The Efficacy and Safety of Tacrolimus Ointment in Pediatric Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Physician's Global Evaluation of Clinical Response (PhGECR) at Week 4
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in treating the signs and symptoms of moderate (medium level of seriousness) to severe (very serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic [lasting a long time], inflammatory [pain and swelling], immunologically based skin disease with a genetic predisposition [latent susceptibility to disease at the genetic level]) in pediatric participants.
详细描述
This is an open-label (all people know the identity of the intervention) study in pediatric (2-12 years) participants with moderate to severe atopic dermatitis. Participants will be treated with 0.03 percent concentration of tacrolimus ointment which will be applied twice daily for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first. The study visits will consist of 6 visits: pre-study (optional), Baseline, Weeks 1, 2, 3 and 4. The ointment should be applied at least 2 hours before or at least 30 minutes after bathing, showering, shaving, use of sauna, or heavy exercise (i.e. causes sweating). On study visit days, the ointment should be applied at least 2 hours before the visit. Efficacy evaluation will be done at all subsequent study visits in participants receiving study drug for at least 3 consecutive days (minimum of 5 applications) while the participants who will receive at least 1 application of the study drug, will be evaluated for safety. Primary efficacy evaluation will be based on the Physician's Global Evaluation of Clinical Response (PhGECR). Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Participants with a skin disorder other than atopic dermatitis in the treatment area
- •Participant has pigmentation or extensive scarring or pigmented lesions (abnormal area of tissue, such as a wound, sore, rash, or boil) in the areas to be treated which would interfere with rating of efficacy parameters
- •Participant has clinically infected atopic dermatitis at baseline
- •Participants with a known hypersensitivity (altered reactivity to an antigen) to macrolides (drugs exhibiting antibiotic properties) or any excipient of the ointment
- •Participant has a systemic disease, including cancer (abnormal tissue that grows and spreads in the body until it kills) or a history of cancer or Human Immunodeficiency Virus (HIV: a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person), which would contraindicate (medical reasons that prevent a person from using a certain drug or treatment) the use of immunosuppressants
研究组 & 干预措施
Tacrolimus ointment (pediatric)
Tacrolimus ointment, 0.03 percent twice a day for pediatric population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Physician's Global Evaluation of Clinical Response (PhGECR) at Week 4
时间窗: Week 4
The PhGECR scale evaluates the change in the lesions of atopic dermatitis, which is defined as the lesions identified by Investigator for treatment at Baseline only, using scores ranging from, less than 0 to 100: wherein, less than 0=worse, 0-29=no appreciable improvement, 30-49=slight improvement, 50-74=moderate improvement, 75-89=marked improvement, 90-99=excellent improvement and 100=cleared.
次要结局
- Eczema Area and Severity Index (EASI)(Week 1, 2, 3 and 4)
- Participant's Assessment of Treatment Effects(Week 1, 2,3 and 4)
- Participant's Assessment of Itch(Week 1,2, 3 and 4)