75 years •Patients diagnosed with Atopic Dermatitis as per Hanifin and Rajika diagnostic standards •Patient 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.
- •â€¢Patients with an IGA score of 2 (mild) to 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 naïve patients and/or patients receiving treatments for atopic dermatitis other than pimecrolimus 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.
排除标准
- •â€¢Patient has clinically infected Atopic Dermatitis at baseline •Patient with known hypersensitivity to macrolides in general, to pimecrolimus or any excipient of the cream •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 histamines least 7 days prior to the first dosing day or throughout the study.
- •â€¢Current diagnosis or history or any disease, which in the Investigators opinion would contraindicate the use of immunosuppressants, including but not limited to human immunodeficiency virus (HIV) and cancer.
- •â€¢Females who are pregnant, lactating or likely to become pregnant during the study.
结局指标
主要结局
Percentage change in Investigators Global Assessment (IGA) from baseline with Pimecrolimus 1% topical cream (Biocon’s formulation) versus Elidel® 1% topical cream (Novartis) in patients with Atopic Dermatitis after 21 days of treatment
时间窗: 21 days of treatment
次要结局
- Percentage change in Eczema Area and Severity Index (EASI) from baseline with Pimecrolimus 1% topical cream versus Elidel® 1% topical cream (Novartis) in patients 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 from baseline with Pimecrolimus 1% topical cream versus Elidel® 1% topical cream (Novartis) in patients 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 Pimecrolimus 1% topical cream versus Elidel® 1% topical cream (Novartis) in patients with Atopic Dermatitis after 21 days of treatment)