A Randomized, Prospective, Multicenter, Double Blind, Parallel Assignment, Placebo Controlled Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® (Pimecrolimus) Cream, 1% in Patients With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 654
- 试验地点
- 27
- 主要终点
- Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
研究概览
简要总结
To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.
To establish superiority of each active treatment over the placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-immuno compromised male or female aged 8 years and older
- •Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)
- •Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable.
- •A diagnosis of AD for at least 3 months
- •An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3)
- •Affected area of AD involvement at least 5% body surface area (BSA)
- •Treated with a bland emollient for at least 7 days
排除标准
- •Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
- •Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
- •Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations
- •History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
- •History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders
- •Concurrent disease or treatment likely to interfere with the study treatment or evaluations
- •Known allergy or hypersensitivity to pimecrolimus or any other component of the drug products
- •Not willing to minimize or avoid natural and artificial sunlight exposure during treatment
研究组 & 干预措施
Test
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
干预措施: Pimecrolimus Cream, 1% (Drug)
Reference Standard
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
干预措施: Pimecrolimus Cream, 1% (Drug)
Placebo
Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
干预措施: Placebo Cream (Drug)
结局指标
主要结局
Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
时间窗: Day 15
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
时间窗: Day 15
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
次要结局
- Change in Severity of Four Individual Signs and Symptoms(Day 15)
- Evaluation of Application Site Reactions(Day 15)