NCT02896101已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (Pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).
Glenmark Pharmaceuticals Ltd. India27 个研究点 分布在 1 个国家目标入组 755 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 755
- 试验地点
- 27
- 主要终点
- The proportion of subjects in each treatment group with treatment success (i.e., a grade of clear or almost clear; a score of 0 or 1, within the treatment area) based on the IGA of Disease Severity at the end of treatment (Visit 3; Day 15 ± 3).
研究概览
简要总结
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating female subjects 12 years of age and older.
- •Non-immunocompromised, with a clinical diagnosis of mild to moderate AD that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable.
- •Confirmed diagnosis of AD for at least 3 months using the diagnostic features as described by Hanifin and Rajka.
- •IGA score of 2 (mild) or 3 (moderate) and ≥ 5% BSA affected at baseline.
排除标准
- •Active cutaneous bacterial, viral or fungal infection in any treatment area at baseline (e.g., clinically infected AD).
- •Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline and history or presence of skin conditions that would interfere with evaluations.
- •History or presence of Netherton's Syndrome, immunological deficiencies or diseases, organ transplant, HIV, diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant severe renal insufficiency or severe hepatic disorders.
- •Use within one month before baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) psoralen plus ultraviolet A therapy (PUVA), 4) tanning booths, 5) non-prescription ultraviolet (UV) light sources, 6) immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) tacrolimus or 10) pimecrolimus.
- •Use within 14 days before baseline of: 1) systemic antibiotics, 2) calcipotriene or other vitamin D preparations, or 3) retinoids.
- •Use within 7 days before baseline of: 1) antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products.
研究组 & 干预措施
Pimecrolimus Cream, 1%
Experimental
Pimecrolimus Cream, 1 % (Glenmark Pharmaceuticals Ltd) topical application
干预措施: Pimecrolimus Cream, 1% (Drug)
Elidel®
Active Comparator
Elidel® (Valeant Pharmaceuticals North America LLC) topical application
干预措施: Elidel® (pimecrolimus) Cream (Drug)
Placebo
Placebo Comparator
Placebo of Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) topical application
干预措施: Placebo of Pimecrolimus Cream, 1% (Drug)
结局指标
主要结局
The proportion of subjects in each treatment group with treatment success (i.e., a grade of clear or almost clear; a score of 0 or 1, within the treatment area) based on the IGA of Disease Severity at the end of treatment (Visit 3; Day 15 ± 3).
时间窗: Day 15
次要结局
- Change in severity score from baseline to Visit 3 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).(Day 15)
研究者
研究点 (27)
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